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Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Failed Back Surgery Syndrome

Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Failed Back Surgery Syndrome. Michael Hanes, M.D., I. Elias Veizi, M.D., Ph.D., Connie Wang, Salim Hayek, M.D., Ph.D. Division of Pain Medicine Department of Anesthesiology. Intrathecal Drug Delivery.

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Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Failed Back Surgery Syndrome

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  1. Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Failed Back Surgery Syndrome Michael Hanes, M.D., I. Elias Veizi, M.D., Ph.D., Connie Wang, Salim Hayek, M.D., Ph.D. Division of Pain Medicine Department of Anesthesiology

  2. Intrathecal Drug Delivery • Failed back surgery syndrome (FBSS) • Most common non-cancer indication for IDDS • Localized pain • Mixed pain = neuropathic + nociceptive • Hydromorphone and bupivacaine = PACC 2nd line therapy • Raphael, JH. et al (2002) BMC Musculoskeletal Dis 3(17). • Deer, TR. et al (2010) Neuromodulation Sep 15(5)13(3): 436-466.

  3. 2012 Polyanalgesic Algorithm for Intrathecal Therapies in Nociceptive Pain Line 1: Morphine and ziconotide are approved by the US Food and Drug Administration for IT therapy and are recommended as first-line therapy for nociceptive pain. Hydromorphone is recommended on the basis of widespread clinical use and apparent safety. Fentanyl has been upgraded to first-line use by the consensus conference. Line 2: Bupivacaine in combination with morphine, hydromorphone, or fentanyl is recommended. Alternatively, the combination of ziconotide and an opioid drug can be employed. Line 3: Recommendations include clonidine plus an opioid (ie, morphine, hydromorphone, or fentanyl) or sufentanil monotherapy. Line 4: The triple combination of an opioid, clonidine, and bupivacaine is recommended. An alternate recommendation is sufentanil in combination with either bupivacaine or clonidine. Line 5: The triple combination of sufentanil, bupivacaine, and clonidine is suggested. Deer TR et al., Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel. Neuromodulation. 2012 Sep;15(5):436-466

  4. 2012 Polyanalgesic Algorithm for Intrathecal Therapies in Neuropathic pain Line 1: Morphine and ziconotide are approved by the US Food and Drug Administration for IT therapy and are recommended as first-line therapy for neuropathic pain. The combination of morphine and bupivacaine is recommended for neuropathic pain on the basis of clinical use and apparent safety. Line 2: Hydromorphone, alone or in combination with bupivacaine or clonidine is recommended. Alternatively, the combination of morphine and clonidine may be used. Line 3: Third-line recommendations for neuropathic pain include clonidine, ziconotide plus an opioid, and fentanyl alone or in combination with bupivacaine or clonidine. Line 4: The combination of bupivacaine and clonidine (with or without an opioid drug) is recommended. Line 5: Baclofen is recommended on the basis of safety, although reports of efficacy are limited. Deer TR et al., Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel. Neuromodulation. 2012 Sep;15(5):436-466

  5. Bernards CM. Curr Opin in Anaesth 2004, 17:441–447 Bupivacaine Diffusion Veizi IE, et al. (2011) Pain Medicine 12:1481-89.

  6. Study Objective • Purpose: Examine the efficacy of IT coadministration of hydromorphone and bupivacaine from the outset of IT therapy and up to 24 months after implantation of IDDS.

  7. Study Population • Retrospective review • 38 FBSS patients • 2007 – 2011 • Followed for up to 2 years

  8. Intrathecal Pump Implantation • Stepwise multidisciplinary treatment approach. • 24-48 hr in-patient trial with continuous IT infusion • Hydromorphone ~10 mcg/ml + bupivacaine 0.625 mg/ml • 0.2 ml/hr  • >50% pain relief • Implantation • Hydromorphone + bupivacaine • Titrated for pain relief and AE • Personal therapy manager (PTM) • Set to deliver hydromorphone + bupivacaine (0.5-1.2 mg) per bolus

  9. Results Pain Intensity Data presented as mean (line) ± SEM (whiskers) * Denotes significant difference from time 0. Oral Opioid Consumption

  10. Intrathecal Dose Escalation • Hydromorphone r2 = 0.9939 • Bupivacaine r2 = 0.3371

  11. Intrathecal Hydromorphone Dose Escalation Veizi IE, et al. (2011) Pain Medicine 12:1481-89. • r2 = 0.7202 • Slope = 13.93 • r2 = 0.969 • Slope (O+B) = 14.58

  12. Conclusion • IT hydromorphone and bupivacaine effective for FBSS. • Improved pain intensity • Reduction in oral opioid consumption • Decreased IT opioid dose escalation

  13. THANK YOU!

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