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

April 7, 2022 updated by: Mount Sinai Hospital, Canada

A Comparison of Post-Operative Analgesia Requirements In Recreational Cannabis Users

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G1X2
        • Sinai Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elective IBD bowel surgery under general anesthesia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cannabis users
Cannabis naive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 2 years
Amount of morphine equivalents on PCA
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ACTUAL)

March 30, 2020

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2108.2.7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cannabis Use, Opioid Consumption

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