Phase 4
Completed N=114
Dronabinol in Total Knee Arthroplasty (TKA)
Source: ClinicalTrials.gov NCT04734080 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Cumulative Opioid Consumption 24-48 Hours Post-operatively — 8; 15 morphine milligram equivalents — p=0.27
◆ Published Evidence
Not yet cited
0citations
Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty: A Double-blinded Randomized Controlled Trial.
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.
Linked Publications
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Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty: A Double-blinded Randomized Controlled Trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT04734080) and the linked publication. 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. Informational only — not medical advice.