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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Stephan du Plessis, University of Calgary
ClinicalTrials.gov Identifier:
NCT01053039
First received: January 19, 2010
Last updated: December 15, 2015
Last verified: December 2015

January 19, 2010
December 15, 2015
January 2010
November 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053039 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
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The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Pain Following Decompressive Lumbar Spinal Surgery
  • Drug: Intrathecal Morphine
    Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
    Other Name: Epimorph
  • Drug: Intrathecal Saline
    The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
  • Active Comparator: Intrathecal Morphine
    Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
    Intervention: Drug: Intrathecal Morphine
  • Placebo Comparator: Intrathecal Saline
    The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.
    Intervention: Drug: Intrathecal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2015
November 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01053039
22518
Yes
Not Provided
Not Provided
Dr. Stephan du Plessis, University of Calgary
University of Calgary
Not Provided
Principal Investigator: Stephan J du Plessis, MD, FRCSC Chairman, University of Calgary Spine Program
University of Calgary
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP