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2

Optimizing Postoperative Pain Management: Role of Local Anesthetics

Agenda

11:30 a.m. – 11:35 a.m. Welcome and Introductions Julie Golembiewski, Pharm.D., FASHP 11:35 a.m. – 12:10 p.m. Analysis and Implementation of Analgesic Delivery Systems

for Managing Postoperative Pain Virginia L. Ghafoor, Pharm.D. 12:10 p.m. – 12:45 p.m. Incorporating Current Guidelines for Multimodal Pain

Management into Postoperative Order Sets Leslie N. Schechter, Pharm.D. 12:45 p.m. – 1:20 p.m. Role of Local Anesthetics in Managing Postoperative Pain Julie Golembiewski, Pharm.D., FASHP 1:20 p.m. – 1:30 p.m. Faculty Discussion and Audience Questions

Faculty

Julie Golembiewski, Pharm.D., FASHP, Activity Chair Clinical Pharmacist, Anesthesia and Pain University of Illinois Hospital and Health Sciences System Clinical Associate Professor Colleges of Pharmacy and Medicine University of Illinois at Chicago Chicago, Illinois Virginia L. Ghafoor, Pharm.D. Pharmacy Specialist, Pain Management University of Minnesota Medical Center Minneapolis, Minnesota Leslie N. Schechter, Pharm.D. Advanced Practice Pharmacist, Pain Management and Nutritional Support Thomas Jefferson University Hospital Clinical Assistant Professor Philadelphia College of Pharmacy University of the Sciences Philadelphia, Pennsylvania

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Disclosure Statement

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP Advantage requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations.

All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP Advantage and required to disclose any relevant financial relationships with commercial interests. ASHP Advantage identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity.

The faculty listed below report the following relationships pertinent to this activity:

Julie Golembiewski, Pharm.D., FASHP, declares that she has served on the pharmacist advisory board for Pacira Pharmaceuticals, Inc.

Virginia L. Ghafoor, Pharm.D., declares that she has served on the pharmacist advisory board for Pacira Pharmaceuticals, Inc.

Leslie N. Schechter, Pharm.D., declares that she has served on the pharmacist advisory board for Pacira Pharmaceuticals, Inc.

The following faculty and planners report no relationships pertinent to this activity:

Susan R. Dombrowski, M.S., B.S.Pharm.

Carla J. Brink, M.S., B.S.Pharm.

ASHP staff has no relevant financial relationships to disclose.

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Activity Overview

Despite an increasing focus on improvement in pain management in the postsurgical setting and publication of guidelines and standards by government and health care agencies, suboptimal management of postoperative pain continues to be a problem. New therapeutic options and delivery systems have been developed to deliver analgesics more effectively for a longer period of time, but these can add a layer of complexity that health care systems must evaluate to ensure safe and effective implementation. This activity will begin with a review of factors to consider when analyzing analgesic delivery systems and developing guidelines for safe use. The multimodal approach for pain management will be discussed, including a review of therapeutic options and roles for pharmacists. The role of local anesthetics as a component of a multimodal approach for managing postoperative pain will also be discussed.

Learning Objectives

At the conclusion of this application-based educational activity, participants should be able to

Outline a plan for ensuring the safe and effective use of analgesic delivery systems for managing postoperative pain.

Explain key recommendations in recently released guidelines on the management of postoperative pain.

Review postoperative order sets to ensure that multimodal therapy has been incorporated in the pain management regimen.

Discuss the role of local anesthetics for managing postoperative pain.

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CPE Processing Instructions 1. Write down the Attendance Code for each session you attend. These codes are announced

during each session. If you miss the code, check with the Room Monitor at the session.

2. Log in to ASHP’s eLearning Portal using your username and password. http://elearning.ashp.org

3. Click on My Learning Activities. Then click on 2013 – Midyear Clinical Meeting & Exhibition (Orlando, FL) under Conferences.

4. At the bottom of the page is a field for redeeming Attendance Codes (formerly called CE codes). Enter the Attendance Code(s) from each session, and click Submit.

Tip: If your code is not redeeming successfully, verify that you have clicked on the title of your conference in order to access the Attendance Code field, not the Enrollment Code field.

5. Each session will be listed under Your Sessions. Click Claim Credit for a session.

6. Click on the name of a session and complete the requirements for the session.

7. Click Claim Credit for your profession. It is important that you select the correct profession. Pharmacists and Pharmacy Technicians: Fill in your NABP eProfile ID and birth month

and date. Check the box at the bottom and click Claim. You will see a message advising you whether or not your credits were claimed successfully. Your CPE credit will be reported directly to CPE Monitor.

Other (International, Students, etc.): Use ASHP Statement of Completion. Check the box at the bottom and click Claim.

You may print your statement of credit by clicking on Print Statement of Credit. If you require a reprint of a statement of credit, you can return here at any time to print a duplicate.

Exhibitors: Additional First Steps

1. Login to www.ashp.org/exhibitorce with your ASHP username and password.

2. Click on the Get Started button.

3. Select the 48th ASHP Midyear Clinical Meeting & Exhibition from the dropdown menu.

4. Select your Exhibiting Company from the list of exhibitors. From here, follow the instructions above.

ASHP is now using the eLearning Portal (http://elearning.ashp.org) for CE Processing, which allows ASHP to report pharmacy credits via CPE Monitor. For more information, visit www.ashp.org/CEtransition

Pharmacists and Pharmacy Technicians: To process your CE on the eLearning Portal, you must enter your NABP e-Profile ID and birth month and date. After you have entered this information once it is saved for future CE processing. You may obtain your eProfile ID at www.nabp.net.

There may be different directions for workshops and review courses.

Date of Activity:

Tuesday December 10, 2013

Attendance Code: M _ _ _ _ _ CPE Hours: 2.0

NEED HELP? Email [email protected]

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Virginia L. Ghafoor, Pharm.D. Pharmacy Specialist, Pain Management University of Minnesota Medical Center Minneapolis, Minnesota Virginia L. Ghafoor, Pharm.D., is Pharmacy Specialist in Pain Management at University of Minnesota Medical Center in Minneapolis. For more than 10 years, she has been instrumental in developing pharmacy services for acute and chronic pain management at the University of Minnesota Medical Center and throughout the Fairview health system. She advocates for pain medication safety, promotes pharmacy pain medication stewardship, and leads the health system’s Pain Medication Committee to advance evidence-based practice standards. Dr. Ghafoor earned her Doctor of Pharmacy degree from the University of Nebraska Medical Center in Omaha. Early in her career she received a two-year fellowship award from the American Society of Health-System Pharmacists (ASHP) Research and Education Foundation for oncology research at University of Wisconsin-Madison, and the fellowship involved working with nationally recognized leaders in cancer and pain management research. Before assuming her current position, Dr. Ghafoor was on the faculty at the University of Rhode Island (URI) College of Pharmacy and conducted research and pharmacy education programs in pain management at Rhode Island Hospital in Providence. During this time she also developed an ASHP-accredited pharmacy practice residency program for the URI College of Pharmacy. Dr. Ghafoor has authored several articles on pain topics, including intrathecal pumps, palliative sedation, and patient-controlled analgesia. She has also contributed chapters on pain management to the texts, Koda-Kimble and Young’s Applied Therapeutics: The Clinical Use of Drugs, Smart Infusion Pumps published by ASHP, and Core Curriculum for Pain Management Nursing published by American Society of Pain Management Nurses. Dr. Ghafoor is a member of ASHP and Minnesota Society of Health-System Pharmacists. She currently serves on the ASHP Advisory Group for Pain Management and Palliative Care.

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Analysis and Implementation of Analgesic Delivery Systems for Managing Postoperative Pain

Virginia L. Ghafoor, Pharm.D.

University of Minnesota Medical Center

Minneapolis, Minnesota

“The purpose of medicine is to prevent significant disease, to decrease pain and to postpone death…Technology has to support these goals, if not, it may even be counterproductive.”

- Dr. Joel J. NobelFounder, ECRI InstituteInventor of the crash cart

Driving Forces for New Pain Management Technology

• Medication safety with “smart” pumps

• Reduction in human operation errors

• Innovation allowing patient control of pain management

• Device mobility with care transitions

• Recalls due to a design problem or operation failure

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What is your biggest concern about the safety of pain medication devices?

a. Medication overdose

b. Programming errors

c. Lack of staff expertise

d. Recall due to defect

Safety Recommendations

• Use smart infusion technology with dosage error reduction software (DERS)

Reference: Safe use of opioids in hospitals. The Joint Commission Sentinel Event Alert, Issue 49, August 8, 2012. URL in ref list.

• Process for handling elastomeric pain relief pump

Reference: Institute for Safe Medication Practices, Newsletter July 16, 2009. URL in ref list.

Building Safe Practice Around High-Risk Medication Devices

• Expertise and training for high-risk routesExample: Intrathecal, epidural, and nerve blocks

restricted to anesthesia and certified specialists

• Patient care policies to guide monitoringExample: Pain assessment, vital signs, and

capnography

• Order sets for high-risk medicationsExample: Opioids and local anesthetics

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The Balancing ActExample: Device Selection for Local Anesthetics

Parameter Electronic Pump Elastomeric Pump

Pro Con Pro Con

Continuous infusion

-Drug volumeindicator

-One-time cost (reusable)

-Smart pumptechnology

-Must beattached to pole (limitsmobility)

-Power source required

-Mobile-Multiplevolumes andinfusion rates

-Recurrent cost(disposable)

-Runaway flowrates

-Not a smartpump

Patient-controlled dose

-Flexible dosesettings

-One-time cost (reusable)

-Smart pump technology

Same as above

-Mobile-Infusion rateplus dosebutton

Same as above

Vetting a Device

“Success is doing ordinary things extraordinarily well.”

- Jim RohnAmerican entrepreneur

KeyStakeholders

Ladak SS et al. Pain Manag Nurs. 2007; 8:140-5.

TEAM

Biomed

Engineer

Supply Chain

IT

Specialist

Pharmacy Staff

Nursing Staff

Physician Staff

Finance Member

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“Teamwork divides the task and multiplies the success.”

- Author Unknown

Assigning Ownership and Responsibility

• Corporate and financial– Contract and purchase of the device

– Budget for costso Staff training

o Trouble shooting problems

o Drug library upgrades for smart pumps

o Risk management and quality improvement processes

• Technology, engineering, and supply chain– Software integration and maintenance of computer

– Device maintenance

Assigning Ownership and Responsibility

• Clinical departments and practitioners– Device policy and procedure

– Order sets, guidelines for dispensing and administration

• Quality assurance and performance improvement– Monitor medical device hardware failures and recalls

– Review manual overrides for the device

– Evaluate medication errors related to device

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“Price is what you pay. Value is what you get.”

- Warren BuffettAmerican business magnate

What do you think is the most important attribute when vetting a new device?

a. Safety features

b. Price

c. Health care provider satisfaction

d. Ease of implementation

Value AnalysisValue of a device is determined by estimating how well it performs, divided bythe cost

– Customer focused

– Process oriented

– Data-driven (Example: MAUDE data)

Phelps PK et al. In Phelps PK, ed. Smart infusion pumps. ASHP; 2011:9-26.

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MAUDE DATA(Manufacturer and User Facility Device Experience)

• FDA database for device events

• Example of a real-time search– Product class: Pump, infusion, elastomeric

– Event type: Injury

– Date: 1/1/2013 through 9/30/2013

– Results: 159 records (2 deaths)

– Commonly reported: runaway flow rate where elastomeric pump delivered local anesthetic faster than the rate setting

In vetting a process, adverse event data would disqualify adevice unless safety improvements have been made

Weighted MatrixWeighted-matrix recognizes medical device attributes that must be present

– Weight of attribute indicates level of desire for a feature

– Attribute score is the performance of the device

– Total weighted score for the device is obtained by multiplying weight of attribute by the attribute score

Medical device with the highest total weighted scoreindicates it is the best performer


Example: Weighted Decision MatrixAttribute Weight of

attribute(1-10 scale)

Attribute score for Pump #1

(1-4 scale)

Total weighted score for Pump #1

Attribute score for Pump #2

(1-4 scale)

Total weighted score for Pump #2

Vendor provides staff educationmaterials

6 4 24(6 x 4)

2 12(6 x 2)

Vendor offerscontinuing education

1 2 2(1 x 2)

4 4(1 x 4)

TOTAL 26 16


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Failure Mode and Effects Analysis (FMEA)

Croteau RJ. Jt Comm J Qual Patient Saf. 2010; 36:348-50.

“A systematic method of examining a process prospectively for possible ways in which failure can occur and the redesigning of the process to eliminate the possibility of the failure, stop the failure before it harms an individual, or minimize the consequences of the failure”

Methods• The hazard score is the

product of the severity and probability scores

• Each item wasdetermined to bedetectable (Yes/No)based on whether or notthe failure mode would bedetected before reachingthe patient

Rating Severity Probability

1-3 Minor Doubtful

4-6 Moderate Possible

7-9 Major Likely or Probable

10 Catastrophic Absolute

FMEA ResultsExample from the University of Minnesota Medical Center

Epidural Pump Failure Mode

Predicted Effect

S F D HS Action Plan New S/F/HS

Change Occur?

Key not available to unlock pump

Delay in use of pump and pain control

7 8 Y 56 Know plan for placement of keys so additional keys can be obtained from known location quickly

2/8/16 -71% Yes

Medication delivery by proxy

Overseda-tion and patient harm

8 7 N 56 Cards are attached to the button warning against PCEA by proxy

8/4/32 -43% No

Extension tubing cannot deliver ordered volume

Unable to use pump set-up for patient

8 9 Y 72 2 sizes of tubing purchased

Staff communication

Linking of order with tubing size recommendations

8/4/32 -55% No

S= SeverityF= FrequencyD= DetectabilityHS= Hazard score

See page 18 for enlarged view

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Limitations of FMEA

• Little research on the reliability and validityof the FMEA process and output

• Severity, frequency, and detectabilityscores are subjective

• Variation in hazard score interpretation

• Follow up required to make sure potentialproblem is resolved

Franklin BD et al. BMJ Qual Saf. 2012; 21:607-11.

“Stay committed to your decisions but flexible in your approach.”

- Tom RobbinsAmerican author

Conclusion

• Value analysis is fundamental to theselection of pain management devices

• Safety is an important attribute not to beoverlooked when acquiring newtechnology

• FMEAs are valuable for prospectiveidentification of problems prior toimplementation of a device

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FMEA ResultsExample from the University of Minnesota Medical Center

Epidural Pump Failure Mode

Predicted Effect

S F D HS Action Plan New S/F/HS

Change Occur?

Key not available to unlock pump

Delay in use of pump and pain control

7 8 Y 56 Know plan for placement of keys so additional keys can be obtained from known location quickly

2/8/16 -71% Yes

Medication delivery by proxy

Overseda-tion and patient harm

8 7 N 56 Cards are attached to the button warning against PCEA by proxy

8/4/32 -43% No

Extension tubing cannot deliver ordered volume

Unable to use pump set-up for patient

8 9 Y 72 2 sizes of tubing purchased

Staff communication

Linking of order with tubing size recommendations

8/4/32 -55% No

S= SeverityF= FrequencyD= DetectabilityHS= Hazard score

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Selected References

1. Croteau RJ. Risk assessing risk assessment. Jt Comm J Qual Patient Saf. 2010; 36:348-50,337.

2. Franklin BD, Shebl NA, Barber N. Failure mode and effects analysis: too little for too much?BMJ Qual Safe. 2012; 21:607-11.

3. Institute for Safe Medication Practices. Process for handling elastomeric pain relief balls(ON-Q PainBuster and others) requires safety improvements. July 16, 2009.http://www.ismp.org/newsletters/acutecare/articles/20090716.asp (accessed 2013 Oct 29).

4. The Joint Commission. Safe use of opioids in hospitals. Sentinel event alert. Issue 49,August 8, 2012.http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf (accessed2013 Oct 29).

5. Ladak SS, Chan VW, Easty T et al. Right medication, right dose, right patient, right time,and right route: how do we select the right patient-controlled (PCA) device? Pain ManagNurs. 2007; 8:140-5.

6. Phelps PK, ed. Smart infusion pumps: implementation, management, and drug libraries.Bethesda, MD: American Society of Health-System Pharmacists; 2011.

7. Phelps PK, Kleinke PL. Choosing a pump: the request for proposal and value analysis. In:Phelps PK, ed. Smart infusion pumps: implementation, management, and drug libraries.Bethesda, MD: American Society of Health-System Pharmacists; 2011:9-26.

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Leslie N. Schechter, Pharm.D. Advanced Practice Pharmacist, Pain Management and Nutritional Support Thomas Jefferson University Hospital Clinical Assistant Professor Philadelphia College of Pharmacy University of the Sciences Philadelphia, Pennsylvania

Leslie N. Schechter, Pharm.D., is Advanced Practice Pharmacist specializing in pain management and nutritional support at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. She is also Clinical Assistant Professor at Philadelphia College of Pharmacy at the University of the Sciences and Adjunct Assistant Professor at Temple University School of Pharmacy in Philadelphia. She serves as a preceptor for Doctor of Pharmacy students at Jefferson School of Pharmacy.

At Thomas Jefferson University Hospital (TJUH), Dr. Schechter serves as Pharmacy Liaison for the Acute Pain Management Service (APMS) and is involved in APMS clinical trials. She also provides pharmacotherapy recommendations relating to pain management, conducts medication use reviews related to pharmaceutical pain management therapy, and is involved in the drug review process for formulary addition considerations for anesthesia and pain medications. Dr. Schechter is a member of the TJUH Pain Initiative, an interdisciplinary group that developed a booklet of pain management guidelines, which is updated periodically and distributed to all medical, surgical, nursing, and pharmacy staff.

Dr. Schechter earned her Bachelor of Science degree in pharmacy from the Virginia Commonwealth University’s Medical College of Virginia in Richmond and her Doctor of Pharmacy degree from Purdue University College of Pharmacy and Pharmaceutical Sciences in West Lafayette, Indiana. She completed a residency accredited by the American Society of Health-System Pharmacists (ASHP) at the Medical College of Virginia Hospitals.

Dr. Schechter is a member of ASHP and the American Society for Parenteral and Enteral Nutrition. She has contributed chapters to several textbooks on pain management, including The Essence of Analgesia and Analgesics (Cambridge University Press), Handbook of Drug-Nutrient Interactions (Humana Press), Acute Pain Management, 1st ed. (Cambridge University Press), and Textbook of Regional Anesthesia and Acute Pain Management (McGraw-Hill). She has also authored several articles related to pain management. She is frequently invited to speak on topics related to pain management for interdisciplinary health care audiences.

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Incorporating Current Guidelines for Multimodal Pain Management

into Postoperative Order Sets

Leslie N. Schechter, Pharm.D.

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania

Pain by the Numbers

• Of the 80% of patients undergoing surgery who experience postoperative pain– Fewer than 50% report adequate pain relief1

• Of these, 86% report the pain as moderate, severe, or extreme

– 10% to 50% of patients with postoperative pain develop chronic pain (surgical procedure dependent)2

• For 2% to 10% of these patients, the chronic pain is severe

1Apfelbaum JL et al. Anesth Analg. 2003; 97:534-40.2Kehlet H et al. Lancet. 2006; 367:1618-25.

The Joint Commission Standards

• Right of patients to appropriate assessment and management of pain

• Screen patients for pain – During their initial assessment

– When clinically required

– Ongoing periodic re-assessments

• Educate patients and families about pain management

The Joint Commission. Facts about pain management. URL in ref list.

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Hospitals Are Accountable for Adequate Pain Management

• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) hospital survey

• Summary measures or composites summarize– How well nurses and doctors communicate

– How responsive hospital staff are to patients’ needs

– How well hospital staff help patients manage pain

– How well the staff communicates about medicines

– Whether key information is provided at discharge

Centers for Medicare & Medicaid Services. HCAHPS Fact Sheet (CAHPS® Hospital Survey). August 2013. URL in ref list.

Acute Pain Practice Guidelines

• Institute of Medicine (IOM) report, “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research” (2011)

• American Society of Anesthesiologists Task Force report: Practice Guidelines for Acute Pain Management in Perioperative Setting (2012)

• American Society of Anesthesiologists Task Force report: Practice Guidelines for Postanesthetic Care (Apfelbaum JL et al., 2013)

• PROSPECT: Evidenced-based, procedure-specific postoperative pain management (2013)

IOM: Relieving Pain in America

• Full report available online (364 pages) – Relieving Pain in America: A Blueprint for Transforming

Prevention, Care, Education, and Research

• 2010 Patient Protection and Affordable Care Act – Required U.S. Department of Health and Human Services

(DHHS) to enlist IOM in examining pain as public health problem

• IOM– Assessed the state of the science regarding pain research,

care, and education

Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research, 2011. URL in ref list.

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IOM: Relieving Pain in America

• IOM report – Provides recommendations for improving acute and

chronic pain management• Cultural, educational, and research methods

• Limited information on appropriate selection of therapeutic modalities

• No report available evaluating progress

• Use other guidelines for specific therapeutic evidence-based options

Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research, 2011. URL in ref list.

2012 Practice Guidelines for Acute Pain Management in the Perioperative Setting

• Updated 2004 Practice Guidelines

• October 2012– American Society of Anesthesiologists (ASA)

Committee on Standards and Practice Parameters

• Collected new evidence to determine whether existing 2004 guidelines were supported by current evidence

American Society of Anesthesiologists. Anesthesiology. 2012; 116:248-73.


• Pain management in the perioperative setting– Actions before, during, and after a procedure – Intended to reduce or eliminate pain before discharge

• New evidence includes– Updated evaluations of scientific literature– Surveys of experts and randomly selected ASA

members

• Recommendations: NOT changed

American Society of Anesthesiologists. Anesthesiology. 2012; 116:248-73..

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• Purpose of the guidelines– Facilitate safety and effectiveness of acute

pain management

– Reduce risk of adverse outcomes

– Maintain patient’s functional abilities, physical,and psychologic well being

– Enhance quality of life



• Application– Intended use

• Anesthesiologists

• Individuals under their supervision

– Resource• Health care providers managing postoperative

pain

• Policymakers to promote effective and patient-centered care


Pathophysiologic ResponsesAssociated with Trauma

Adapted from Ghori MK et al. In Sinatra RS et al., eds. Acute pain management. 2009:24.


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Adverse Outcomes Associated with the Management of Perioperative Pain

• Respiratory depression• Sedation• Circulatory depression• Nausea and vomiting• Pruritus• Urinary retention• Impairment of bowel function• Sleep disruption


Preoperative Evaluation of the Patient

• Patient factors to consider– Type of surgery

– Expected severity of postoperative pain

– Underlying medical conditions• Sleep apnea

• Allergies

• History of opioid use

– Risk-benefit ratio for the available techniques andmedications

– Patient preferences or previous experience


Case Scenario

• Cardiothoracic surgeons at your institutionprovide pain management using a prescriber-specific, reactive approach to postoperative painmanagement

• Pain management is opioid driven– Opioids prescribed as needed (PRN) immediately

postoperative, followed by acetaminophen and opioidcombination products PRN

• They seek your input about how to improvepostoperative pain management

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What recommendations could you offer to improve pain management for patients having cardiothoracic surgery?

a. Order PCA morphine, then long-acting opioidsaround clock

b. Order PCA morphine followed by short-actingopioids PRN

c. Add multimodal non-opioid therapy aroundclock

d. Continue current approach – has beenmodestly effective

PCA = patient-controlled analgesia

Perioperative Techniques for Pain Management: Therapeutic Options• Epidural or intrathecal opioids• Systemic opioid PCA• Peripheral regional techniques

– Intercostal blocks– Plexus blocks– Local anesthetic infiltration of incisions

• Catheter placement with continuous infusion• Prior to suturing, local anesthetic injection

• Consider risks and benefits for the individualpatient

• Avoid intramuscular (IM) injections as needed

American Society of Anesthesiologists. Anesthesiology. 2012; 116:248-73..

Multimodal Analgesia• Pain involves multiple mechanisms

• Multimodal analgesia– Administration of two or more drugs that act by

different mechanisms either via the same route or bydifferent routes of administration

• Opioid and non-opioid analgesics– Acting at different sites within the central and

peripheral nervous systems

– Goal• Additive or synergistic effects

• Diminish or eliminate adverse effects

• Fewer analgesic gaps


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Multimodal Approach

Adapted from Gottschalk A et al. Am Fam Physician. 2001; 63:1979-84.

PainPain

Trauma

Descending modulationAscending

input

Opioids 2-Agonists Centrally acting analgesicsAnti-inflammatory agentsAcetaminophen

Dorsal horn

Local anestheticsOpioids 2-Agonists

Spinothalamic tract

Dorsal root ganglion

Local anesthetics

Peripheral nociceptors

Local anesthetics Anti-inflammatory agentsIce

Multimodal Analgesia• Consider the following as part of non-opioid

multimodal therapy– Acetaminophen– NSAIDs (selective or nonselective COX inhibitors)– Gabapentinoids (pregabalin, gabapentin)

• Unless contraindicated, administer around-the-clock and not as needed

• Individualize choice of medication, dose, route,and duration of therapy


COX = cyclooxygenaseNSAIDs = nonsteroidal anti-inflammatory drugs

Opioids - Pure Mu Agonists • Considered drugs of choice for moderate to severe pain• Little difference in ability to relieve pain• Unrelieved pain usually not a reason to switch agents

– Pain relief is dose related

• No ceiling effect to analgesia for pure mu-agonists• Consider minimizing the opioid peak concentration

– Decrease dose– Decrease dosing interval while maintaining the same 24-hour

total dose

• Adverse effects– Sedation, nausea, constipation, respiratory depression, pruritus,

urinary retention

Trescot AM et al. Pain Physician. 2008; 11(Suppl 2):S133-53..


27

FDA News Release: September 10, 2013

• Class-wide safety labeling changes and newpostmarket study requirements for all ER and LA opioid analgesics

• Updated indication for ER and LA opioids– Management of pain severe enough to require daily,

around the clock, long-term opioid treatment and forwhich alternative treatment options are ineffective, nottolerated, or inadequate to provide sufficientmanagement of pain

– NOT indicated for PRN pain relief

ER = extended releaseLA = long acting

U.S. Food and Drug Administration. News release. September 10, 2013. URL in ref list.

FDA News Release: September 10, 2013

• FDA requiring drug companies to conductfurther studies and clinical trials– More information needed to assess the serious risks

associated with long-term use of ER and LA opioids• Misuse, abuse, hyperalgesia, addiction, overdose, and death

• New boxed warning– Chronic maternal use during pregnancy can result in

neonatal opioid withdrawal syndrome (NOWS)

• Modification of ER and LA opioid REMS

REMS = Risk Evaluation and Mitigation Strategy

U.S. Food and Drug Administration. News release. September 10, 2013. URL in ref list.

FDA News Releases: October 24 and 25, 2013

• Will submit to DHHS by early December 2013– Formal recommendation to reclassify hydrocodone

combination products into Schedule II

• Approved hydrocodone bitartrate extended-release capsules– Schedule II

– Single entity (no acetaminophen)

U.S. Food and Drug Administration. News release. October 25, 2013. URL in ref list. U.S. Food and Drug Administration. Statement on proposed hydrocodone

reclassification. October 24, 2013. URL in ref list.

28

REMS for ER and LA Opioids• Approved by FDA on July 9, 2012

– Part of national prescription drug abuse plan announced by Obama Administration in 2011 to combat prescription misuse and abuse

• Focus– Educating prescribers about proper pain management– Selecting suitable patients– Improving patient awareness of risks

• Physician training about opioids not mandatory– Some federal agencies working to get Congress to link

mandatory physician training to DEA registration number– Obama Administration pursuing modification of Controlled

Substances Act to require training to obtain and renew DEAregistration

U.S. Food and Drug Administration. Questions and answers: REMS for ER/LA opioid analgesics. July 9, 2012. Updated March 1, 2013. URL in ref list.

Acetaminophen• Exact mechanism unclear, current evidence points to

variety of central and peripheral mechanisms– Inhibition of centrally-acting cyclooxygenase with very weak

peripheral effects

• Central effects may explain antipyretic effect

• Minimal peripheral effects – Lack of gastric irritation and clottingabnormalities

– Interaction with various neurotransmitters and modulators controlling pain processing and perception (serotonergic and cannabinoid systems)

• Contraindicated in patients with severe hepaticimpairment

Smith HS. Pain Physician. 2009; 12:269-80.

AcetaminophenDosing Considerations

• FDA changes on January 13, 2011– Limit strength of acetaminophen in prescription, combination

products to 325 mg per tablet– Boxed warning on prescription products - potential for severe

liver injury– Pharmacists: notify prescribers when acetaminophen dosage in

combination product can exceed 3000 mg in any 24-hr period

• McNeil Pharmaceuticals on July 28, 2011 voluntarilylowered maximum recommended daily dose from 4000mg to 3000 mg in Tylenol products

• Maximum safe dose of acetaminophen remains 4000 mgper day

U.S. Food and Drug Administration. FDA drug safety communication. January 13, 2011. URL in ref list.

29

Intravenous Acetaminophen

• Alternative to intravenous NSAIDs formanagement of postoperative pain– Avoid NSAID adverse effects

• Alternative to oral and rectal acetaminophen– Oral administration may not be feasible immediately

after surgery

– Rectal administration produces slow andunpredictable absorption

• Consider single dose, then convert to oral

Nonselective NSAIDs• Mechanism of action

– Inhibition of prostaglandin biosynthesis vianonselective inhibition of cyclooxygenase enzymes

• Adverse effects similar for all products– Gastrointestinal ulceration

• Inhibiting prostaglandins involved in protection of GI mucosa

– Prolonged bleeding• Inhibiting platelet thromboxane A2 synthesis resulting in

inhibition of platelet aggregation

– Renal impairment• Inhibiting renal prostaglandins

Bookstaver PB et al. J Pain Res. 2010; 3:67-79.GI = gastrointestinal

NSAIDs• Intravenous and oral NSAIDs

– Decrease opioid requirements

– Decrease incidence of adverse events

• No clinical trials showing comparative efficacy ofIV ketorolac and ibuprofen

• Duration of IV ibuprofen currently not restricted– Only studied for up to 5 days

– Use with caution for > 5 days

Pavy TJ et al. Anesth Analg. 2001; 92:1010-4.Southworth S et al. Clin Ther. 2009; 31:1922-35.

30

Anticonvulsants• Gabapentin and pregabalin

• Mechanism: bind to alpha-2-delta subunitof the N-type voltage gated calciumchannel– Propensity to dampen neuronal excitability

– Used primarily for neuropathic pain

• Results in decreased release of substanceP, calcitonin gene-related peptide,glutamate

Weinbroum AA. Pharmacol Res. 2012; 65:411-29.Clarke H et al. Anesth Analg. 2012; 115:428-42.

Anticonvulsants: Dosing• Pregabalin

– Preoperative dose: 150-300 mg

– Continued therapy: 75-150 mg twice daily forup to 14 days after surgery

• Gabapentin– Preoperative dose: 300-1200 mg

• 600 mg – optimal in dose-response study

– Postoperative therapy: 100-600 mg threetimes daily for 2-10 days

Clarke H et al. Anesth Analg. 2012; 115:428-42.

Ketamine• Renewed interest in enhancing postoperative

analgesia

• Antagonist at NMDA receptor

– At low sub-anesthetic doses, exerts a specific NMDAblockade, modulating central sensitization induced bythe incision and tissue damage

– By blocking NMDA receptors, can reducedevelopment of tolerance

• Opioid-sparing effect with advantages in patientslikely to have high postoperative opioidconsumption

Weinbroum AA. Anesth Analg. 2003; 96:789-95.Yamauchi et al. Anesth Analg. 2008; 107:1041-4.NMDA = N-methyl-D-aspartate

31

Ketamine: Dosing• Perioperative ketamine use in RCT1

– Reduced opioid dose by 30%– Reduced chronic post-surgical pain syndromes

• Dose2

– 0.1 - 0.5 mg/kg bolus 0.1- 0.5 mg/kg/hr infusion– Adverse effects: < 10% of patients complained of psycho-cognitive

effects (were opioid-naïve, rarely seen in opioid-tolerant patients)

• Protocol in adult patients with chronic opioid use (TJUH)– Initial bolus with 15 mg; may repeat x 1– Begin infusion at 1 mg/hr– 5-mg bolus doses prior to infusion rate increases– Increase infusion up to 15 mg/hr (higher doses require attending

physician approval)

1Lavand’homme P et al. Anesthesiology. 2005; 103:813- 20.2Visser E et al. Biomed Pharmacother. 2006; 60:341-8.

TJUH = Thomas Jefferson University Hospital

2013 American Society of Anesthesiologists Task Force Report: Practice Guidelines for

Postanesthetic Care

• Updated 2002 practice guidelines• Collected new evidence to determine

whether existing 2002 guidelinessupported by current evidence

• Purpose: improve postanesthetic careoutcomes for patients who just hadanesthesia or sedation and analgesia care

• Recommendations: NOT changed

Apfelbaum JL et al. Anesthesiology . 2013; 118:291-307.

PROSPECT: Evidenced-based, Procedure-specific Postoperative Pain Management

• Existing general guidelines do not consider– Procedure-specific differences in analgesic efficacy– Applicability of a given analgesic technique

• Website provides information and recommendations forevidence-based procedure-specific postoperative painmanagement– Intensity of pain and consequential effects on organ function

may be procedure related

• PROSPECT Working Group– Conducts systematic reviews of the literature– Includes only randomized, controlled trials of postoperative

interventions compared with placebo or other interventions

PROSPECT: evidenced-based, procedure-specific postoperative pain management. URL in ref list.

32

PROSPECT: Format of Recommendations

• Evidence and recommendations– Organized in a tree structure– Interventions for pain management

• Preoperative• Intraoperative• Postoperative

• For each procedure, overall recommendationssummarized in a table or algorithm

• Abdominal hysterectomy• Colon resection• Hemorrhoid surgery• Herniorraphy

• Laparoscopic cholecystectomy• Non-cosmetic breast surgery• Radical prostatectomy• Total hip and knee arthroplasty

PROSPECT: evidenced-based, procedure-specific postoperative pain management. URL in ref list.

CT surgeons request help modifying their pain regimens. Who should be included in the discussion? Select all that apply.

a. Pharmacists

b. Nurses

c. Cardiothoracic surgeons

d. Pain service staff and anesthesiologists

e. Hospital administration policymakers

Institutional Review of Postoperative Order Sets

• Review preoperative order sets, intraoperativeanesthesia orders, and postoperative order sets– Based on surgical procedure, are appropriate pain

medications ordered before, during, and after surgery?

– If yes, evaluate HCAHPS scores for the surgicalprocedure and surgeon

• If HCAHPS scores are acceptable, continue current regimen

• If HCAHPS scores need improvement, discuss alternative therapy to improve patient pain management

33

Institutional Review of Postoperative Order Sets

• If the order sets do not offer multimodaltherapy or do not follow clinical guidelines– Review HCAHPS scores for the surgical

procedure and surgeon– Set up meeting with surgeons and

anesthesiologists to review HCAHPS dataand clinical guidelines

– Present information for modifying current painregimens in a constructive, informativemanner

Institutional Review of Patient Discharge Instructions for Pain

Management• Review discharge medications and ensure

appropriate medications for pain managementare prescribed upon discharge

• Review the instructions for use and possibleadverse effects with the patient and family

• Work with community pharmacy to ensureprescribed medications are covered under thepatient’s health insurance plan

Changes to TJUH CT Surgery Pain Management Protocol

• Pregabalin 150 mg po x 1 dose pre-op and 75 mg po q12hr x 6 dosespostop

• Acetaminophen 1000 mg IVPB q6hr x 36 hr postop (convert to oral if tolerated), then 1000 mg PO q6hr x 72 hr (adjust dose for patients < 50 kg)

• Postoperative day 0: hydromorphone PRN or PCA– 0.5 mg IV q3hr PRN moderate pain

– 1 mg IV q3hr PRN severe pain

• Postoperative days 1-5– Ketorolac 15 mg IV q6hr x 4 doses (begin 1.5 hours postop), withhold if

contraindicated

– Oxycodone 5 mg orally q4hr moderate pain

– Oxycodone 10 mg orally q4hr severe pain

– Continue hydromorphone IV if not tolerating oral medications

• Other: Bowel regimen and tramadol



34

TJUH Results with Improved Pain Management for CT Surgery Patients

Pre-Implementation

Post-Implementation

Postoperative opioid consumption (morphine equivalents)

222 mg 174 mg

How much pain relief did you experience after each pain treatment?

66% 92%

Thoma BN et al. Poster presentation at 2014 SCCM Meeting.

Conclusion

• Inadequately treated postoperative pain remainsa concern for patients and health systems

• Current clinical guidelines continue toemphasize the importance of multimodal therapy

• Pre-, intra- and postoperative order sets shouldbe reviewed for appropriateness of currentsurgical pain management modalities

• Review and provide HCAHPS scores tosurgeons to support modification ofpostoperative pain management regimens

35

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36

Multimodal Approach

Adapted from Gottschalk A et al. Am Fam Physician. 2001; 63:1979-84.

PainPain

Trauma

Descending modulationAscending

input

Opioids 2-Agonists Centrally acting analgesicsAnti-inflammatory agentsAcetaminophen

Dorsal horn

Local anestheticsOpioids 2-Agonists

Spinothalamic tract

Dorsal root ganglion

Local anesthetics

Peripheral nociceptors

Local anesthetics Anti-inflammatory agentsIce

Changes to TJUH CT Surgery Pain Management Protocol

• Pregabalin 150 mg po x 1 dose pre-op and 75 mg po q12hr x 6 doses postop

• Acetaminophen 1000 mg IVPB q6hr x 36 hr postop (convert to oral if tolerated), then 1000 mg PO q6hr x 72 hr (adjust dose for patients < 50 kg)

• Postoperative day 0: hydromorphone PRN or PCA – 0.5 mg IV q3hr PRN moderate pain

– 1 mg IV q3hr PRN severe pain

• Postoperative days 1-5– Ketorolac 15 mg IV q6hr x 4 doses (begin 1.5 hours postop), withhold if

contraindicated

– Oxycodone 5 mg orally q4hr moderate pain

– Oxycodone 10 mg orally q4hr severe pain

– Continue hydromorphone IV if not tolerating oral medications

• Other: Bowel regimen and tramadol


37


Selected References

1. American Society of Anesthesiologists Task Force on Acute Pain Management. Practiceguidelines for acute pain management in the perioperative setting: an updated report by theAmerican Society of Anesthesiologists Task Force on Acute Pain Management.Anesthesiology. 2012; 116:248-73.

2. Apfelbaum JL, Chen C, Mehta SS et al. Postoperative pain experience: results from anational survey suggest postoperative pain continues to be undermanaged. Anesth Analg.2003; 97:534-40.

3. Apfelbaum JL, Silverstein JH, Chung FF et al for the American Society of Anesthesiologists.Practice guidelines for postanesthetic care: an updated report by the American Society ofAnesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2013; 118:291-307.

4. Bookstaver PB, Miller AD, Rudisill CN et al. Intravenous ibuprofen: the first injectableproduct for the treatment of pain and fever. J Pain Res. 2010; 3:67-79.

5. Centers for Medicare & Medicaid Services. HCAHPS Fact Sheet (CAHPS® HospitalSurvey). August 2013.http://www.hcahpsonline.org/files/August%202013%20HCAHPS%20Fact%20Sheet2.pdf(accessed 2013 Oct 22).

6. Clarke H, Bonin RP, Orser BA et al. The prevention of chronic postsurgical pain usinggabapentin and pregabalin: a combined systematic review and meta-analysis. AnesthAnalg. 2012; 115:428-42.

7. Ghori MK, Zhang YF, Sinatra R. Pathophysiology of acute pain. In: Sinatra RS, de Leon-Casasola OA, Ginsberg B et al, eds. Acute pain management. New York, NY: CambridgeUniversity Press; 2009:24-32.

8. Gottschalk A, Smith DS. New concepts in acute pain therapy: preemptive analgesia. AmFam Physician. 2001; 63:1979-84.

9. Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention,care, education, and research, 2011. Washington, DC: The National Academies Press.http://www.nap.edu/catalog.php?record_id=13172 (accessed 2013 Oct 22).

10. The Joint Commission. Facts about pain management.http://www.jointcommission.org/assets/1/18/pain_management.pdf (accessed 2013 Oct 22).

11. Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention.Lancet. 2006; 367:1618-25.

12. Lavand’homme P, De Kock M, Waterloos H. Intraoperative epidural analgesia combinedwith ketamine provides effective preventive analgesia in patients undergoing major digestivesurgery. Anesthesiology. 2005; 103:813-20.

13. Pavy TJ, Paech MJ, Evans SF. The effect of intravenous ketorolac on opioid requirementand pain after cesarean delivery. Anesth Analg. 2001; 92:1010-4.

14. PROSPECT: evidenced-based, procedure-specific postoperative pain management.http://www.postoppain.org/frameset.htm (accessed 2013 Oct 22).

15. Smith HS. Potential analgesic mechanisms of acetaminophen. Pain Physician. 2009;12:269-80.

38


16. Southworth S, Peters J, Rock A et al. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the managementof postoperative pain. Clin Ther. 2009; 31:1922-35.

17. Thoma BN, Franta K, Schechter L et al. Development and implementation of a post-operative multimodal pain management algorithm for cardiac surgery patients. Posteraccepted for presentation at the Society of Critical Care Medicine 43rd Critical CareCongress, San Francisco, CA: January 9-13, 2014.

18. Trescot AM, Datta S, Lee M et al. Opioid pharmacology. Pain Physician. 2008; 11(Suppl2):S133-53.

19. U.S. Food and Drug Administration. FDA drug safety communication: prescriptionacetaminophen products to be limited to 325 mg per dosage unit; boxed warning willhighlight potential for severe liver failure. January 13, 2011.http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm (accessed 2013 Oct 22).

20. U.S. Food and Drug Administration. Questions and answers: FDA approves a RiskEvaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA)opioid analgesics. July 9, 2012. Updated March 1, 2013.http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm (accessed2013 Nov 1).

21. U.S. Food and Drug Administration. News release: FDA announces safety labeling changesand postmarket study requirements for extended-release and long-acting opioid analgesics.September 10, 2013.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm(accessed 2013 Nov 6).

22. U.S. Food and Drug Administration. Statement on proposed hydrocodone reclassificationfrom Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research. October24, 2013. http://www.fda.gov/drugs/drugsafety/ucm372089.htm (accessed 2013 Nov 1).

23. U.S. Food and Drug Administration. News release: FDA approves extended-release, single-entity hydrocodone product. October 25, 2013.http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm372287.htm (accessed2013 Nov 1).

24. Visser E, Schug SA. The role of ketamine in pain management. Biomed Pharmacother.2006; 60:341-8.

25. Weinbroum AA. A single small dose of postoperative ketamine provides rapid and sustainedimprovement in morphine analgesia in the presence of morphine-resistant pain. AnesthAnalg. 2003; 96:789-95.

26. Weinbroum AA. Non-opioid IV adjuvants in the perioperative period: pharmacological andclinical aspects of ketamine and gabapentinoids. Pharmacol Res. 2012; 65:411-29.

27. Yamauchi M, Asano M, Watanabe M et al. Continuous low-dose ketamine improves theanalgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. AnesthAnalg. 2008; 107:1041-4.

Other Useful References

1. Kehlet H, Dahl JB. The value of "multimodal" or "balanced analgesia" in postoperative paintreatment. Anesth Analg. 1993; 77:1048-56.

39


2. Trescot AM, Helm S, Hansen H et al. Opioids in the management of chronic non-cancerpain: an update of American Society of the Interventional Pain Physicians' (ASIPP)Guidelines. Pain Physician. 2008; 11(Suppl 2):S5-S62.

3. U.S. Food and Drug Administration. Goal of label changes: better prescribing, safer use ofopioids. September 10, 2013.http://www.fda.gov/forconsumers/consumerupdates/ucm367660.htm (accessed 2013 Nov1).

40


Julie Golembiewski, Pharm.D., FASHP, Activity Chair Clinical Pharmacist, Anesthesia and Pain University of Illinois Hospital and Health Sciences System Clinical Associate Professor Colleges of Pharmacy and Medicine University of Illinois at Chicago Chicago, Illinois

Julie Golembiewski, Pharm.D., FASHP, is Clinical Pharmacist in Anesthesia and Pain at the University of Illinois Hospital and Health Sciences System (UI Health) in Chicago. She also has a shared appointment in the Departments of Pharmacy Practice and Anesthesiology and a faculty appointment of Clinical Associate Professor at the University of Illinois at Chicago (UIC) Colleges of Pharmacy and Medicine. She serves as co-coordinator for the UIC Department of Anesthesiology Midwest Anesthesia Residents Conference. Dr. Golembiewski teaches pharmacy students and anesthesiology resident physicians, as well as participates in research and committees at UI Health.

Dr. Golembiewski earned her Bachelor of Science in Pharmacy and Doctor of Pharmacy with honors degrees from the UIC College of Pharmacy. She has over 20 years of active pharmacy experience with the majority concentrated in the areas of operating room pharmacy, anesthesiology, and pain management.

Dr. Golembiewski is on the editorial advisory board of Pharmacy Practice News, writes a regular column for the Journal of PeriAnesthesia Nursing, and is a senior editor for LexiComp’s Anesthesiology & Critical Care Drug Handbook. She also co-authored the chapter on perioperative care in the text, Applied Therapeutics: The Clinical Use of Drugs. In addition to these contributions to the literature, Dr. Golembiewski has presented extensively on the topics of operating room pharmacy practice, anesthesia, and pain management.

Dr. Golembiewski is an active member of numerous professional organizations, including the American Society of Health-System Pharmacists (ASHP), American Society for Pain Management Nursing, International Anesthesia Research Society, and Illinois Council of Health-System Pharmacists. She is a fellow of ASHP and received the University of Illinois Class Act Award.

41

Role of Local Anesthetics in Managing Postoperative Pain

Julie Golembiewski, Pharm.D., FASHP

University of Illinois Hospital & Health Sciences System

Chicago, Illinois

Dorsal horn (spinal cord)

Secondary afferentneuron (to brain)

Injury

Pain Perception

Postoperative Pain Mechanisms

Nociceptive - somaticNociceptive - visceralInflammatoryPeripheral and central

sensitizationNeuropathic

General Principles• Most nociceptive impulses originate from the

surgical wound itself

• The surgical wound itself can reinitiate central sensitization

• Skin, muscle, and viscera respond differently to surgical injury • Deep tissue nociceptors sensitize dorsal horn

neurons

• Visceral pain can account for much of the discomfort following certain types of surgery (e.g., laparoscopic)

Lavand’homme P. Eur J Pain Suppl. 2011; 5:357-63.

42

Local Anesthetic Agents

Agent Duration Route of Administration Maximum Dose *

Lidocaine 1 – 3 hr Local infiltration, epidural,tumescent, topical

300 (500)

Bupivacaine 2 – 8 hr Local infiltration, peripheralnerve block, epidural, spinal

175 (225)

Ropivacaine 2 – 8 hr Local infiltration, peripheral nerve block, epidural

225 (225)300 (300)

brachial plexus

Bupivacaine liposome

Up to 72 hr Local infiltration 266

*In milligrams; epinephrine containing solution in parentheses.

Rosenburg PH et al. Reg Anesth Pain Med. 2004; 29:564-75.

Bupivacaine Liposome

• Initial release of bupivacaine HCl followed by slow release of bupivacaine from liposomes to provide analgesia up to 72 hours

• May be diluted with saline (up to 280 mL) to infiltrate all tissue layers along the length of surgical site

The most appropriate analgesic modality following open abdominal surgery is

a. Continuous wound infiltration (bupivacaine)

b. Epidural infusion (bupivacaine + hydromorphone)

c. IV patient-controlled analgesia (morphine)

43

Perioperative Routes of Administration of Local Anesthetics

Topical

Subcutaneous,deep tissue

Transversusabdominal plane

Tumescenttechnique

Intra- orperiarticular

Spinal

Epidural

Intravenous(lidocaine only)

Peripheralnerve block

Local Infiltration

Subcutaneous,deep tissue

Transversusabdominal plane

Tumescenttechnique

Intra- orperiarticular(hip or knee surgery)

Local anesthetic is instilled at or near the site of surgery

Finite area of tissue; no specific nerve or nerve plexus is targeted

Single injection or continuous infusion

Continuous Wound Catheters (Liu et al. 2006)

• 44 RCTs (2,141 subjects)– Cardiothoracic (14 trials), orthopedics (12 trials),

general surgery (11 trials), gyne – urology (7 trials)

– No orthopedic surgery

• Patients with continuous wound catheters– Had significantly decreased pain (at rest and with

activity) and opioid use

– Appeared to have less postoperative nausea/vomiting, shorter length of stay, and increased patient satisfaction

Liu SS et al. J Am Coll Surg. 2006; 203:914-32.

44

Continuous Wound Catheters (Gupta et al. 2011)

• 32 RCTs– Obstetrical and gynecologic surgery

– Major abdominal surgery

– Inguinal herniorrhaphy

– Cardiothoracic surgery

– No orthopedic surgery

• Patients with continuous wound catheters– No significant reduction in pain at rest or with activity,

except OB-gyne surgery

– No significant reduction in opioid consumption exceptfor first 24 hr in OB-gyne surgery

– Magnitude of these effects was smallGupta A et al. Acta Anaesthesiol Scand. 2011; 55:785-96.

Considerations: Continuous Wound Catheters

• Position of catheter– For open nephrectomy, catheter placed

• Superficial to muscle fascia was not effective1

• In pre-peritoneal space was effective2

• Between abdominal wall muscle layers and pre-peritoneum was very effective (“optimal analgesia”)3

– Transverse abdominal plane (TAP)

• Optimal concentration and dose1Fredman B et al. Anesth Analg. 2001; 92:189-93.

2Beaussier M et al. Anesthesiology. 2007; 107:461-8.3Forastiere E et al. Br J Anaesth. 2008; 101:841-7

Kerr DR et al. Acta Orthop. 2008; 79:174-83.

Local Infiltration Analgesia:Orthopedic Surgery (Kerr & Kohan 2008)

• Case series (hip resurfacing arthroplasty, total hip replacement, total knee replacement, N=325)

• MULTIMODAL ANALGESIA– Ropivacaine, ketorolac, epinephrine intra-op

• 150 – 200 mL (“high volume”), “moving needle” injection technique over 1 hr

– Catheter delivered mixture to all joint and tissue planes• “Top up” doses to flood joint if needed

– Reinjection of surgical field 15 – 20 hr post-op

– Scheduled ibuprofen x 24 hr then prn; rescue opioid

– Compression, cooling and splinting of injection site or wound area

45

Local Infiltration Analgesia: Orthopedic Surgery (Kerr & Kohan 2008)

• Results– Satisfactory pain control (pain scores 0 – 3)

– Most able to walk with assistance 5 – 6 hours after surgery

– Most able to walk with independent mobility 13 – 22 hours after surgery

– 71% discharged home after single overnight stay

Kerr DR et al. Acta Orthop. 2008; 79:174-83.

Local Infiltration Analgesia: Orthopedic Surgery (McCarthy & Iohom 2012)

• 10 studies (N = 893)– 8 RCTs, two case series

– Hip resurfacing arthroplasty, total hip replacement, total knee replacement

• Results– 8 studies LIA was an effective analgesic

– 2 studies no benefit when LIA was added to a multimodal analgesic regimen

– LIA efficacy questioned in total hip replacement

McCarthy D et al. Anesthesiol Res Pract. 2012; 2012:709531.

Considerations: LIA, Orthopedic Surgery

• Meticulous infiltration technique and catheter placement– Kerr and Kohan switched to a subcutaneous (posterior to

knee) and an intra-articular (suprapatellar pouch) catheter following total knee replacement

– Not all structures and joints (relevant to pain) are accessible for LIA

• Drugs– Ropivacaine or bupivacaine

• Total dose, total volume

• Large incision with significant exposed tissue, blood vessels and bone raises concern of local anesthetic systemic toxicity

– Addition of ketorolac, epinephrine and/or morphineMcCarthy D et al.Anesthesiol Res Pract. 2012; 2012:709531.

Ganapathy S et al. Anesthesiol Clin. 2011; 29:329-42.

46

Tumescent Infiltration for Liposuction

Tumescenttechnique

Large volumes of very dilute lidocaine and epinephrine infiltrated into subcutaneous tissue

Tissue becomes swollen and firm (“tumescent”), area anesthetized, cannulas placed, liposuction begins

Risk for Systemic Toxicty• Systemic absorption after tumescent

infiltration equivalent to slow infusion (max dose: 35 mg/kg)

• When total dose and infiltration time are held constant, more dilute solution delays systemic absorption

Lidocaine dilution is as important as maximum dose

Klein JA. J Dermatol Surg Oncol. 1990; 16:248-63.Pace MM et al. Plast Reconstr Surg. 2013; 131:820e-6e.

Maximum Recommended Lidocaine Concentration 0.01% - 0.05%

(0.05% = 0.5 mg/mL = 50 mL 1% lidocaine in 1000 mL saline)

Epidural Analgesia

Epidural

Local anesthetic (often with an opioid) infused into epiduralspace for analgesia following thoracic, abdominal, pelvic, or lower extremity surgery

47

Epidural Analgesia

Advantages DisadvantagesBetter analgesia than parenteral opioids Skilled technique

(anesthesiologist)

Better analgesia than IV patient-controlled analgesia (PCA)

Hemodynamic instability

Analgesic agent (local anesthetic + opioid, local anesthetic or opioid alone) does not matter

Motor weakness

Location of catheter does not matter Urinary retention

Spinal hematoma with concurrent anticoagulation

Block BM et al. JAMA. 2003; 290:2455-63.Wu CL et al. Anesthesiology. 2005; 103:1079-88.

Peripheral Nerve Block (Perineural)

Peripheralnerve block

Local anesthetic injected or infused adjacent to a peripheral nerve for analgesia in area innervated by that nerve or nerve plexus

Continuous Peripheral Nerve Block (Perineural Local Anesthetic Infusion)

Advantages DisadvantagesDecreased pain (baseline/breakthrough/dynamic)

Skilled technique (anesthesiologist)

Decreased analgesic requirements Motor weakness (impaired PT, fall risk)

Decreased opioid adverse effects Catheter leak

Decreased sleep disturbances Nerve injury (rare)

Catheter can be removed regardless of thromboprophylaxis

Infection (rare)

PT = physical therapy

Ilfeld BM. Anesth Analg. 2011; 113:904-25.Morfey et al. Anesth Analg. 2011; 113:689-91.

Barreveld A et al. Anesth Analg. 2013; 116:1141-61.

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Considerations: Continuous Peripheral Nerve Block

• Analgesia appears to be better than intra- or periarticular infusions1

– Some effect could be due to systemic distribution

• Total dose (mass) of local anesthetic is more important than volume and concentration2,3

– Ropivacaine 0.1% – 0.2%, 5 – 10 mL/hour +/- patient-controlled boluses

• Doesn’t matter if block is performed pre- or post incision4

• Patient-controlled boluses (vs. continuous infusion) can reduce local anesthetic consumption without affecting analgesia5

1Barreveld A et al. Anesth Analg. 2013; 116:1141-61.2Bertini L et al. Reg Anesth Pain Med. 2009; 34:408-13.

3Chelly JE et al. Br J Anaesth. 2010; 105(Suppl 1):i86-96.4Bunburaphong P et al. J Med Assoc Thai. 2006; 89:462-7.5Eledjam JJ et al. Reg Anesth Pain Med. 2002; 27:604-11.

Transversus Abdominis Plane (TAP) Block

Transversus abdominismuscle

Internal obliquemuscle

Ultrasound probe

Local anesthetic injectionInjection of a

local anesthetic into plane between the internal oblique and transversus abdominis muscles

Transversus Abdominis Plane (TAP) Block• Technique

– Ultrasound-guided

– Direct visualization by surgeon

• Provides analgesia for surgery involving lower abdominal wall– Bowel surgery, appendectomy, cesarean delivery,

hysterectomy, prostatectomy, laparoscopic cholecystectomy

• Single-injection alternative for patients who are not candidates for epidural analgesia or intrathecal morphine

Young MJ et al. Anesthesiol Res Pract. 2012; 2012:731645.Webster K. Update in anaesthesia. 2009. URL in ref list.

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Intravenous Administration (Lidocaine Only)

Intravenous(lidocaine only)

IV Lidocaine• 16 RCTs

– Cholecystectomy, prostatectomy, cystectomy, nephrectomy, colectomy, colorectal, total hip, hysterectomy, hernia, appendectomy, breast surgery

• Bolus, then infusion intra-op and in some studies, up to 24 hours post-op vs. saline

• 13/16 (81%) studies demonstrated improved analgesia with lidocaine infusion

• Consider when epidural or peripheral nerve block not indicated

Barreveld A et al. Anesth Analg. 2013;116:1141-61.

The most appropriate analgesic modality following open abdominal surgery is

a. Continuous wound infiltration (bupivacaine)

b. Epidural infusion (bupivacaine + hydromorphone)

c. IV patient-controlled analgesia (morphine)

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Procedure-Specific Pain Management• Epidural > continuous wound infiltration >> IV PCA1

• PROSPECT for laparoscopic colorectal surgery2

– Local infiltration + IV NSAID + IV acetaminophen + IV PCA (weak opioid when oral); add IV lidocaine if necessary

• Enhances Recovery After Surgery (ERAS®) multimodal perioperative pathway for colorectal surgery3

– Pre-op patient education; fluid management (esophageal Doppler monitoring); early oral nutrition, catheter/drain and mobilization; epidural + acetaminophen + NSAID analgesia, etc.

– Significantly reduced:4

• Length of stay (6 vs. 8.4 days, P<0.001)

• Readmissions (8.8% vs. 20.2%, P=0.012)

• Hospital costs (by 15%)

1Tilleul P et al. Br J Anaesth. 2012; 108:998-1005; 2Joshi GP et al. Colorectal Dis. 2013; 15:146-55;3Enhances Recovery After Surgery (ERAS) Society. ERAS protocol (EP). URL in ref list;

4Miller T et al. Presented at ASA Annual Meeting; October 15, 2013. Abstract A4293.

Adverse Effects and Safety

What is your biggest concern about the safety of local anesthetics?

a. Medication overdose

b. Lack of surgeon expertise

c. Lack of nurse expertise

d. Lack of pharmacist expertise

e. None – these drugs are very safe

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Maximum Recommended Dose• Although not necessarily evidence-based, maximum dose

highlights “dose” as a risk factor for systemic toxicity

• Large, deep surgical incisions and dissections with muscle and vascular exposure may increase systemic absorption1

• “…because drug concentrations in various regions of heart and brain tissue differ quite markedly, the deterministic notion of a “toxic” or “lethal” blood or tissue concentration of local anesthetic appears invalid even with standardized conditions”2

1Bianconi M et al. Br J Anaesth. 2003; 91:830-5.2Copeland SE et al. Anesth Analg 2008; 106:1440-9.

Local Anesthetic Systemic Toxicity (LAST)

• Blood levels influenced by site of injection and dose

• Other factors that can increase likelihood of LAST– Advanced age

– Heart failure, ischemic heart disease, conduction abnormalities

– Metabolic (e.g., mitochondrial) disease

– Liver disease or low plasma protein concentration

– Metabolic or respiratory acidosis

– Medications that inhibit sodium channels

• Patients with severe cardiac dysfunction, particularly low ejection fraction– More sensitive to LAST

– Prone to ‘stacked’ injections (due to slowed circulation time) with resulting elevated tissue concentrations

Neal JM et al. Reg Anesth Pain Med. 2012; 37:16-8.Neal JM et al. Reg Anesth Pain Med. 2010; 35:152-61.

LAST (continued)

• Central nervous system signs (metallic taste, circumoral numbness, altered mental status) may be subtle or absent

• Cardiovascular signs may be only manifestation

• More than one third of reports of toxicity involved patients with underlying cardiac, neurologic, renal, hepatic, pulmonary, or metabolic disease– Dose reduction and heightened vigilance may be warranted

• Treatment– Airway management

– Seizure suppression – avoid propofol

– Advanced cardiac life support

– Lipid rescue (20% lipids)

Neal JM et al. Reg Anesth Pain Med 2010; 35:152-61.Rosenberg PH et al. Reg Anesth Pain Med. 2004; 29:564-75.

Weinberg G. LipidRescue Resuscitation for drug toxicity. URL in ref list.

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Safety Considerations• Intraoperative documentation and communication

– Medications administered by surgeon and/or anesthesia care provider may not flow to medication administration record

– Administration by two different providers (anesthesiologist surgeon) without knowledge or discussion

• “Other formulations of bupivacaine should not be administered within 96 hours following administration of Exparel” (bupivacaine liposome injectable suspension)*

• Monitoring

• Drug interactions (CYP3A4)

• Availability of lipid rescue

*Exparel (bupivacaine liposome injectable suspension) prescribing information. Pacira Pharmaceuticals, Inc; 2011 Oct.

Conclusion• Different types of surgery have different types of

structures relevant for postoperative pain; structures may or may not be accessible for local anesthetic– Direct visualization or ultrasound guided

– Systematic approach to determine optimal injection technique, drug, and dose

• Local anesthetics– An important component of multimodal perioperative

analgesia

– Safe when appropriate measures are taken to minimize the risk of systemic toxicity

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Selected References

1. Barreveld A, Witte J, Chahal H et al. Preventive analgesia by local anesthetics: the reduction of postoperative pain by peripheral nerve blocks and intravenous drugs. Anesth Analg. 2013; 116:1141-61.

2. Beaussier M, El’Ayoubi H, Schiffer E et al. Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study. Anesthesiology. 2007; 107:461-8.

3. Bertini L, Palmisani S, Mancini S et al. Does local anesthetic dilution influence the clinical effectiveness of multiple-injection axillary brachial plexus block?: a prospective, double-blind, randomized clinical trial in patients undergoing upper limb surgery. Reg Anesth Pain Med. 2009; 34:408-13.

4. Bianconi M, Ferraro L, Traina GC et al. Pharmacokinetics and efficacy of ropivacaine continuous wound instillation after joint replacement surgery. Br J Anaesth. 2003; 91:830-5.

5. Block BM, Liu SS, Rowlingson AJ et al. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003; 290:2455-63.

6. Bunburaphong P, Niruthisard S, Werawatganon T et al. Postoperative analgesia for total knee replacement: comparing between pre-and postoperative "3-in-1" femoral nerve block. J Med Assoc Thai. 2006; 89:462-7.

7. Chelly JE, Ghisi D, Fanelli A. Continuous peripheral nerve blocks in acute pain management. Br J Anaesth. 2010; 105(Suppl 1):i86-96.

8. Copeland SE, Ladd LA, Gu XQ et al. The effects of general anesthesia on whole body and regional pharmacokinetics of local anesthetics at toxic doses. Anesth Analg. 2008; 106:1440-9.

9. Eledjam JJ, Cuvillon P, Capdevila X et al. Postoperative analgesia by femoral nerve block with ropivacaine 0.2% after major knee surgery: continuous versus patient-controlled techniques. Reg Anesth Pain Med. 2002; 27:604-11.

10. Enhances Recovery After Surgery (ERAS) Society. ERAS protocol (EP). http://www.erassociety.org/index.php/eras-care-system/eras-protocol (accessed 2013 Oct 30).

11. Exparel (bupivacaine liposome injectable suspension) prescribing information. San Diego, CA: Pacira Pharmaceuticals, Inc.; 2011 Oct.

12. Forastiere E, Sofra M, Giannarelli D et al. Effectiveness of continuous wound infusion of 0.5% ropivacaine by On-Q pain relief system for postoperative pain management after open nephrectomy. Br J Anaesth. 2008; 101:841-7.

13. Fredman B, Zohar E, Tarabykin A et al. Bupivacaine wound instillation via an electronic patient-controlled analgesia device and a double-catheter system does not decrease postoperative pain or opioid requirements after major abdominal surgery. Anesth Analg. 2001; 92:189-93.

14. Ganapathy S, Brookes J, Bourne R. Local infiltration analgesia. Anesthesiol Clin. 2011; 29:329-42.

15. Gupta A, Favaios S, Perniola A et al. A meta-analysis of the efficacy of wound catheters for post-operative pain management. Acta Anaesthesiol Scand. 2011; 55:785-96.

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16. Ilfeld BM. Continuous peripheral nerve blocks: a review of the published evidence. Anesth Analg. 2011; 113:904-25.

17. Joshi GP, Bonnet F, Kehlet H et al. Evidence-based postoperative pain management after laparoscopic colorectal surgery. Colorectal Dis. 2013; 15:146-55.

18. Kerr DR, Kohan L. Local infiltration analgesia: a technique for the control of acute postoperative pain following knee and hip surgery: a case study of 325 patients. Acta Orthop. 2008; 79:174-83.

19. Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol. 1990; 16:248-63.

20. Lavand’homme P. Improving postoperative pain management: continuous wound infusion and postoperative pain. Eur J Pain Suppl. 2011; 5:357-63.

21. Liu SS, Richman JM, Thirlby RC et al. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006; 203:914-32.

22. McCarthy D, Iohom G. Local infiltration analgesia for postoperative pain control following total hip arthroplasty: a systematic review. Anesthesiol Res Pract. 2012; 2012:709531. http://www.hindawi.com/journals/arp/2012/709531/ (accessed 2013 Oct 29).

23. Miller T, Ernst FR, Krukas MR et al. Postoperative outcomes associated with Enhanced Recovery After Surgery (ERAS) protocol compliance. Presented at the American Society of Anesthesiologists Annual Meeting. San Francisco, CA: October 15, 2013. Abstract A4293. http://www.asaabstracts.com/strands/asaabstracts/abstract.htm;jsessionid=C8ACE378C060A11BA980F025F60550BA?year=2013&index=14&absnum=4971 (accessed 2013 Oct 30).

24. Morfey DH, Chan VW, Brull R. Tripping over perineural catheters. Anesth Analg. 2011; 113:689-91.

25. Neal JM, Mulroy MF, Weinberg GL et al. American Society of Regional Anesthesia and Pain Medicine checklist for managing local anesthetic systemic toxicity: 2012 version. Reg Anesth Pain Med. 2012; 37:16-8.

26. Neal JM, Bernards CM, Butterworth JF 4th et al. ASRA practice advisory on local anesthetic systemic toxicity. Reg Anesth Pain Med. 2010; 35:152-61.

27. Pace MM, Chatterjee A, Merrill DG et al. Local anesthetics in liposuction: considerations for new practice advisory guidelines to improve patient safety. Plast Reconstr Surg. 2013; 131:820e-6e.

28. Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004; 29:564-75.

29. Thornton PC, Buggy DJ. Local anaesthetic wound infusion for acute postoperative pain: a viable option? Br J Anaesth. 2011; 107:656-8.

30. Tilleul P, Aissou M, Bocquet F et al. Cost-effectiveness analysis comparing epidural, patient-controlled intravenous morphine, and continuous wound infiltration for postoperative pain management after open abdominal surgery. Br J Anaesth. 2012; 108:998-1005.

31. Webster K. The transversus abdominis plane (TAP) block: abdominal plane regional anaesthesia. Update in anaesthesia. 2009. http://update.anaesthesiologists.org/wp-content/uploads/2009/10/Transversus-Abdominis-Plane-TAP-Block.pdf (accessed 2013 Oct 29).

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32. Weinberg G. LipidRescue resuscitation for drug toxicity. http://www.lipidrescue.org/ (accessed 2013 Oct 29).

33. Wu CL, Cohen SR, Richman JM et al. Efficacy of postoperative patient-controlled and continuous infusion epidural analgesia versus intravenous patient-controlled analgesia with opioids: a meta-analysis. Anesthesiology. 2005; 103:1079-88.

34. Young MJ, Gorlin AW, Modest VE et al. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012; 2012:731645.

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Self–assessment Questions

1. ABC Hospital is reviewing its policies related to the use of high-risk medication devices inmanaging postoperative pain. As a way to build safe practice around the use of thesedevices, use of intrathecal, epidural, and nerve blocks should be restricted to

a. Anesthesia care providers and certified specialists.b. Pharmacists and surgeons.c. Pharmacists and anesthesia care providers.d. Surgeons and certified specialists.

2. ABC Hospital should use which of the following techniques for prospective identification ofproblems before implementing an analgesic delivery device?

a. Value analysis.b. Weighted decision matrix.c. Failure mode and effects analysis.d. Survey of health care provider satisfaction.

3. Which of the following is a peripheral regional technique included in the 2012 practiceguidelines of the American Society of Anesthesiologists for acute pain management in theperioperative setting?

a. Local anesthetic infiltration of incision.b. Intramuscular injection.c. Epidural opioids.d. Systemic opioid patient controlled analgesia (PCA).

4. Cardiothoracic surgeons at XYZ Health System have been providing pain managementusing a prescriber-specific, opioid-driven approach with opioids prescribed as needed (PRN)immediately postoperative, followed by acetaminophen and opioid combination productsPRN. The surgeons seek input about how to improve postoperative pain management.Which of the following best reflects the group that should be included in the discussion?

a. Team of pharmacists and cardiothoracic surgeons.b. Team of pharmacists, nurses, cardiothoracic surgeons, anesthesiologists, and

hospital administration policy makers.c. Staff of XYZ’s existing pain service and cardiothoracic surgeons.d. No team needed, rely on expertise of chief cardiothoracic surgeon.

5. Which of the following recommendations would be most appropriate to improve painmanagement for patients having cardiothoracic surgery at XYZ Health System?

a. Order PCA morphine, then long-acting opioids around the clock.b. Order PCA morphine followed by short-acting opioids PRN.c. Add multimodal non-opioid therapy around the clock.d. Continue current opioid-driven approach.

6. Which of the following types of local infiltration of local anesthetic agents is a single-injectionalternative for patients who are undergoing major abdominal surgery?

a. Peripheral nerve block.b. Tumescent infiltration.c. Continuous wound catheter.d. Transversus abdominis plane block.

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7. Which of the following patient characteristics can increase the risk of developing local anesthetic systemic toxicity?

a. Young age. b. Male gender. c. Severe cardiac dysfunction. d. Metabolic alkalosis.

Answers

1. a

2. c

3. a

4. b

5. c

6. d

7. c

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