Multimodal Perioperative Pain Management

Overview

Convalescence after lumbar fusion is dependent on pain. In orthopaedic and abdominal surgery accelerated stay programs with optimized pain management enhance recovery. The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.

Full Title of Study: “Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2003

Detailed Description

Major spine surgery is usually associated with high postoperative pain scores and opioid requirements. Epidural analgesia has been reported to be an effective and safe method to control postoperative pain after spinal instrumentation surgery, but the overall effects of pain management on postoperative length of stay and recovery remains debatable. However, in a multimodal approach, including multimodal non-opioid analgesia to control postoperative pathophysiology and rehabilitation, complications and hospital stay have been reduced after arthroscopy, hip arthroplasty and knee arthroplasty, hip fractures and abdominal surgery and other procedures, when combined with an enhanced recovery program. The aim of the study is to assess the effect and safety of a combined analgesic regimen consisting of local anesthetic, intra-operative and post-operative continuous epidural analgesia and a single dose ketorolac together with a fast track rehabilitation program after 360 degree lumbar fusion for degenerative disc disease and spondylolisthesis < 2

Interventions

  • Drug: Postoperative epidural morphine
    • The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.
  • Drug: Local anaesthesia
    • Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.

Arms, Groups and Cohorts

  • Experimental: Conservative treatment program
    • The control group were supervised isometric passive and active exercises by a physiotherapist. On the second day patients were allowed to sit in a chair being instructed to a low intensity exercise training program with regard to back pain and fear of activity. From the third or fourth day stair training, low intensity exercise, daily walks and instruction in home training were allowed. The intervention group received the same training program but with a faster program plus a higher intensity exercise-training program.

Clinical Trial Outcome Measures

Primary Measures

  • Multimodal management of lumbar fusion
    • Time Frame: Two years
    • Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index

Secondary Measures

  • Multimodal management of lumbar fusion
    • Time Frame: Two years
    • Assessment of the effects of at fast track program with ongoing epidural analgesia, multimodal pain treatment including ketorolac and early intensive mobilization and physiotherapy.

Participating in This Clinical Trial

Inclusion Criteria

  • Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels. Exclusion Criteria:

  • Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northern Orthopaedic Division, Denmark
  • Collaborator
    • Vejle Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sten Rasmussen, M.D., Principal Investigator, Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
    • David S. Krum-Moeller, M.D., Study Chair, Department of Orthopaedic Surgery, Vejle and Give Hospital
    • Lene R. Lauridsen, Study Chair, Department of Orthopaedic Surgery, Vejle and Give Hospital
    • Henrik Kehlet, M.D., Study Chair, Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen

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