Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2001-01-31
2006-06-30
Brief Summary
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The objective is to evaluate the effect of a revised and optimized perioperative fast track program in lumbar fusion surgery.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SINGLE
Study Groups
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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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Aarhus University Hospital
OTHER
Copenhagen University Hospital, Denmark
OTHER
Northern Orthopaedic Division, Denmark
OTHER
Responsible Party
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Principal Investigators
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Sten Rasmussen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
David S. Krum-Moeller, M.D.
Role: STUDY_CHAIR
Department of Orthopaedic Surgery, Vejle and Give Hospital
Lene R. Lauridsen
Role: STUDY_CHAIR
Department of Orthopaedic Surgery, Vejle and Give Hospital
Henrik Kehlet, M.D.
Role: STUDY_CHAIR
Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
Locations
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Orthopaedic Research Unit, Aarhus University, Aalborg Hospital
Aalborg, , Denmark
Countries
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Other Identifiers
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ON-07-008-RAS
Identifier Type: -
Identifier Source: org_study_id
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