Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery

July 27, 2023 updated by: University of Alberta
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: 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).
Within 24 hours post-operatively

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vivian Ip, MBChB, Staff Anesthesiologist

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00102596

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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