title: Intrathecal Hydromorphone and Bupivacaine Combination Therapy for Post-Laminectomy Syndrome Optimized with Patient-Activated Bolus Device.
abstract: Intrathecal (IT) pumps have become a valuable tool in managing intractable non-cancer pain. The purpose of this study was to evaluate the efficacy of using a rigorous treatment algorithm for trialing and implanting IT pumps with hydromorphone and bupivacaine in managing a more homogeneous population of post-laminectomy syndrome or failed back surgery syndrome (FBSS) patients.
  
  
  
  This is a retrospective analysis of FBSS patients with chronic intractable back pain implanted with IT pumps delivering hydromorphone and bupivacaine.
  
  
  
  A cohort of 57 (26 males, 31 females) consecutively implanted FBSS patients was analyzed. The average age at implant was 65.4 years. Average pain scores were 8.4 ± 0.2 (pre-implant), 4.9 ± 0.4 (6 months), 5.2 ± 0.5 (12 months), and 4.3 ± 0.5 (24 months). Average oral opioid doses in morphine equivalents were 56 ± 10 mg/day (pre-implant), 12.0 ± 3.5 mg/day (12 months), 15 ± 6 mg/day (24 months). Average IT hydromorphone doses were 79 ± 6.8 mcg/day (at implant), 184 ± 22 mcg/day (6 months), 329 ± 48 mcg/day (12 months), and 487 ± 80 mcg (24 months). IT hydromorphone dose escalation from baseline was 133% (6 months vs baseline), 78% (12 months vs 6 months), and 48% from 12 months to 24 months. Average IT bupivacaine doses were 5.8 ± 0.3 mg/day (implant), 9.5 ± 0.6 mg/day (6 months), 12.2 ± 0.7 mg/day (12 months), and 12.6 ± 0.9 mg/day (24 months).
  
  
  
  IT hydromorphone and bupivacaine are effective in treating chronic pain of FBSS, as demonstrated by the reduction of pain intensity and oral opioid consumption. However, an IT dose escalation phenomenon was observed, although at a reduced rate compared with what had been previously reported in the literature. It is possible that the local anesthetic combination delivered via a patient-activaed bolus device is an important factor. Despite demonstrating effectiveness, the clinical utility of myPTM-optimized IT therapy remains limited by a lack of prospective, placebo-controlled trials and comparative effectiveness research.
authors.affiliation: *Department of Anesthesiology, Division of Pain Medicine, University Hospitals Case Medical Center, Cleveland, Ohio Salim.hayek@uhhospitals.org.|Department of Anesthesiology, Case Western Reserve University, Cleveland, Ohio.
authors.forename: Salim M
authors.initials: SM
authors.lastname: Hayek
authors.affiliation: Department of Anesthesiology, Case Western Reserve University, Cleveland, Ohio.|Department of Anesthesiology, Pain Medicine and Spine Care, Louis Stokes Veterans Administration Medical Center, Cleveland, Ohio, USA.
authors.forename: Elias
authors.initials: E
authors.lastname: Veizi
authors.affiliation: *Department of Anesthesiology, Division of Pain Medicine, University Hospitals Case Medical Center, Cleveland, Ohio.
authors.forename: Michael
authors.initials: M
authors.lastname: Hanes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016058:Analgesia, Patient-Controlled / Q000379:methods*; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D002045:Bupivacaine / Q000008:administration & dosage*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D055111:Failed Back Surgery Syndrome / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage*; D007278:Injections, Spinal; D007796:Laminectomy / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D012189:Retrospective Studies
chemical_list: D000701:Analgesics, Opioid; D004091:Hydromorphone; D002045:Bupivacaine
keywords: Chronic Pain; Failed Back Surgery Syndrome; Intrathecal Drug Delivery System; Intrathecal Granuloma; Intrathecal Pump; Post-Laminectomy Syndrome;  Intrathecal Therapy