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

The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain Following Decompressive Lumbar Spinal Surgery
• Intervention / Treatment: Drug: Intrathecal Morphine; Drug: Intrathecal Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrathecal Morphine; Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.	Drug: Intrathecal Morphine; Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.; Other Names: Epimorph
Placebo Comparator: Intrathecal Saline; The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.	Drug: Intrathecal Saline; The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Stephan J du Plessis, MD, FRCSC, Chairman, University of Calgary Spine Program

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 21, 2010

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 22518

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No