The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Pain Following Decompressive Lumbar Spinal Surgery
Intervention: Intrathecal Morphine (Drug); Intrathecal Saline (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Calgary Official(s) and/or principal investigator(s): Stephan J du Plessis, MD, FRCSC, Principal Investigator, Affiliation: Chairman, University of Calgary Spine Program
Overall contact: Tara L Whittaker, BN, Phone: 403-944-8528, Email: sri@ucalgary.ca
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.
Clinical Details
Official title: The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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: Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tara L Whittaker, BN, Phone: 403-944-8528, Email: sri@ucalgary.ca
Foothills Medical Centre, Calgary, Alberta T2N 2T9, Canada; Recruiting Stephan J du Plessis, MD, FRCSC, Phone: 403-944-4776, Email: sjdp@inbox.com Tara L Whittaker, BN, Phone: 403-944-8528, Email: sri@ucalgary.ca
Additional Information
Starting date: January 2010
Last updated: November 5, 2010
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