A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

• Status: Recruiting
• Trial end date: 2024-02-05
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study was to determine if cannabinoid use decreases narcotic consumption in patients undergoing total knee arthroplasty (TKA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colorado Joint Replacement
• Treatments: Dronabinol

Criteria

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