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

NCT ID: NCT01053039

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-02-28

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.

Detailed Description

Adult patients (>18 yrs or older) undergoing instrumented fusion for degenerative lumbar spine disease will be recruited and randomized to receive one of two treatments. The first group will receive an injection of morphine (200mcg) into the intrathecal space at the time of the operation. The second group will receive a saline injection. The pharmacy will prepare the aforementioned injections and deliver them to the operating room to ensure all parties are blinded. Both groups will then have a standardized analgesic regimen (including PCA morphine and parenteral analgesics) available to them in the post-operative period. Each group will be followed at regular intervals post-operatively. At each follow-up, visual analogue pain scores, side effects and narcotic use will be assessed. Patients will also have a daily functional assessment which will dictate the time of discharge. Hospital stay will be measured from time of admission to time where patient no longer requires acute hospital care based on the functional assessment.

Conditions

Acute Pain Following Decompressive Lumbar Spinal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intrathecal Morphine

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

Group Type: ACTIVE_COMPARATOR

Intrathecal Morphine

Intervention Type: DRUG

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

Intrathecal Saline

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

Group Type: PLACEBO_COMPARATOR

Intrathecal Saline

Intervention Type: DRUG

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

Interventions

Intrathecal Morphine

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

Intervention Type: DRUG

Intrathecal Saline

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

Intervention Type: DRUG

Other Intervention Names

Epimorph

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Dr. Stephan du Plessis

Clinical Assistant Professor, Department of Clinical Neurosciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan J du Plessis, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Chairman, University of Calgary Spine Program

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

22518

Identifier Type: -

Identifier Source: org_study_id