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The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery

NCT01053039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-12-16

No results posted yet for this study

Summary

The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.

Based on our literature review, we expect a significant improvement in pain scores and functional status and minimal side effects with the use of intrathecal morphine. With improved pain and function we would also expect shorter hospital stays in those patients receiving intrathecal morphine.

Conditions

  • Acute Pain Following Decompressive Lumbar Spinal Surgery

Interventions

DRUG

Intrathecal Morphine

Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.

DRUG

Intrathecal Saline

The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Stephan J du Plessis, MD, FRCSC · Chairman, University of Calgary Spine Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-11-30
Completion
2015-02-28

Countries

  • Canada

Study Locations

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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 NCT01053039 on ClinicalTrials.gov