Dronabinol in Total Knee Arthroplasty (TKA)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Opioid Use
- Total Knee Arthroplasty
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Masking Description: Throughout cannabinoid research, there has been concern about potential unblinding due to the side effect profile of this class of medication. Prior meta-analyses have advocated for the use of active placebo, with concern that unblinding may misrepresent the effects of clinical trials. However, due to evidence of histamine receptor involvement in pain transmission, as well as overlap in antihistamine antiemetic use and common cannabinoid side effect profiles, we have chosen to use non-active placebo. Our hope is to elicit maximum benefit of cannabinoid dosing perioperatively without confounding variables. With use of non-active placebo, we will perform a comprehensive blinding analysis following the study period to ensure adequate blinding.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04734080
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kethy Jules-Elysee, M.D. Hospital for Special Surgery, New York
Get Well Soon