RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty

Quick Facts

Study Start:2020-02-05

Study Completion:2025-02-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04298528

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Rose Johnson

CONTACT

3032602940

roseannjohnson@centura.org

Principal Investigator

Jason M Jennings, MD DPT

PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Study Locations (Sites)

Colorado Joint Replacement

Denver, Colorado, 80210

United States

Collaborators and Investigators

Sponsor: Colorado Joint Replacement

Jason M Jennings, MD DPT, PRINCIPAL_INVESTIGATOR, Colorado Joint Replacement

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-05

Study Completion Date2025-02-05

Study Record Updates

Study Start Date2020-02-05

Study Completion Date2025-02-05

Terms related to this study

Additional Relevant MeSH Terms

Osteoarthritis, Knee