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Clinical Trials/NCT04298528
NCT04298528RecruitingPhase 3

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

Colorado Joint Replacement1 site in 1 country460 target enrollmentStarted: February 5, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
460
Locations
1
Primary Endpoint
Morphine Equivalence
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
21 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

dronabinol

Experimental

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.

Intervention: Dronabinol (Drug)

placebo

Placebo Comparator

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.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Morphine Equivalence

Time Frame: 30 day's post operative

Morphine Equivalence of pain medication used after a total knee replacement

Secondary Outcomes

  • Defense and Veterans Pain Scale(30 day's post operative)
  • The Pittsburgh Sleep Quality Index(4 weeks and 6 weeks post operative)
  • The Veterans Rand 12-Item Health Survey(6 weeks post operative)
  • Nausea(30 day's post operative)
  • KOOS-12 Knee Survey(6 weeks post operative)
  • Knee Society Score(4 weeks post operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jason Jennings

Orthopedic Surgeon

Colorado Joint Replacement

Study Sites (1)

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