Dronabinol in Total Knee Arthroplasty (TKA)

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the potential therapeutic benefit of perioperative dronabinol use in patients undergoing unilateral total knee arthroplasty (TKA). With current advanced regional anesthetic techniques and peripheral nerve blocks, pain is generally well controlled following TKA on post operative day (POD) 1. There is a rebound pain that exists, however, on post operative discharge day 2 (POD2) when these blocks are no longer effective. We aim to study a potential reduction in opioid consumption on POD2 with perioperative dronabinol use in TKA patients

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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