Skip to main content
OpenTrials
Completed

NCT Number: NCT01513564

Multimodal Perioperative Pain Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Spondylolisthesis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Research Unit, Aarhus University, Aalborg Hospital

Aalborg, 9000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Postoperative epidural morphine

Drug

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 names: Convalescence after lumbar fusion

Local anaesthesia

Drug

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 names: Convalescence after lumbar fusion.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Collaborators

  • Aarhus University Hospital
  • Copenhagen University Hospital, Denmark
  • Vejle Hospital

Registry information

Official study title

Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

Important dates

Study start
2001
Primary completion
2003
Study completion
2006
First posted
Jan 20, 2012
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.