Dronabinol After Arthroscopic Surgery

Study Overview
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Brief Summary
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The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.

Official Title
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Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial

Conditions
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Knee Osteoarthritis, Knee Injuries, Meniscus Tear, Synovitis of Knee, Knee Ligament Injury, Chondral Injury of Left Knee, Chondral Injury of Right Knee, Loose Body Knee

Intervention / Treatment
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* Drug: Dronabinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Patient who will undergo arthroscopic surgery of the knee including, but not limited to, Meniscectomy Synovectomy Chondroplasty Loose body removal Exclusion Criteria: Patients under age 18 years Patients who cannot provide consent Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period Patients with an allergy to any of the study drugs Patient who are lactose-intolerant Revision surgery Open surgery Comorbidities preventing surgery Patients with a history of mania, depression, or schizophrenia Patients taking any of the following drugs or supplements Anticholinergic agents Benzodiazepines Central nervous system depressants Droperidol Hydroxyzine Levomepromazine or methotrimeprazine Monoamine oxidase inhibitors Ritonavir Selective serotonin reuptake inhibitors Sympathomimetics St. John's Wort Current diagnosed alcohol or drug abuse Patients who cannot or will not abide by the medication restrictions listed below Medication restrictions Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dronabinol<br>Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery | Drug: Dronabinol<br>* 5mg 2x daily for 7 days<br>* Other names: Marinol;|
| Placebo Comparator: Placebo<br>Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery | Drug: Placebo<br>* 1 caplet 2x daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Count of number of hydrocodone/acetaminophen tablet consumed | up to 7 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analog Scale (VAS) | Scored from 0 (no pain) to 10 (worst possible pain) | up to 7 days post-surgery | 
| Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome). | up to 21 days post-surgery | 
| PROMIS Bank v2.0 - Pain Behavior | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome). | up to 21 days post-surgery | 
| PROMIS Bank v2.0 - Physical Function | PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning. | up to 21 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroscopy