Dronabinol in Total Knee Arthroplasty (TKA)

NCT ID: NCT04734080

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-04-01

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:

1. Does perioperative dronabinol use (starting in the immediate preoperative period (enrollment before 1 PM), with BID dosing concluding the evening of POD2) affect postoperative opioid consumption 24-48 hours following total knee arthroplasty?

2. Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation?

3. Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control?

4. Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients?

5. Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use?

Participants will:

• 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 affect postoperative opioid consumption 24-48 hours following their total knee arthroplasty surgery.

Detailed Description

The objective of this study is to examine the possible therapeutic advantages of administering perioperative dronabinol to individuals who are undergoing unilateral total knee arthroplasty (TKA). With the utilization of contemporary regional anesthetic procedures and peripheral nerve blocks, pain management is typically effective in the immediate aftermath of total knee arthroplasty (TKA) within the first day after surgery. Rebound pain is shown to occur on the second day following postoperative discharge (POD2), once the analgesic blocks administered during the procedure have ceased to be effective. Previous studies have suggested that dronabinol, a synthetic form of THC, may have potential analgesic properties. Our goal is to find out if giving dronabinol before surgery could lower the number of opioids that people need on postoperative day 2 (POD2) in people who are having total knee arthroplasty (TKA). This research could provide valuable insights into alternative pain management strategies for TKA patients, potentially minimizing opioid-related side effects and improving overall patient outcomes.

Conditions

Total Knee Arthroplasty; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dronabinol

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.

Group Type: EXPERIMENTAL

Dronabinol 5mg Cap

Intervention Type: DRUG

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: OTHER

Non-active placebo

Interventions

Dronabinol 5mg Cap

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

Intervention Type: DRUG

Placebo oral tablet

Non-active placebo

Intervention Type: OTHER

Other Intervention Names

marinol; placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• BMI ≥40

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kethy Jules-Elysee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2019-1416

Identifier Type: -

Identifier Source: org_study_id