Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Multimodal Perioperative Pain Management

This study has been completed.
Sponsor:
Collaborators:
Vejle Hospital
Aarhus University Hospital
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01513564
First received: December 13, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Degenerative Spondylolisthesis
Drug: Postoperative epidural morphine
Drug: Local anaesthesia

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery

Resource links provided by NLM:


Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Multimodal management of lumbar fusion [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Back and leg pain on VAS, neurological deficits, hospital stay, bony fusion and Oswestry Disability Index


Secondary Outcome Measures:
  • Multimodal management of lumbar fusion [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Assessment of the effects of at fast track program with ongoing epidural analgesia, multimodal pain treatment including ketorolac and early intensive mobilization and physiotherapy.


Enrollment: 120
Study Start Date: January 2001
Study Completion Date: June 2006
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Convalescence after lumbar fusion.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513564

Locations
Denmark
Orthopaedic Research Unit, Aarhus University, Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Vejle Hospital
Aarhus University 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
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01513564     History of Changes
Other Study ID Numbers: ON-07-008-RAS
Study First Received: December 13, 2011
Last Updated: September 12, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Northern Orthopaedic Division, Denmark:
Disc disease
Spondylolisthesis

Additional relevant MeSH terms:
Spondylolisthesis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis
Spondylosis
Anesthetics
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014