Dronabinol After Arthroscopic Surgery

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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: Drug: Dronabinol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dronabinol; Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery	Drug: Dronabinol; 5mg 2x daily for 7 days; Other Names: Marinol
Placebo Comparator: Placebo; Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery	Drug: Placebo; 1 caplet 2x daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Count of number of hydrocodone/acetaminophen tablet consumed	up to 7 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog Scale (VAS)	Scored from 0 (no pain) to 10 (worst possible pain)	up to 7 days post-surgery
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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Vehniah K Tjong, MD, Northwestern Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Knee Arthroscopy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Osteoarthritis; Osteoarthritis, Knee; Knee Injuries; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: STU00213383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes