MedTrace Logo

Multimodal Perioperative Pain Management

NCT01513564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-05-28

No results posted yet for this study

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.

Conditions

  • Degenerative Spondylolisthesis

Interventions

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.

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.

Sponsors & Collaborators

  • Vejle Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Copenhagen University Hospital, Denmark

    collaborator OTHER

  • Northern Orthopaedic Division, Denmark

    lead OTHER

Principal Investigators

  • Sten Rasmussen, M.D. · Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark

  • David S. Krum-Moeller, M.D. · Department of Orthopaedic Surgery, Vejle and Give Hospital

  • Lene R. Lauridsen · Department of Orthopaedic Surgery, Vejle and Give Hospital

  • Henrik Kehlet, M.D. · Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen

Study Design

Allocation
NA
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2003-12-31
Completion
2006-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513564 on ClinicalTrials.gov