INTERVENTIONALUNKNOWNNCT04298528

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

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-01-10

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 460 (ESTIMATED)
Start date: 2020-02-05
Sponsor: Colorado Joint Replacement
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL

Interventions

What was registered

DRUG

Dronabinol

2.5mg 2 times a day for 30 days after total knee replacement

Marinol

OTHER

Placebo

2 times a day for 30 days after total knee replacement

Lactose

Eligibility

Population and criteria

Sex: ALL
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Not accepted

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

primary measures

Morphine Equivalence

Time frame: 30 day's post operative

Morphine Equivalence of pain medication used after a total knee replacement

secondary outcomes

secondary measures

Nausea

Time frame: 30 day's post operative

Patients post operative nausea will be collected as none/mild/moderate/severe

Defense and Veterans Pain Scale

Time frame: 30 day's post operative

Patients will keep a pain log after their joint replacement on a scale of 0 - 10

The Pittsburgh Sleep Quality Index

Time frame: 4 weeks and 6 weeks post operative

To monitor sleeping habits

Knee Society Score

Time frame: 4 weeks post operative

Patient reported outcome

KOOS-12 Knee Survey

Time frame: 6 weeks post operative

Patient reported outcome

The Veterans Rand 12-Item Health Survey

Time frame: 6 weeks post operative

Patient reported outcome

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 0c9e8ca7-3f2e-48ce-a759-7b4dacbb470f
Retrieved: 11/09/2026, 14:54:28
SHA-256: 92ebb140f7ae35d1e304eea53bf1b91c3d5621eb4e27c166e5e3bec73ad1b684