A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects. In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.

Official Title
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Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

Conditions
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Pain, Joint, Pain, Postoperative, Total Knee Arthroplasty

Intervention / Treatment
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* Drug: CBD
* Drug: Mineral Oil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have general anesthesia Patients who have documented allergic reactions to ropivacaine in the local infiltration agents Patients who have a contra-indication to the use of non-steroidal anti-inflammatory medications or are using therapeutic anticoagulation precluding them from using non-steroidal anti-inflammatory medications Patients unable to complete a 100-ft walk baseline Patients undergoing total knee arthroplasty as a conversion procedure following previous surgery Patients undergoing TKA for posttraumatic arthritis Patients undergoing TKA for steroid-induced or spontaneous avascular necrosis Workers compensation patients Patients refusing or not candidates for peripheral nerve blocks Patients undergoing unicompartmental knee arthroplasty Patients undergoing patellofemoral arthroplasty Patients undergoing bilateral simultaneous or sequential primary total knee arthroplasty within the same hospital stay Patients who have previously reported allergy to tetrahydrocannabinol or other cannabinoid compounds or develop allergic reactions to the formulation following use Patients who are pregnant or choosing to be pregnant during the 6-week study period or are breast feeding during the study period Patients who are on chronic narcotics pre-operatively Patients who have end-stage cirrhosis, end-stage renal failures, or psychiatric conditions preventing adequate assessment of study outcome metrics Patients with adequate cognitive function to participate and complete questionnaires for the study. Patients unable or unwilling to follow-up and complete questionnaires for the study Patients with active cancer and undergoing treatment precluding the assessment of outcome metrics Patients with a history or diagnosis of chronic pain syndrome or Complex regional pain syndrome (CRPS) Patients who are determined to be in severe pain from other concomitant conditions Exclusion Criteria: patients <18 and >80 any patient who does not meet the inclusion criteria listed for this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Group 1: (CBD + MO cohort)<br>Roll on stick containing CBD and mineral oils (CBD + MO cohort) | Drug: CBD<br>* CBD oil Roll-On Stick<br>Drug: Mineral Oil<br>* Mineral Oil- Roll on Stick<br>|
| Active Comparator: Group 2: (MO cohort)<br>Roll on stick containing mineral oils only (MO cohort) | Drug: Mineral Oil<br>* Mineral Oil- Roll on Stick<br>|
| Active Comparator: Group 3: (CBD Cohort)<br>Roll on stick containing CBD only (CBD cohort) | Drug: CBD<br>* CBD oil Roll-On Stick<br>|
| Placebo Comparator: Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)<br>Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort) | Drug: Placebo<br>* Roll- On stick with no CBD and no Mineral Oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative change in pain and change the need for opiates after total knee arthroplasty. | opioid consumption after surgery will be calculated in morphine equivalents | 14 days |