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A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users Versus Cannabis Naïve Inflammatory Bowel Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04055662
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Brief Summary:
Cannabis is a drug that is widely used for recreational purpose. In most patients undergoing surgery, opioids are the most widely used mode of pain relief, during and following surgery. Anecdotally it has been observed that cannabis users required unexpectedly high doses of opioids. The purpose of this study is to compare opioid requirements between cannabis users and non- users after the surgery. Currently, post-operative opioid doses are determined based on various patient factors such as pre-operative opioid use, patient weight, age and sensitivity to opioids during surgery. Patients' requirements may be underestimated and opioid regimens need to be escalated in the first 24 hours in order to alleviate uncontrolled pain in cannabis users. Better understanding of the impacts of cannabis use on post-operative opioid requirements would help the Acute Pain Service optimize post-operative pain management for patients who use cannabis pre-operatively.

Condition or disease
Cannabis Use, Opioid Consumption

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Cannabis users
Cannabis naive

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 2 years ]
    Amount of morphine equivalents on PCA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Elective IBD bowel surgery under general anesthesia

Inclusion Criteria:

  1. Consent to participate and signed consent form.
  2. Age: 18-65 years.
  3. Elective IBD bowel surgery under general anesthesia.
  4. PCA use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04055662

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Contact: Zeev Friedman 4165865270

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Canada, Ontario
Sinai Health System Recruiting
Toronto, Ontario, Canada, M5G1X2
Contact: Zeev Friedman    4165865270   
Sponsors and Collaborators
Mount Sinai Hospital, Canada

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Responsible Party: Mount Sinai Hospital, Canada Identifier: NCT04055662     History of Changes
Other Study ID Numbers: 2108.2.7
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders