Status:
COMPLETED
Dronabinol in Total Knee Arthroplasty (TKA)
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Total Knee Arthroplasty
Opioid Use
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthrop...
Detailed Description
The objective of this study is to examine the possible therapeutic advantages of administering perioperative dronabinol to individuals who are undergoing unilateral total knee arthroplasty (TKA). With...
Eligibility Criteria
Inclusion
- Patients aged between 18-70 years old with osteoarthrosis scheduled for primary unilateral knee arthroplasty with a participating surgeon
- Planned use of regional anesthetic technique during surgery involving infiltration between the popliteal artery and the capsule of the posterior knee (IPACK), adductor canal block (ACB) and periarticular injection (PAI)
- Ability to follow study protocol
Exclusion
- Patients less than 18 years of age or older than 70 years of age
- Contraindication to regional or neuraxial anesthetic
- Intended use of general anesthesia
- Revision surgery
- Chronic opioid use (for \>3 months prior to surgery)
- Cannabis/cannabinoid use within the last 3 months
- ASA class of IV or greater
- Active or history of major mental history (as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\]; i.e. major depressive disorder, anxiety, bipolar disorder, schizophrenia)
- History of seizures
- Use of antidepressants
- Use of anticonvulsants
- Use of Coumadin
- Use of Disulfuram
- Use of Metronidazole
- Non-English speakers
- BMI ≥40
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04734080
Start Date
March 1 2021
End Date
April 1 2024
Last Update
January 24 2025
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021