Multimodal Perioperative Pain Management

Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Spondylolisthesis
• Intervention / Treatment: Drug: Postoperative epidural morphine; Drug: Local anaesthesia

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Orthopaedic Research Unit, Aarhus University, Aalborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: Convalescence after lumbar fusion; Drug: 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.; Other Names: Convalescence after lumbar fusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multimodal management of lumbar fusion	Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Northern Orthopaedic Division, Denmark
• Collaborators: Aarhus University Hospital; Vejle Hospital; Copenhagen University Hospital, Denmark
• Investigators: Principal Investigator: Sten Rasmussen, M.D., Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark; Study Chair: David S. Krum-Moeller, M.D., Department of Orthopaedic Surgery, Vejle and Give Hospital; Study Chair: Lene R. Lauridsen, Department of Orthopaedic Surgery, Vejle and Give Hospital; Study Chair: Henrik Kehlet, M.D., Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: December 13, 2011
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 20, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Spondylolisthesis; Disc disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: ON-07-008-RAS