Dronabinol After Arthroscopic Surgery

Northwestern University

Status and phase: Enrolling; Phase 3

Conditions: Knee Injuries; Chondral Injury of Right Knee; Meniscus Tear; Knee Ligament Injury; Chondral Injury of Left Knee; Loose Body Knee; Synovitis of Knee; Knee Osteoarthritis

Treatments: Drug: Dronabinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05335252

STU00213383

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 2 patient groups, including a placebo group

Dronabinol

Experimental group

Description:

Patients will received dronabinol (5mg) twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Treatment:

Drug: Dronabinol

Placebo

Placebo Comparator group

Description:

Patients will received placebo twice a day for 7 days in addition to standard pain medication protocol after arthroscopic knee surgery

Treatment:

Drug: Placebo