A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty
- Registration Number
- NCT04298528
- Lead Sponsor
- Colorado Joint Replacement
- Brief Summary
The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).
- Detailed Description
Subjects enrolled will be randomized into one of two groups either receiving the study drug or a placebo and will be followed for the first 6 weeks with regards to outcomes data.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 460
Inclusion Criteria
- Provision of signed and dated informed consent from
- Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
- Male or Female
- Age 21-75
- Unilateral total knee arthroplasty at Colorado Joint Replacement
- All individuals will be screened for drug use (including cannabis) at their preoperative appointment
- Ability to take oral medication and be willing to adhere to the dronabinol regimen
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria
- Narcotic use in the past 6 weeks
- Regular cannabis use in the past 3 months
- Major depression or anxiety disorders
- Documented psychiatric illness (e.g. bipolar, schizophrenia)
- Seizure disorder
- Current or previous history of drug and alcohol abuse
- Known allergic reactions to components of dronabinol
- Tobacco use in the past 90 days
- Treatment with another investigational drug
- Patients that cannot receive spinal anesthesia
- Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)
- Patients that are not able to go home after leaving the hospital and require a short term rehabilitation facility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol. dronabinol Dronabinol Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.
- Primary Outcome Measures
Name Time Method Morphine Equivalence 30 day's post operative Morphine Equivalence of pain medication used after a total knee replacement
- Secondary Outcome Measures
Name Time Method Defense and Veterans Pain Scale 30 day's post operative Patients will keep a pain log after their joint replacement on a scale of 0 - 10
The Pittsburgh Sleep Quality Index 4 weeks and 6 weeks post operative To monitor sleeping habits
The Veterans Rand 12-Item Health Survey 6 weeks post operative Patient reported outcome
Nausea 30 day's post operative Patients post operative nausea will be collected as none/mild/moderate/severe
KOOS-12 Knee Survey 6 weeks post operative Patient reported outcome
Knee Society Score 4 weeks post operative Patient reported outcome
Trial Locations
- Locations (1)
Colorado Joint Replacement
🇺🇸Denver, Colorado, United States