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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04055662
Other study ID # 2108.2.7
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date March 30, 2020

Study information

Verified date August 2019
Source Mount Sinai Hospital, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Sinai Health System Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid consumption Amount of morphine equivalents on PCA 2 years