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

NCT01053039 | Completed Phase 4 DMC

• 1 other identifier: 22518
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for lumbar spinal stenosis.

  Pre-op to discharge

Secondary Outcomes (1)

• Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.

  Pre-op to discharge

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

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

Drug: Intrathecal Morphine

Intrathecal Saline

PLACEBO COMPARATOR

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

Drug: Intrathecal Saline

Interventions

Intrathecal Morphine DRUG

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

Also known as: Epimorph

Intrathecal Morphine

Intrathecal Saline DRUG

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

Intrathecal Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18yrs or older
• elective surgery for instrumented fusion of the lumbar spine for stenosis (\< 5 levels)
• with back and/or leg pain
• patients who meet ASA class 1 or 2

You may not qualify if:

• Patients unable to speak english
• known allergies to morphine or other opioids
• spinal surgery other than lumbar spine surgery
• history of severe respiratory illness including COPD and asthma
• history of obstructive sleep apnea
• pregnancy
• lumbar procedures performed in minimally invasive fashion
• patients lacking mental capacity to use PCA
• patients on sustained release narcotics
• patients undergoing revision of previous instrumented lumbar spine surgery
• patients with psychiatric disorders.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Study Officials

• Stephan J du Plessis, MD, FRCSC

  Chairman, University of Calgary Spine Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Clinical Neurosciences

Study Record Dates

• First Submitted: January 19, 2010
• First Posted: January 21, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)