Multimodal Perioperative Pain Management
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|ClinicalTrials.gov Identifier: NCT01513564|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Spondylolisthesis||Drug: Postoperative epidural morphine Drug: Local anaesthesia||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||December 2003|
|Actual Study Completion Date :||June 2006|
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.
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.
Other Name: Convalescence after lumbar fusion
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.
Other Name: Convalescence after lumbar fusion.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513564
|Orthopaedic Research Unit, Aarhus University, Aalborg Hospital|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Sten Rasmussen, M.D.||Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark|
|Study Chair:||David S. Krum-Moeller, M.D.||Department of Orthopaedic Surgery, Vejle and Give Hospital|
|Study Chair:||Lene R. Lauridsen||Department of Orthopaedic Surgery, Vejle and Give Hospital|
|Study Chair:||Henrik Kehlet, M.D.||Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen|