Malignant Pain The Role of IDDS

1. Malignant PainThe Role of IDDS Mark Schlesinger, MD Schlesinger Pain Centers www.schlespain.com

2. 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.

3. What is Malignant Pain?

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

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

6. 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

7. 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

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

9. Why IDDS? • Potency • Multiple Spinal Receptors • Opiate Receptors • Sodium Channels • Calcium Channels • Adrenergic Receptors • NMDA Receptors

10. Why IDDS? • Side Effects Systemic Opiates Spinal Opiates/Drugs Decreased LOC Pruritis Depression Pedal Edema Respiratory Depression Decreased Gag Reflex Pulmonary Aspiration Decreased Appetite Nausea & Vomiting Constipation Immune Suppression Decreased Libido

11. Intrathecal Drugs • Mostly Off-Label Uses Approved Commonly Used Morphine Hydromorphone Ziconitide Fentanyl Baclofen Sufentanyl Bupivacaine Ropivacaine Clonidine Ketamine Not used: Demerol due to side effects & drug interactions

12. Intrathecal Drug Mixtures Double, double toil and trouble; Fire burn and cauldron bubble.

13. Intrathecal Drug Mixtures

14. 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

15. Programmable Pumps • Codman Medstream Medtronic Synchromed II

16. 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

17. 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

18. 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

19. 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

20. PCA Basics Bolus – an instantaneous injection of drug to suddenly initiate therapy or to increase steady state levels.

21. PCA Basics Bolus – 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.

22. PCA Basics Bolus – 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.

23. PCA Basics Bolus – 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.

24. PCA Basics Bolus – 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.

25. PCA Basics Bolus – 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.

26. 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

27. Epidural Trial • Office Procedure • Catheters placed within 24 hours • Trials up to 2 weeks long

28. Final Implantation Day Surgery Procedure Lumbar Needle Entry Catheter Tip: Cervical, Thoracic or Lumbar Pump in R or L Buttock

29. 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

30. Case Study • PB 48 YO W male presents in 2000

31. Case Study Radical Prostatectomy Radiation Chemotherapy Hormone Manipulation

32. Case Study 2006

33. Case Study 2007

34. 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

35. Case Study • Summer 2008 • Increased pain despite increased morphine dose • Add Bupivacaine

36. Case Study • Summer 2008 • Increased pain despite increased morphine dose • Add Bupivacaine • Fall 2008 • Increased pain despite increased combined dose • Add Clonidine

37. 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

38. Case Study • 03/02/09 Hospitalized with abdominal pain • Pump Increased

39. 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

40. 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

41. 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