Phase 4 N=114 Randomized Triple-blind Treatment

Dronabinol in Total Knee Arthroplasty (TKA)

Total Knee Arthroplasty · Opioid Use

Bottom Line

View on ClinicalTrials.gov: NCT04734080 ↗

Enrolled (actual)

114

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Cumulative Opioid Consumption 24-48 Hours Post-operatively — 8; 15 morphine milligram equivalents — p=0.27

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dronabinol 5mg Cap (Drug); Placebo oral tablet (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Opioid Consumption 24-48 Hours Post-operatively	8; 15	0.27
SECONDARY Time to Reach Discharge From Physical Therapy	19.4; 20.6	0.43
SECONDARY Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)	3.63; 4.04; 5.68; 6.40; 4.46; 4.97	0.443
SECONDARY Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)	2.13; 1.75; 1.39; 1.54; 2.21; 2.18	0.503
SECONDARY Pain With Physical Therapy	3.09; 3.54; 5.04; 5.30	0.378
SECONDARY Length of Hospital Stay (Hours)	26.1; 25.2	0.636
SECONDARY the Number of Desaturation Events	1; 2.5	0.346
SECONDARY PainOUT Scale Questions	3.92; 4.64; 6.08; 5.95; 4.92; 5.32	0.208
SECONDARY PainOut Count Questions	44; 50; 50; 48; 48; 47	—
SECONDARY DN4 Score	0.43; 0.32; 0.72; 0.56; 1.39; 0.65	0.441
SECONDARY Opioid-Related Symptom Distress (ORSDS) Scale	0; 0; 0; 0	0.30
SECONDARY Non-opioid Analgesic Consumption	42; 42; 51; 51; 46; 44	—
SECONDARY Sleep Disturbance: Total Sleep Time	570; 596	0.632
SECONDARY Sleep Disturbance: Wake After Sleep Onset	75; 64	0.632
SECONDARY Sleep Disturbance: Sleep Efficiency	88.2; 89	0.632
SECONDARY Sleep Disturbance: Number of Awakenings	23; 20	0.632
SECONDARY Cognitive Assessment	0; 0; 1; 0; 2; 2	—
SECONDARY Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1	15; 15	0.80
SECONDARY Opioid Consumption at Postoperative Day 90	0; 2	—

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

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
Sleep Apnea

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04734080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.