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Dronabinol After Arthroscopic Surgery

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05335252
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
13.1
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Actual Study Start Date :
Jun 28, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption [up to 7 days post-surgery]

      Count of number of hydrocodone/acetaminophen tablet consumed

    Secondary Outcome Measures

    1. Pain Visual Analog Scale (VAS) [up to 7 days post-surgery]

      Scored from 0 (no pain) to 10 (worst possible pain)

    2. 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).

    3. 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).

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vehniah Tjong, Assistant Professor, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05335252
    Other Study ID Numbers:
    • STU00213383
    First Posted:
    Apr 19, 2022
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jul 1, 2022
    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
    Keywords provided by Vehniah Tjong, Assistant Professor, Northwestern University
    Knee Arthroscopy
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Synovitis
    Wounds and Injuries
    Knee Injuries
    Dronabinol

    Study Results

    No Results Posted as of Jul 5, 2022