The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery (ITMP)
Primary Purpose
Acute Pain Following Decompressive Lumbar Spinal Surgery
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Intrathecal Morphine
Intrathecal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain Following Decompressive Lumbar Spinal Surgery
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.
Sites / Locations
- Foothills Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intrathecal Morphine
Intrathecal Saline
Arm Description
Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Full Information
NCT ID
NCT01053039
First Posted
January 19, 2010
Last Updated
December 15, 2015
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT01053039
Brief Title
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
Acronym
ITMP
Official Title
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain Following Decompressive Lumbar Spinal Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal Morphine
Arm Type
Active Comparator
Arm Description
Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
Arm Title
Intrathecal Saline
Arm Type
Placebo Comparator
Arm Description
The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Morphine
Other Intervention Name(s)
Epimorph
Intervention Description
Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
Intervention Type
Drug
Intervention Name(s)
Intrathecal Saline
Intervention Description
The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
Primary Outcome Measure Information:
Title
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.
Time Frame
Pre-op to discharge
Secondary Outcome Measure Information:
Title
Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
Time Frame
Pre-op to discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan J du Plessis, MD, FRCSC
Organizational Affiliation
Chairman, University of Calgary Spine Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
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