Dronabinol After Arthroscopic Surgery

Knee Osteoarthritis Clinical Trial

Official title:

Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335252
• Other study ID #: STU00213383
• Status: Recruiting
• Phase: Phase 3
• Start date: June 28, 2022
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: Melissa J Shauver, MPH
• Phone: 312-472-6024
• Email: melissa.shauver1[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Knee Ligament Injury
• Knee Osteoarthritis
• Meniscus Tear
• Synovitis
• Synovitis of Knee
• Wounds and Injuries

Intervention

Drug:
• Dronabinol
5mg 2x daily for 7 days
• Placebo
1 caplet 2x daily for 7 days

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Count of number of hydrocodone/acetaminophen tablet consumed	up to 7 days post-surgery
Secondary	Pain Visual Analog Scale (VAS)	Scored from 0 (no pain) to 10 (worst possible pain)	up to 7 days post-surgery
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference	PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population). A low score indicates less pain interference (better outcome) and a high score indicates more pain interference (worse outcome).	up to 21 days post-surgery
Secondary	PROMIS Bank v2.0 - Pain Behavior	PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates less pain (better outcome) and a high score indicates more pain (worse outcome).	up to 21 days post-surgery
Secondary	PROMIS Bank v2.0 - Physical Function	PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50. A low score indicates worse physical functioning and a high score indicates better physical functioning.	up to 21 days post-surgery