Clinical trial NCT01513564: Multimodal Perioperative Pain Management
Official title: Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Spondylolisthesis
Keywords: Disc disease
Spondylolisthesis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Aarhus University Hospital
name: Copenhagen University Hospital, Denmark
First posted: 2012-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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.

Primary outcomes:
measure: Multimodal management of lumbar fusion
timeFrame: Two years
Secondary outcomes:
measure: Multimodal management of lumbar fusion
timeFrame: Two years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Research Unit, Aarhus University, Aalborg Hospital
Study officials:
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
name: David S. Krum-Moeller, M.D.
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery, Vejle and Give Hospital
name: Lene R. Lauridsen
role: STUDY_CHAIR
affiliation: Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
name: Henrik Kehlet, M.D.
role: STUDY_CHAIR
References: