Dronabinol in Total Knee Arthroplasty (TKA)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    110
  • sponsor
    Hospital for Special Surgery, New York
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Updated on 4 October 2022
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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

Details
Condition Total Knee Arthroplasty, Opioid Use
Treatment Placebo Oral Tablet, Dronabinol 5mg Cap
Clinical Study IdentifierNCT04734080
SponsorHospital for Special Surgery, New York
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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
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