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

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

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Dronabinol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dronabinol<br>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. | Drug: Dronabinol<br>* 2.5mg 2 times a day for 30 days after total knee replacement<br>* Other names: Marinol;|
| Placebo Comparator: placebo<br>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. | Other: Placebo<br>* 2 times a day for 30 days after total knee replacement<br>* Other names: Lactose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Equivalence | Morphine Equivalence of pain medication used after a total knee replacement | 30 day's post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea | Patients post operative nausea will be collected as none/mild/moderate/severe | 30 day's post operative | 
| Defense and Veterans Pain Scale | Patients will keep a pain log after their joint replacement on a scale of 0 - 10 | 30 day's post operative | 
| The Pittsburgh Sleep Quality Index | To monitor sleeping habits | 4 weeks and 6 weeks post operative | 
| Knee Society Score | Patient reported outcome | 4 weeks post operative | 
| KOOS-12 Knee Survey | Patient reported outcome | 6 weeks post operative | 
| The Veterans Rand 12-Item Health Survey | Patient reported outcome | 6 weeks post operative |