Clinical trial NCT04298528: A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty
Official title: A Prospective, Randomized, Double Blind Trial Comparing Dronabinol to a Placebo in the Management of Post-operative Pain in Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 460
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Morphine Equivalence
timeFrame: 30 day's post operative
Secondary outcomes:
measure: Nausea
timeFrame: 30 day's post operative
measure: Defense and Veterans Pain Scale
timeFrame: 30 day's post operative
measure: The Pittsburgh Sleep Quality Index
timeFrame: 4 weeks and 6 weeks post operative
measure: Knee Society Score
timeFrame: 4 weeks post operative
measure: KOOS-12 Knee Survey
timeFrame: 6 weeks post operative
measure: The Veterans Rand 12-Item Health Survey
timeFrame: 6 weeks post operative
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Jason M Jennings, MD DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hannon CP, Calkins TE, Li J, Culvern C, Darrith B, Nam D, Gerlinger TL, Buvanendran A, Della Valle CJ. The James A. Rand Young Investigator's Award: Large Opioid Prescriptions Are Unnecessary After Total Joint Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2019 Jul;34(7S):S4-S10. doi: 10.1016/j.arth.2019.01.065. Epub 2019 Feb 4.
citation: Jennings JM, Williams MA, Levy DL, Johnson RM, Eschen CL, Dennis DA. Has Self-reported Marijuana Use Changed in Patients Undergoing Total Joint Arthroplasty After the Legalization of Marijuana? Clin Orthop Relat Res. 2019 Jan;477(1):95-100. doi: 10.1097/CORR.0000000000000339.
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citation: Khelemsky Y, Goldberg AT, Hurd YL, Winkel G, Ninh A, Qian L, Oprescu A, Ciccone J, Katz DJ. Perioperative Patient Beliefs Regarding Potential Effectiveness of Marijuana (Cannabinoids) for Treatment of Pain: A Prospective Population Survey. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):652-659. doi: 10.1097/AAP.0000000000000654.
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citation: Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17.
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