Dronabinol in Total Knee Arthroplasty (TKA)

NCT04734080 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-1416
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this double-blinded randomized controlled trial is to compare whether the addition of Dronabinol compared to a placebo will affect opioid intake in patients undergoing a total knee arthroplasty. The main question it aims to answer are:

• Be randomized to take the dronabinol or placebo medication in 5 dosage
• Answer survey questions in regard to pain, postop nausea/vomiting, cognitive/adverse event, and outcome quality and support of decision making.
• Be connected to a Masimo to record oxygen saturation and an Actigraph to record sleep quality. Researchers will compare two groups: 1) intervention group and 2) control group to see if dronabinol affects postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.

Conditions

Total Knee Arthroplasty; Opioid Use

Keywords

Knee Arthroplasty; Dronabinol; Opioid

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption 24-48 Hours Post-operatively

  The primary outcome of the study will be cumulative patient opioid consumption 24-48 hours post operatively, defined by total morphine equivalents (MEs). This outcome will be measured starting at recovery room entry and conclude at 48 hours after anesthesia stop time.

  24-48 hours post-operatively

Secondary Outcomes (18)

• Time to Reach Discharge From Physical Therapy

  Post operative day 0 (beginning in the PACU)-Discharge

• Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)

  Post operative day 1, 2, 7, 90 and 180

• Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)

  Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180

• Pain With Physical Therapy

  Postoperative Day 1 and Postoperative Day 2

• Length of Hospital Stay (Hours)

  Post operative day 0 (beginning in the PACU)-Discharge

Study Arms (2)

Dronabinol

EXPERIMENTAL

57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of 5 mg of Dronabinol beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.

Drug: Dronabinol 5mg Cap

Placebo

PLACEBO COMPARATOR

57 subjects undergoing primary Total Knee Arthroplasty will be randomized to receive BID (2x/day) dosing of a non-active placebo pill beginning on the day of surgery and with the final dose on the morning of POD (postoperative day) 2.

Other: Placebo oral tablet

Interventions

Dronabinol 5mg Cap DRUG

Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.

Also known as: marinol

Dronabinol

Placebo oral tablet OTHER

Non-active placebo

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18-70 years old with osteoarthrosis scheduled for primary unilateral knee arthroplasty with a participating surgeon
• Planned use of regional anesthetic technique during surgery involving infiltration between the popliteal artery and the capsule of the posterior knee (IPACK), adductor canal block (ACB) and periarticular injection (PAI)
• Ability to follow study protocol

You may not qualify if:

• Patients less than 18 years of age or older than 70 years of age
• Contraindication to regional or neuraxial anesthetic
• Intended use of general anesthesia
• Revision surgery
• Chronic opioid use (for \>3 months prior to surgery)
• Cannabis/cannabinoid use within the last 3 months
• ASA class of IV or greater
• Active or history of major mental history (as defined by the Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\]; i.e. major depressive disorder, anxiety, bipolar disorder, schizophrenia)
• History of seizures
• Use of antidepressants
• Use of anticonvulsants
• Use of Coumadin
• Use of Disulfuram
• Use of Metronidazole
• Non-English speakers

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Dronabinol; Capsules

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Maya Tailor
• Organization: Hospital for Special Surgery

tailorm@hss.edu

646-714-6828

Study Officials

• Kethy Jules-Elysee, M.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Throughout cannabinoid research, there has been concern about potential unblinding due to the side effect profile of this class of medication. Prior meta-analyses have advocated for the use of active placebo, with concern that unblinding may misrepresent the effects of clinical trials. However, due to evidence of histamine receptor involvement in pain transmission, as well as overlap in antihistamine antiemetic use and common cannabinoid side effect profiles, we have chosen to use non-active placebo. Our hope is to elicit maximum benefit of cannabinoid dosing perioperatively without confounding variables. With use of non-active placebo, we will perform a comprehensive blinding analysis following the study period to ensure adequate blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 2, 2021
• Study Start: March 9, 2021
• Primary Completion: October 6, 2023
• Study Completion: April 1, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.

Locations

US (1)