Multimodal Perioperative Pain Management
- Conditions
- Degenerative Spondylolisthesis
- Interventions
- Drug: Local anaesthesia
- Registration Number
- NCT01513564
- Lead Sponsor
- Northern Orthopaedic Division, Denmark
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Degenerative disc disease and Spondylolisthesis up to grade 2 at one to the three lower lumbar levels.
- Previous fusion, metabolic bone disease, severe comorbidity or psychological instability.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Conservative treatment program Postoperative epidural morphine 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. Conservative treatment program Local anaesthesia 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.
- Primary Outcome Measures
Name Time Method Multimodal management of lumbar fusion Two years Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index
- Secondary Outcome Measures
Name Time Method Multimodal management of lumbar fusion 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.
Trial Locations
- Locations (1)
Orthopaedic Research Unit, Aarhus University, Aalborg Hospital
🇩🇰Aalborg, Denmark