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Clinical Trials/NCT01513564
NCT01513564
Completed
N/A

Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

Northern Orthopaedic Division, Denmark1 site in 1 country120 target enrollmentJanuary 2001

Overview

Phase
N/A
Intervention
Postoperative epidural morphine
Conditions
Degenerative Spondylolisthesis
Sponsor
Northern Orthopaedic Division, Denmark
Enrollment
120
Locations
1
Primary Endpoint
Multimodal management of lumbar fusion
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2001
End Date
June 2006
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Northern Orthopaedic Division, Denmark
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Postoperative epidural morphine

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.

Intervention: Local anaesthesia

Outcomes

Primary Outcomes

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 Outcomes

  • Multimodal management of lumbar fusion(Two years)

Study Sites (1)

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