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

Acute Pain Following Decompressive Lumbar Spinal Surgery Clinical Trial

— ITMP  

Official title:

The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053039
• Other study ID #: 22518
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: December 15, 2015
• Start date: January 2010
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Following Decompressive Lumbar Spinal Surgery

Intervention

Drug:
• Intrathecal Morphine
Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.
• Intrathecal Saline
The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

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