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Completed

NCT Number: NCT01053039

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal morphine

Drug

Treatment group to receive 0.2mg of intrathecal morphine followed by PCA morphine.

Other names: Epimorph

Intrathecal Saline

Drug

The control group will receive intrathecal saline followed by PCA. All patients will receive a standardized postoperative regimen.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: ITMP

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jan 21, 2010
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.