Total Knee ArthroplastyPhase 4NCT04734080
Dronabinol in Total Knee Arthroplasty (TKA)
A Phase 4 study testing Dronabinol 5mg Cap in people with Total Knee Arthroplasty and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Arthroplasty, Opioid Use
- What is being tested?
- Dronabinol 5mg Cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty
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:
- 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?
- Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation?
- Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control?
- Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients?
- Is there a change in number of postoperative oxygen desaturation events in patients following total knee arthroplasty based on perioperative dronabinol use?
Read more
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.
Read the 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
- Being tested
- Dronabinol 5mg Cap, Placebo oral tablet
- Keywords
- Knee Arthroplasty, Dronabinol, Opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dronabinol 5mg CapDrug
Also called marinol
Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
Placebo oral tabletOther
Also called placebo
Non-active placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-48 hours post-operatively
Secondary outcomes (18)
Time to Reach Discharge From Physical Therapy
Time to reach discharge physical therapy goals, as defined by the number of hours required to meet the following criteria: stable vital signs during Physical therapy (PT), safe independent transfer from bed to standing as well as transfer in and out of seated position, ability to walk 40 feet only with aid of crutch or walker. This outcome will be measured prior to patient discharge.
Measured: Post operative day 0 (beginning in the PACU)-Discharge
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
Patient pain with ambulation on postoperative day (POD) 1, 2, 7, 90 and 180, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Measured: Post operative day 1, 2, 7, 90 and 180
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
Patient pain at rest upon PACU entry and in the morning of postoperative day (POD)1, POD2, POD7, POD90 and POD180 defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Measured: Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180
Pain With Physical Therapy
Patient pain during morning physical therapy on postoperative day (POD)1 and 2, defined by patient reported Numeric Rating Scale (NRS) pain score, (from 0-no pain to 10-worst pain imaginable).
Measured: Postoperative Day 1 and Postoperative Day 2
Length of Hospital Stay (Hours)
Hospital length of stay from procedure start time to time of discharge
Measured: Post operative day 0 (beginning in the PACU)-Discharge
the Number of Desaturation Events
Postoperative desaturation events are defined as the number of times oxygen saturation dropped below 88% for at least 20 seconds or more. The number of such events will be counted per subject during the monitoring period, beginning in the immediate postoperative period on postoperative day (POD)0 (in the PACU) and will continue until the end post operative day 2/patient discharge, whichever occurs first. Oxygen desaturation is defined when measured SpO2 is less than 88%. Measurements will only be recorded if the desaturation event happens for 20 seconds or longer.
Measured: Post operative day 0 (beginning in the PACU)-48 hours post operative discharge
PainOUT Scale Questions
PainOut assesses post-surgical pain by collecting data on pain intensity, interference with daily activities, and other related factors. Questionnaire uses multiple scales from 0 (none/not at all/did not interfere/extremely dissatisfied) to 10 (extreme/severe/worst pain imaginable/completely interfered/extremely satisfied). Pain severity/Interference/Symptom questions are scored from 0-10, with higher scores indicating worse outcomes. With a scale of 0-10, higher scores indicate better outcomes for the following questions: decision participation question and satisfaction question.
The following questions used a scale of 1-11, where 1=0% and 11=100%:
Pain relief (a higher percentage indicates better outcome) Time with severe pain (a higher percentage indicates worse outcome)
Measured: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge
PainOut Count Questions
The following questions used a scale of Yes/No, reporting number of patients with Yes
- Been out of bed since surgery
- Would have liked more pain treatment
- Received information about pain treatment
- Used non-medicine methods to relieve pain
- Persistent painful condition for 3 months or more
Measured: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge
DN4 Score
DN4 questionnaire to assess neuropathic pain on postoperative day (POD)1, 2, 7, 90 and 180. The DN4 questionnaire is a series of Yes or No questions that revolves around the characteristics that may suggest the presence or development of neuropathic conditions/pain (burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching, hypoesthesia to touch, hypoesthesia to pinprick, pain increased by brushing). Total score is calculated by summing the total of the individual question scores, for a total score range of 0-10, with a score of greater than or equal to 4 indicating the patient may be suffering from neuropathic pain.
Measured: 24 hours post operative discharge, 48 hours post operative discharge, 7days post operative discharge, 3 months post operative discharge, 6 months post operative discharge
Opioid-Related Symptom Distress (ORSDS) Scale
The Opioid-Related Symptom Distress Scale (ORSDS) is a scale that assesses three dimensions of symptom distress (frequency, severity, and bothersomeness) for 12 symptoms. The symptom-specific ORSDS is calculated by taking the average of the three symptom distress dimensions. The composite score will be reported for postoperative day (POD)1 and POD2. If a patient denies experiencing a particular symptom, their response will be coded as 0.
If they do:
Frequency will be assessed using a 4 point scale:
- rarely
- occasionally
- frequently
- almost constantly with 1 being the lowest and 4 being the highest.
Severity is assessed using a 4 point scale:
- slight
- moderate
- severe
- very severe with 1 being the lowest and 4 being the highest.
Bothersomeness is assessed using a 5 point scale:
- not at all
- a little bit
- somewhat
- quite a bit
- very much with 1 being the lowest and 5 being the highest.
Measured: 24 hours post operative discharge, 48 hours post operative discharge
Non-opioid Analgesic Consumption
Patient consumption of non-opioid analgesics in the post-anesthesia care unit (PACU) and on postoperative day (POD)1, POD2, POD7. This was measured for acetaminophen, ibuprofen, ketorolac, meloxicam, naproxen, and gabapentin as yes/no. Number of participants who report "yes" for each non-opioid analgesic is reported.
Measured: PACU, POD1, POD2, POD7
Sleep Disturbance: Total Sleep Time
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured during the first 24 hours postoperatively.
Measured: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Wake After Sleep Onset
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Wake After Sleep Onset is the duration of time a patient was awake after falling asleep and before getting out of bed. Measured during the first 24 hours postoperatively.
Measured: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Sleep Efficiency
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Sleep Efficiency is the ratio between total sleep time and the total time in bed. Measured during the first 24 hours postoperatively. Sleep Efficiency ratio is expressed as a percentage, where higher values represent better outcomes.
Measured: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Number of Awakenings
Sleep disturbance via actigraphy measurement using the ActiGraph wGT3X-BT activity monitor. Measured as number of awakenings during the first 24 hours postoperatively.
Measured: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Cognitive Assessment
Measured as yes/no for a series of 13 questions asking patients if they have experienced any: change of mood, difficulty with memory, slurring of speech, blurred vision, hallucinations, increased awareness of surroundings, palpitations, headache, dizziness, drowsiness, dry mouth, involuntary muscle twitching, or tremors. Number of participants who report "yes" for each symptom is reported.
Measured in the post-anesthesia care unit (PACU), between PACU exist and midnight (Post-op), postoperative day (POD)1, POD2
Measured: PACU, Post-Op, POD1, POD2
Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1
Opioid consumption measured in morphine milligram equivalents in the post-anesthesia care unit and postoperative day 1 (analyzed as 0-24 hours after surgery)
Measured: post-anesthesia care unit and postoperative day 1
Opioid Consumption at Postoperative Day 90
Number of participants reporting opioid use at postoperative day 90.
Measured: Postoperative Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start9 Mar 2021
- Primary completion6 Oct 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kethy Jules-Elysee, M.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734080
- Sponsor's protocol ID
- 2019-1416
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2021
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
Publications
Thor P, Perlstein M, Illescas A, Lauzadis J, Sheetz M, Tailor M, Puglisi A, Popovic M, Oxendine JA, Lin Y, Kirksey MA, YaDeau JT, Kumar K, Baaklini LR, Liu J, Cheng S, Mayman DJ, Jerabek SA, Westrich GH, Cushner FD, Sculco PK, Sculco TP, Ast MP, Gonzalez Della Valle A, Sideris A, Jules-Elysee KM. Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty: A Double-blinded Randomized Controlled Trial. Anesthesiology. 2026 May 1;144(5):1239-1242. doi: 10.1097/ALN.0000000000005945. Epub 2026 Mar 16. No abstract available.
PubMed 41838938
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04734080
- Acronym / sponsor ID
- 2019-1416
- Conditions
- Total Knee Arthroplasty, Opioid Use
- Keywords
- Knee Arthroplasty, Dronabinol, Opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Is there an effect of perioperative dronabinol use in the total knee arthroplasty patient on POD2 pain scores with ambulation?
- Will hospital length of stay following total knee arthroplasty be affected in patients who use perioperative dronabinol as compared to control?
- Does the use of perioperative dronabinol affect time to reach physical therapy discharge goals in postoperative total knee arthroplasty patients?
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: Dronabinol 5mg Cap57 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. |
| Placebo | Placebo comparator | Other: Placebo oral tablet57 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol 5mg CapAlso: marinolDronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients. | Drug | Dronabinol |
| Placebo oral tabletAlso: placeboNon-active placebo | Other | Placebo |
Primary outcome
Cumulative Opioid Consumption 24-48 Hours Post-operatively
Time frame: 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.
18 secondary outcomes
Time to Reach Discharge From Physical Therapy
Time frame: Post operative day 0 (beginning in the PACU)-Discharge
Average Pain Score With Ambulation Reported on a Numeric Rating Scale (NRS)
Time frame: Post operative day 1, 2, 7, 90 and 180
Average Pain Score at Rest Reported on a Numeric Rating Scale (NRS)
Time frame: Post operative day 0 (beginning in the PACU), POD 1, 2, 7, 90 and 180
Pain With Physical Therapy
Time frame: Postoperative Day 1 and Postoperative Day 2
Length of Hospital Stay (Hours)
Time frame: Post operative day 0 (beginning in the PACU)-Discharge
the Number of Desaturation Events
Time frame: Post operative day 0 (beginning in the PACU)-48 hours post operative discharge
PainOUT Scale Questions
Time frame: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge
PainOut Count Questions
Time frame: 24 hours post operative discharge, 48 hours post operative discharge, 7 days post operative discharge, 90 days post operative discharge, 180 days post operative discharge
DN4 Score
Time frame: 24 hours post operative discharge, 48 hours post operative discharge, 7days post operative discharge, 3 months post operative discharge, 6 months post operative discharge
Opioid-Related Symptom Distress (ORSDS) Scale
Time frame: 24 hours post operative discharge, 48 hours post operative discharge
Non-opioid Analgesic Consumption
Time frame: PACU, POD1, POD2, POD7
Sleep Disturbance: Total Sleep Time
Time frame: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Wake After Sleep Onset
Time frame: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Sleep Efficiency
Time frame: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Sleep Disturbance: Number of Awakenings
Time frame: Post operative day 0 (beginning in the PACU)- 24 hours post operative
Cognitive Assessment
Time frame: PACU, Post-Op, POD1, POD2
Opioid Consumption in the Post-anesthesia Care Unit and Postoperative Day 1
Time frame: post-anesthesia care unit and postoperative day 1
Opioid Consumption at Postoperative Day 90
Time frame: Postoperative Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41838938Thor P, Perlstein M, Illescas A, Lauzadis J, Sheetz M, Tailor M, Puglisi A, Popovic M, Oxendine JA, Lin Y, Kirksey MA, YaDeau JT, Kumar K, Baaklini LR, Liu J, Cheng S, Mayman DJ, Jerabek SA, Westrich GH, Cushner FD, Sculco PK, Sculco TP, Ast MP, Gonzalez Della Valle A, Sideris A, Jules-Elysee KM. Effects of Perioperative Dronabinol Use in Total Knee Arthroplasty: A Double-blinded Randomized Controlled Trial. Anesthesiology. 2026 May 1;144(5):1239-1242. doi: 10.1097/ALN.0000000000005945. Epub 2026 Mar 16. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kethy Jules-Elysee, M.D. principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dronabinol 5mg Cap in people with Total Knee Arthroplasty and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Opioid Consumption 24-48 Hours Post-operatively (time frame: 24-48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.