Pain Treatment Ladder. Indications for Neurostimulation and Intrathecal Drug Delivery Therapy

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1 Max Wirjo,MD,FRCPC,DABA Director, Integrated Pain Medicine The Permanente Medical Group Kaiser Fresno Medical Center,California,USA Pain Treatment Ladder Indications for Neurostimulation and Intrathecal Drug Delivery Therapy Device therapies are now considered earlier in the treatment continuum Neurostimulation Radiculopathies Neuralgias Neurostimulation or Intrathecal Drug Delivery Therapy FBSS Complex regional pain syndrome Arachnoiditis Intrathecal Drug Delivery Therapy Diffuse cancer pain Axial somatic pain Stamatos JM, et al. Live Your Life Pain Free, October Based on the interventional pain management experience of Dr. John Stamatos Medtronic, Inc Baker RM, Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg 362. Refer full prescribing information for Medtronic Neurostimulation Systems and Synchromed II and Isomed Drug Infusion Systems

2 Patient Selection Considerations Patients who have neuropathic pain in a concordant anatomic distribution respond best to neurostimulation (NS) therapy Patients who have nociceptive pain in a concordant distribution respond best to Intrathecal Drug Delivery (IDD) Patients who do not respond well to NS may be candidates for IDD therapy Intrathecal Drug Delivery Therapy IDD therapy involves the delivery of pain medicine in the intrathecal space The pump is connected to a thin, flexible catheter and all of this is implanted under the skin Smaller doses of medication are needed for effective pain relief because drug is delivered directly to the pain receptors Cole AJ. In Low Back Pain Handbook, 2Medtronic, nd ed. 2003; Inc. pg Synchromed II Drug Infusion System Indications Chronic intrathecal infusion of preservative free morphine sulfate sterile solution in the treatment of chronic intractable pain Also indicated for chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative free morphine sulfate sterile solution in the treatment of chronic intractable pain, and chronic intrathecal infusion of preservative free ziconotide sterile solution for the management of severe chronic pain Benefits of IDD Therapy Pain relief for patients who have not received adequate relief from conventional therapies 1 Reduction in adverse effects from oral opioids such as nausea, vomiting, sedation and constipation 1 Decreased oral analgesic requirements 2 Increased ability to perform activities of daily living 2 May be effective for patients who do not experience relief from neurostimulation therapy 3 Lioresal is a registered trademark of Novartis Medtronic, Pharmaceuticals, Inc Inc. 1. Lamer TJ: Mayo Clin Proc.1994 May;69(5): Review. 2. Paice JA, et al: J Pain Symptom Manage.1996;11(2): Kumar K, et al. Surg Neurol 2001;55:79 88.

3 Risks of IDD Therapy Inflammatory mass formation Catheter or procedural complications Overdose due to programming or drug concentration error respiratory depression, loss of consciousness, reversible coma, and in extreme cases, may be life threatening Surgical complications, such as infection Drug withdrawal due to pump malfunction Side effects associated with IT morphine including: Diminished libido GI effects (nausea, vomiting, constipation) Pruritis Confusion Peripheral edema Mortality rate associated with Intrathecal Opioid therapy for Non Cancer pain 0.088% within 3 days, 0.39 % at 1 month and 3.89% at 1 year (after initiation or reinitiation of intrathecal opioid therapy), higher than SCS implantation or Lumbar discectomy in community hospitals. These rates were 7.5, 3.4 and 2.7 times higher, respectively, at each interval than expected based on the age and gender matched general US population. Refer to prescribing information for the SynchroMed II Infusion System for further details regarding risk of IDD therapy Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85: Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2): Coffey et al, Anesthesiology 2009, 111; Do we need to change our practice/treatment consideration? Consider SCS and PNS on almost all type of Non Cancer pain before Intrathecal Opioid treatment Should we regionalized this type of treatment in our organization? Should we standardize the staffing requirement and education? Communication within our organization? Should we get involved nationally (Registry)? Coffey et al, Pain Med 2010; 11(7);

4 Microdosing in Intrathecal Opioid therapy Emerging concept and practice? To prevent Opioid induced hyperalgesia Detoxify patient from all mu agonists until opioid free, then maintain this state for 6 weeks Trial with intrathecal morphine 0.2 mgm or less ( 0.05 mgm) Proceed with pump implant and start the initially with the lowest dose possible Most benefit in elderly patient There are a Number of Proposed Benefits Associated with Microdosing: May reduce potential for drug interaction or accidental overdose because opioids are delivered in much smaller intrathecal increments May decrease risk of respiratory depression due to the low opioid dosage May reduce potential for dose related adverse effects including lower extremity edema, hypogonadism May reduce opioid induced hyperalgesia so there may be little or no need for repeated escalation Clinical Observations that Suggest the Development of Hyperalgesia When objective tests have ruled out disease progression: Pain persists or increases with increased opioid dosage Pain increases on a constant opioid dosage Pain is worse on opioids than prior to opioids Duration of analgesia decreases with duration of therapy Pain becomes increasingly diffuse anatomically and less well defined in character with duration of therapy Hyperalgesia apparent opioid tolerance is not synonymous with pharmacological tolerance, which calls for opioid dose escalation, but may be the first sign of opioidinduced pain sensitivity suggesting a need for opioid dose reduction. repeated opioid administration could lead to a progressive and lasting reduction of baseline nociceptive thresholds, hence an increase in pain sensitivity. Mao, Pain,, 100 (2002)

5 New Consideration When Considering Algorithms for Implantable Devices SCS should always be considered in the patient with neuropathic pain prior to placing a pump SCS should always be considered as an alternative to intrathecal drug delivery for visceral pain syndrome when appropriate PNS should be considered at an adjuvant to SCS when the latter therapy gives a partial but incomplete coverage,this may allow Rx w/o the need of pump IDD(with new precaution) should be considered in the algorithm when SCS w or w/o PNS fails or is not appropriate Neurostimulation Therapy Delivers small electrical signals to the epidural space Inhibits pain signals before they reach the brain and replaces them with a tingling sensation that covers the specific areas where pain was felt Indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain Deer T,Pain Med 2010:11(7);987-9 Medtronic, Inc Spinal Cord Stimulator Peripheral Nerve Stimulation(PNS)is a neuromodulation technique in which electrical current is applied to the peripheral nerves to ameliorate chronic pain. Subcutaneous Peripheral Nerve Stimulation (SPNS) is a variant of PNS in which the electrodes are placed in the subcutaneous space directly adjacent to the region of pain.the electrode stimulate the small, unnamed cutaneous peripheral nerve and not larger, named peripheral nerves.

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