Acute Pain Following Decompressive Lumbar Spinal Surgery Clinical Trial
— ITMPOfficial title:
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
Verified date | December 2015 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | Yes |