Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery

NCT04587700 | Completed

• 1 other identifier: Pro00102596
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Marijuana use has increased since its legalization in Canada and many believe that it may help patients that are experiencing chronic pain. The investigators want to assess if patients who have used marijuana chronically will need more medication to control their pain after they have undergone orthopedic trauma surgery (ex. Hip, femur, humerus fractures etc.). In this study, the investigators will identify chronic marijuana users (ie. those using for 3 months or more) who are undergoing orthopedic trauma surgery to assess how much pain medication they need post-operatively and compare this with non-users. The investigators will also evaluate their pain scores, pain medication use and other complications that they may have during or after their surgeries, including any nausea/vomiting, heart or breathing problems.

Conditions

Cannabis; Marijuana

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  The total opioid consumption (morphine equivalents) at 24 hours post-operatively in chronic marijuana users compared to the control group (no marijuana).

  Within 24 hours post-operatively

Study Arms (2)

Non-marijuana user

Has never consumed marijuana or has abstained for at least the past 12 months

Chronic Marijuana User

Has used marijuana in any form at least once a week for the past 3 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient recruits will be identified by accessing the electronic health record at the University of Alberta hospital (Edmonton, Alberta, Canada) and the written slate available at the Royal Alexandra hospital (Edmonton, Alberta, Canada). These sources will list the elective orthopedic slate, accessible about 1 week prior to surgery, and the trauma slate which is available at least 24 hours prior to surgery. Patients can also be identified in the pre-assessment clinic. Research supervisors and designated assistants will be responsible for identifying potential participants. Once their location is identified, the research assistant will consent the patient at least 12 hours prior to surgery or in the pre-assessment clinic where patients will attend at least 24 hours prior to surgery.

You may qualify if:

• Adults ranging from age 18-75 years old
• Patients undergoing orthopedic trauma surgery
• Patients who consent to the study
• ASA class I to III

You may not qualify if:

• Patient refusal
• Patients lacking capacity to consent
• Intraoperative regional anesthesia technique
• Chronic pain patient

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Vivian Ip, MBChB

  Staff Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: September 21, 2020
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CA (1)