Degenerative Spondylolisthesis
Conditions
Keywords
Disc disease, Spondylolisthesis
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
Interventions
DRUGPostoperative 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.
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.
Sponsors
Vejle Hospital
Aarhus University Hospital
Copenhagen University Hospital, Denmark
Northern Orthopaedic Division, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multimodal management of lumbar fusion | Two years | Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed