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NCT05335252 | RECRUITING | Knee Osteoarthritis

Dronabinol After Arthroscopic Surgery
Sponsor:

Northwestern University

Information provided by (Responsible Party):

Vehniah Tjong

Brief Summary:

The purpose of the proposed study is to evaluate the efficacy of dronabinol for postoperative pain after arthroscopic surgery of the knee. The investigators hypothesize that dronabinol will relieve pain, reduce opioid consumption and will result in few negative side effects. If this pilot study shows promising results the investigators will expand the trial to include additional arthroscopic surgeries (hip, shoulder) and other types of orthopaedic surgery.

Condition or disease

Knee Osteoarthritis

Knee Injuries

Meniscus Tear

Synovitis of Knee

Knee Ligament Injury

Chondral Injury of Left Knee

Chondral Injury of Right Knee

Loose Body Knee

Intervention/treatment

Dronabinol

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Actual Study Start Date : 2022-06-28
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Age 18 years or older
  • * Patient who will undergo arthroscopic surgery of the knee including, but not limited to,
  • * Meniscectomy
  • * Synovectomy
  • * Chondroplasty
  • * Loose body removal
Exclusion Criteria
  • * Patients under age 18 years
  • * Patients who cannot provide consent
  • * Patients who are pregnant, breast feeding, or are trying to become pregnant during the study period
  • * Patients with an allergy to any of the study drugs
  • * Patient who are lactose-intolerant
  • * Revision surgery
  • * Open surgery
  • * Comorbidities preventing surgery
  • * Patients with a history of mania, depression, or schizophrenia
  • * Patients taking any of the following drugs or supplements
  • * Anticholinergic agents
  • * Benzodiazepines
  • * Central nervous system depressants
  • * Droperidol
  • * Hydroxyzine
  • * Levomepromazine or methotrimeprazine
  • * Monoamine oxidase inhibitors
  • * Ritonavir
  • * Selective serotonin reuptake inhibitors
  • * Sympathomimetics
  • * St. John's Wort
  • * Current diagnosed alcohol or drug abuse
  • * Patients who cannot or will not abide by the medication restrictions listed below
  • Medication restrictions
  • * Participants must agree to abstain from using recreational or medical marijuana products or cannabidiol (CBD) in any form during the treatment period
  • * Participants should not drink alcohol or take other drugs while taking the study drug or hydrocodone/acetaminophen
Dronabinol After Arthroscopic Surgery

Location Details

NCT05335252

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611