Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT04587700
Collaborator
(none)
80
1
27.3
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Since its legalization in Canada, marijuana consumption has become more common while also being the most widely used illicit drug within the USA. In addition to being consumed recreationally, cannabis is being increasingly prescribed by medical practitioners as nearly 15% of Canadian and Australian patients experiencing chronic pain use it as one component of treatment. Recent evidence has demonstrated that specific patient cohorts may benefit from cannabis, including those with fibromyalgia, diabetic neuropathy, complex regional pain syndrome, multiple sclerosis, traumatic neuropathic pain, and difficulty sleeping due to chronic pain, amongst others. Cannabis contains two main components: delta-9-tetrahydrocannabinol (THC), which is active, and cannabidiol, which is inactive. THC has its effects by binding to Type 1 cannabinoid receptors and inhibiting pain pathways while activation of Type 2 cannabinoid receptors have anti-inflammatory properties.

    As literature continues to investigate its analgesic characteristics, many proponents of cannabis use believe that it can modify pain response in various settings. One such setting that is of special interest for pain control is during the post-operative period. Currently, there is minimal data available to reflect the analgesic requirement, and thus degree of pain, for a patient who is a chronic marijuana user immediately following a surgical procedure. A class of surgical procedures that is of particular interest to us due to its pain-evoking characteristics is orthopedic trauma surgery. In fact, orthopedic surgeons are one of the higher opioid prescribing specialists, potentially highlighting the difficulty in achieving adequate pain control in their patient population. More information is required to better tailor analgesia for these patients as it may contribute towards their overall recovery, restoring mobility, and patient satisfaction (6,7).

    Through this study, the investigators would like to investigate the relationship between orthopedic trauma surgery and post-operative pain control in the chronic marijuana user. Minimal data is available in the literature reflecting this potentially common situation. Specifically, the investigators are interested in the clinical implications of marijuana use on opioid consumption and verbal pain rating in this patient scenario. The investigators also hope that the data can reflect possible side effects or other concerning outcomes in the peri-operative period so that clinicians may be able to provide more personalized care to these patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery
    Actual Study Start Date :
    Sep 21, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Total opioid consumption [Within 24 hours post-operatively]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adults ranging from age 18-75 years old

    • Patients undergoing orthopedic trauma surgery

    • Patients who consent to the study

    • ASA class I to III

    Exclusion Criteria:
    • Patient refusal

    • Patients lacking capacity to consent

    • Intraoperative regional anesthesia technique

    • Chronic pain patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alberta Edmonton Alberta Canada T6G 2R3

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    • Principal Investigator: Vivian Ip, MBChB, Staff Anesthesiologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT04587700
    Other Study ID Numbers:
    • Pro00102596
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022