1. Malignant Pain The 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. 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 OpiatesSpinal Opiates/Drugs Decreased LOCPruritis DepressionPedal Edema Respiratory Depression Decreased Gag Reflex Pulmonary Aspiration Decreased Appetite Nausea & Vomiting Constipation Immune Suppression Decreased Libido

11. Intrathecal Drugs Mostly Off-Label Uses ApprovedCommonly Used MorphineHydromorphone ZiconitideFentanyl BaclofenSufentanyl 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 MedstreamMedtronic 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 – Diameter76.0 mm 20 ccThickness21.6 mmWeight150 gm 40 ccThickness28.2 mmWeight155 gm Medtronic Synchromed II Pump – Diameter87.5 mm 20 ccThickness19.5 mmWeight165 gm 40 ccThickness26.0 mmWeight 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 FieldRotor 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 PainNot the best practice. Side EffectsPreferred 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 04/08/08Initial Consultation – Pain Primarily in Pelvis 04/10/08Epidural Trial Placement 04/17/08Permanent 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 03/02/09Hospitalized with abdominal pain – Pump Increased

39. Case Study 03/02/09Hospitalized with abdominal pain – Pump Increased 03/03/09 AMSymptoms worsen – Decreased Appetite – Nausea and Vomiting – Low Grade Fever

40. Case Study 03/02/09Hospitalized with abdominal pain – Pump Increased 03/03/09 AMSymptoms worsen – Decreased Appetite – Nausea and Vomiting – Low Grade Fever 03/03/09 PMDx: Intraabdominal Process – CAT Scan of Abdomen – Surgical Consultation – Sigmoid Colectomy

41. Case Study 03/02/09Hospitalized with abdominal pain – Pump Increased 03/03/09 AMSymptoms worsen – Decreased Appetite – Nausea and Vomiting – Low Grade Fever 03/03/09 PMDx: Intraabdominal Process – CAT Scan of Abdomen – Surgical Consultation – Sigmoid Colectomy 03/08/09Discharged in good condition