Dronabinol After Arthroscopic Surgery

February 29, 2024 updated by: Vehniah Tjong, Northwestern University

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vehniah K Tjong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: up to 7 days post-surgery
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)
Time Frame: up to 7 days post-surgery
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
Time Frame: 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).
up to 21 days post-surgery
PROMIS Bank v2.0 - Pain Behavior
Time Frame: 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).
up to 21 days post-surgery
PROMIS Bank v2.0 - Physical Function
Time Frame: 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.
up to 21 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

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 (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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