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Active, Not Recruiting

NCT Number: NCT05335252

Dronabinol After Arthroscopic Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Chondral Injury of Left Knee Chondral Injury of Right Knee Joint Diseases Knee Injuries Knee Ligament Injury Leg Injuries Loose Body Knee Meniscus Tear Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Synovitis of Knee Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dronabinol

Drug

5mg 2x daily for 7 days

Other names: Marinol

Placebo

Drug

1 caplet 2x daily for 7 days

Primary outcomes

  1. Opioid consumption

    Time frame: up to 7 days post-surgery

    Count of number of hydrocodone/acetaminophen tablet consumed

Secondary outcomes

  1. Pain Visual Analog Scale (VAS)

    Time frame: 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

    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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 19, 2022
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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