Prospective Blinded Randomized Controlled Trial Evaluating the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Mineral Oil
- Conditions
- Pain, Joint
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Postoperative change in pain and change the need for opiates after total knee arthroplasty.
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •patients \<18 and \>80
- •any patient who does not meet the inclusion criteria listed for this study
Arms & Interventions
Group 2: (MO cohort)
Roll on stick containing mineral oils only (MO cohort)
Intervention: Mineral Oil
Group 1: (CBD + MO cohort)
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
Intervention: CBD
Group 1: (CBD + MO cohort)
Roll on stick containing CBD and mineral oils (CBD + MO cohort)
Intervention: Mineral Oil
Group 3: (CBD Cohort)
Roll on stick containing CBD only (CBD cohort)
Intervention: CBD
Group 4: (Roll-on stick only with NO CBD or MO-placebo cohort)
Roll on stick with neither CBD nor essential oils (Roll-on stick only with NO CBD or MO-placebo cohort)
Intervention: Placebo
Outcomes
Primary Outcomes
Postoperative change in pain and change the need for opiates after total knee arthroplasty.
Time Frame: 14 days
opioid consumption after surgery will be calculated in morphine equivalents