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Multimodal Perioperative Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01513564
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : May 28, 2015
Vejle Hospital
Aarhus University Hospital
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

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.

Condition or disease Intervention/treatment Phase
Degenerative Spondylolisthesis Drug: Postoperative epidural morphine Drug: Local anaesthesia Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Multimodal Perioperative Pain Management of Circumferential Lumbar Fusion Improves Recovery
Study Start Date : January 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

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 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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01513564

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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
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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

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Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01513564     History of Changes
Other Study ID Numbers: ON-07-008-RAS
First Posted: January 20, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Northern Orthopaedic Division, Denmark:
Disc disease
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents