Dronabinol After Arthroscopic Surgery

Phase 3

Recruiting

• Conditions: Knee Osteoarthritis; Loose Body Knee; Knee Injuries; Meniscus Tear; Synovitis of Knee; Knee Ligament Injury; Chondral Injury of Left Knee; Chondral Injury of Right Knee
• Interventions: Drug: Placebo; Drug: Dronabinol

• Registration Number: NCT05335252
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-19
• Study Start: 2022-06-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery
Dronabinol	Dronabinol	Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Primary Outcome Measures

Name	Time	Method
Opioid consumption	up to 7 days post-surgery	Count of number of hydrocodone/acetaminophen tablet consumed

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference	up to 21 days post-surgery	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).
Pain Visual Analog Scale (VAS)	up to 7 days post-surgery	Scored from 0 (no pain) to 10 (worst possible pain)
PROMIS Bank v2.0 - Pain Behavior	up to 21 days post-surgery	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).
PROMIS Bank v2.0 - Physical Function	up to 21 days post-surgery	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.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States