Malignant PainThe Role of IDDS

Mark Schlesinger, MDSchlesinger Pain Centerswww.schlespain.com

Malignant Pain

When I graduated from medical school over 30 years ago, I never promised to cure anyone, but I did promise to relieve pain and allay suffering.

What is Malignant Pain?

What is Malignant Pain?• Pain caused by the cancer itself

What is Malignant Pain?• Pain caused by the cancer itself• What will not be discussed?

What is Malignant Pain?• Pain caused by the cancer itself• What will not be discussed?• Post-Surgical Pain• Radiation Neuritis• Post-Chemotherapy Pain• Pain in Cancer Survivors

Pain Sub Types• Nociceptive Pain– Bone Metastases

• Neuropathic Pain– Nerve Root Invasion– Spinal Cord Invasion– Brachial or Lumbar Plexus Invasion

• Visceral Pain– Pancreatic Cancer Involving Celiac Plexus

What is IDDS?

• Intrathecal Drug Delivery Systems• Direct Administration of Drugs to Spinal Cord• Fully Implantable Therapies• Programmable vs. Non-Programmable

Why IDDS?

• Potency– Multiple Spinal Receptors• Opiate Receptors• Sodium Channels• Calcium Channels• Adrenergic Receptors• NMDA Receptors

Why IDDS?

• Side EffectsSystemic Opiates Spinal Opiates/Drugs

Decreased LOC PruritisDepression

Pedal EdemaRespiratory DepressionDecreased Gag ReflexPulmonary AspirationDecreased AppetiteNausea & VomitingConstipationImmune SuppressionDecreased Libido

Intrathecal Drugs• Mostly Off-Label Uses

Approved Commonly UsedMorphine HydromorphoneZiconitide FentanylBaclofen Sufentanyl

BupivacaineRopivacaineClonidineKetamine

Not used: Demerol due to side effects & drug interactions

Intrathecal Drug Mixtures

Double, double toil and trouble;Fire burn and cauldron bubble.

Intrathecal Drug Mixtures

Non-Programmable Pumps

• Codman 3000– Three Sizes• 16 cc, 30 cc & 50 cc

– Fixed Flow Rates• 16 cc size, 4 models delivering 0.3-1.3 cc per day• 30 cc size, 4 models delivering 0.3-1.7 cc per day• 50 cc size, 3 models delivering 0.5-3.4 cc per day

– Dose Controlled Changing Drug Concentration

Programmable Pumps

• Codman Medstream Medtronic Synchromed II

Programmable Pumps

• Codman Medstream– Pump Type: Gas Driven Piston Pump– Service Life: 8 years– Minimum Flow Rate: 0.10 cc per day

• Medtronic Synchromed II– Pump Type: Gas Driven Roller Pump– Service Life: 7 years– Minimum Flow Rate: 0.05 cc per day

Programmable Pumps

• Codman Medstream Pump– Diameter 76.0 mm• 20 cc Thickness 21.6 mm Weight

150 gm• 40 cc Thickness 28.2 mm Weight

155 gm

• Medtronic Synchromed II Pump– Diameter 87.5 mm• 20 cc Thickness 19.5 mm Weight

165 gm• 40 cc Thickness 26.0 mm Weight

175 gm

Programmable Pumps

• Codman Medstream Pump– MRI Compatibility• Certified to 3 Tesla• Effect of Magnetic Field ?

• Medtronic Synchromed II Pump– MRI Compatibility• Certified to 3 Tesla• Effect of Magnetic Field Rotor Lock-Up,

Restarts

Programmable Pumps

• Medtronic Synchromed II Pump– Programming Modes• Simple Continuous – for baseline pain• Bolus Delivery – for sudden adjustments• Flex Mode – Multiple Programmable Steps• PTM – Intrathecal PCA, with all the bells & whistles

– Therapy modeled after intravenous & epidural PCA– Advantages

» Better Pain Control» Lower Total Dose of Medication» Fewer Side Effects

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.Continuous Infusion – the normal rate of infusion of the drug. This determines the

steady state level of the drug and thereby the effectiveness of therapy.

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.Continuous Infusion – the normal rate of infusion of the drug. This determines the

steady state level of the drug and thereby the effectiveness of therapy.PCA Dose – the patient controlled analgesia dose. This is the amount that the patient

can administer at any one time.

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.Continuous Infusion – the normal rate of infusion of the drug. This determines the

steady state level of the drug and thereby the effectiveness of therapy.PCA Dose – the patient controlled analgesia dose. This is the amount that the patient

can administer at any one time.Lockout Interval – the minimum time between allowable PCA doses. The larger the

lockout interval the lower the risk of overdose and the higher the risk of underdose.

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.Continuous Infusion – the normal rate of infusion of the drug. This determines the

steady state level of the drug and thereby the effectiveness of therapy.PCA Dose – the patient controlled analgesia dose. This is the amount that the patient

can administer at any one time.Lockout Interval – the minimum time between allowable PCA doses. The larger the

lockout interval the lower the risk of overdose and the higher the risk of underdose.

Maximum Daily PCA Dose – the maximum number of times that the patient can give themselves a PCA dose. Again the lower the maximum dose, the lower the risk of overdose, but the higher the risk of underdose.

PCA BasicsBolus – an instantaneous injection of drug to suddenly initiate therapy or to increase

steady state levels.Continuous Infusion – the normal rate of infusion of the drug. This determines the

steady state level of the drug and thereby the effectiveness of therapy.PCA Dose – the patient controlled analgesia dose. This is the amount that the patient

can administer at any one time.Lockout Interval – the minimum time between allowable PCA doses. The larger the

lockout interval the lower the risk of overdose and the higher the risk of underdose.

Maximum Daily PCA Dose – the maximum number of times that the patient can give themselves a PCA dose. Again the lower the maximum dose, the lower the risk of overdose, but the higher the risk of underdose.

Maximum Periodic PCA Dose – this allows the physician to set the maximum number of doses for a 2, 4, 8 or 12 hour period. This is most useful to allow a greater number of daytime as opposed to nighttime injections.

Who Is A Candidate?

• Pain Syndromes at or below clavicle• Nociceptive, Neuropathic or Visceral Pain• Life Expectancy at least 3-6 months• Unrelieved Pain Not the best practice.• Side Effects Preferred

reason!– Usually at the level of Oxycontin 60mg per day

Epidural Trial

• Office Procedure• Catheters placed within 24 hours• Trials up to 2 weeks long

Final Implantation

Day Surgery ProcedureLumbar Needle EntryCatheter Tip: Cervical, Thoracic or LumbarPump in R or L Buttock

Follow Up Care

• Initial Care– Everyday for 2-3 days– Twice a week for two weeks– Every month or so thereafter

• Long Term – Dozens of Patients– Hundreds of Syringes

• Shifts in Pain Patterns

Case Study

• PB 48 YO W male presents in 2000

Case Study

Radical Prostatectomy

RadiationChemotherapyHormone Manipulation

Case Study

2006

Case Study

2007

Case Study

• 04/08/08 Initial Consultation– Pain Primarily in Pelvis

• 04/10/08 Epidural Trial Placement• 04/17/08 Permanent Implantation– Morphine 0.7 mg per day c good relief of pain

Case Study

• Summer 2008– Increased pain despite increased morphine dose– Add Bupivacaine

Case Study

• Summer 2008– Increased pain despite increased morphine dose– Add Bupivacaine

• Fall 2008– Increased pain despite increased combined dose– Add Clonidine

Case Study

• Summer 2008– Increased pain despite increased morphine dose– Add Bupivacaine

• Fall 2008– Increased pain despite increased combined dose– Add Clonidine

• Christmas 2008– Therapy Failing– Increased pain despite increased combined dose– Pain Shifting to legs– Add Ziconitide

Case Study

• 03/02/09 Hospitalized with abdominal pain– Pump Increased

Case Study

• 03/02/09 Hospitalized with abdominal pain– Pump Increased

• 03/03/09 AM Symptoms worsen– Decreased Appetite– Nausea and Vomiting– Low Grade Fever

Case Study

• 03/02/09 Hospitalized with abdominal pain– Pump Increased

• 03/03/09 AM Symptoms worsen– Decreased Appetite– Nausea and Vomiting– Low Grade Fever

• 03/03/09 PM Dx: Intraabdominal Process– CAT Scan of Abdomen– Surgical Consultation– Sigmoid Colectomy

Case Study

• 03/02/09 Hospitalized with abdominal pain– Pump Increased

• 03/03/09 AM Symptoms worsen– Decreased Appetite– Nausea and Vomiting– Low Grade Fever

• 03/03/09 PM Dx: Intraabdominal Process– CAT Scan of Abdomen– Surgical Consultation– Sigmoid Colectomy

• 03/08/09 Discharged in good condition