Clinical trial NCT01053039: The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery
Official title: The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain Following Decompressive Lumbar Spinal Surgery
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
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.
timeFrame: Pre-op to discharge
Secondary outcomes:
measure: Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.
timeFrame: Pre-op to discharge
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: Chairman, University of Calgary Spine Program
name: Stephan J du Plessis, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: