CannabisNCT04587700
Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery
An observational study of Cannabis and Marijuana, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2020to 5 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults ranging from age 18-75 years old
- Patients undergoing orthopedic trauma surgery
- Patients who consent to the study
- ASA class I to III
Who cannot join
- Patient refusal
- Patients lacking capacity to consent
- Intraoperative regional anesthesia technique
- Chronic pain patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start21 Sep 2020
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian Ip, MBChB, Principal investigator, Staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587700
- Sponsor's protocol ID
- Pro00102596
- Status last verified
- Jul 2023
- First submitted
- 7 Oct 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery
- ClinicalTrials.gov ID
- NCT04587700
- Acronym / sponsor ID
- Pro00102596
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Adults ranging from age 18-75 years old
- Patients undergoing orthopedic trauma surgery
- Patients who consent to the study
- ASA class I to III
Key exclusion criteria (4 listed)
- Patient refusal
- Patients lacking capacity to consent
- Intraoperative regional anesthesia technique
- Chronic pain patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Ip, MBChB principal investigator
Staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis and Marijuana, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: Within 24 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.