Multimodal Perioperative Pain Management

Degenerative Spondylolisthesis Clinical Trial

Official title:

Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513564
• Other study ID #: ON-07-008-RAS
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: May 27, 2015
• Start date: January 2001
• Est. completion date: June 2006

Study information

• Verified date: May 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2006
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis
• Spondylolisthesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Orthopaedic Research Unit, Aarhus University, Aalborg Hospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark	Aarhus University Hospital, Copenhagen University Hospital, Denmark, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multimodal management of lumbar fusion	Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index	Two years	No
Secondary	Multimodal management of lumbar fusion	Assessment of the effects of at fast track program with ongoing epidural analgesia, multimodal pain treatment including ketorolac and early intensive mobilization and physiotherapy.	Two years	No