Clinical trial NCT05335252: Dronabinol After Arthroscopic Surgery
Official title: Dronabinol for the Treatment of Postoperative Pain After Arthroscopic Surgery: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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
Keywords: Knee Arthroscopy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: up to 7 days post-surgery
Secondary outcomes:
measure: Pain Visual Analog Scale (VAS)
timeFrame: up to 7 days post-surgery
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Bank v1.1 - Pain Interference
timeFrame: up to 21 days post-surgery
measure: PROMIS Bank v2.0 - Pain Behavior
timeFrame: up to 21 days post-surgery
measure: PROMIS Bank v2.0 - Physical Function
timeFrame: up to 21 days post-surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern Feinberg School of Medicine
name: Vehniah K Tjong, MD
role: PRINCIPAL_INVESTIGATOR
References: