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Multimodal Perioperative Pain Management

N

Northern Orthopaedic Division, Denmark

Status

Completed

Conditions

Degenerative Spondylolisthesis

Treatments

Drug: Postoperative epidural morphine
Drug: Local anaesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT01513564
ON-07-008-RAS

Details and patient eligibility

About

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.

Full 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

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

Conservative treatment program
Experimental group
Description:
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.
Treatment:
Drug: Local anaesthesia
Drug: Postoperative epidural morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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