- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055662
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
Conditions
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:
- Consent to participate and signed consent form.
- Age: 18-65 years.
- Elective IBD bowel surgery under general anesthesia.
- 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.
Sponsor
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
Additional Relevant MeSH Terms
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.
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