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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
  Purpose

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.


Condition Intervention Phase
Acute Pain Following Decompressive Lumbar Spinal Surgery
Drug: Intrathecal Morphine
Drug: Intrathecal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

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. [ Time Frame: Pre-op to discharge ] [ Designated as safety issue: No ]

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. [ Time Frame: Pre-op to discharge ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: January 2010
Study Completion Date: February 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053039

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Stephan J du Plessis, MD, FRCSC Chairman, University of Calgary Spine Program
  More Information

Responsible Party: Dr. Stephan du Plessis, Clinical Assistant Professor, Department of Clinical Neurosciences, University of Calgary
ClinicalTrials.gov Identifier: NCT01053039     History of Changes
Other Study ID Numbers: 22518 
Study First Received: January 19, 2010
Last Updated: December 15, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 27, 2016