Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04587700 |
| Other study ID # |
Pro00102596 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2020 |
| Est. completion date |
July 5, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
