THAPhase 4NCT06807866
Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
A Phase 4 study testing Duloxetine in people with THA, run by University of Miami at 1 site in United States.
Trial summary
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- THA
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Patients undergoing primary total hip arthroplasty
- Ambulatory patient prior to fracture
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Who cannot join
- Previous hemiarthroplasty or THA on ipsilateral hip
- History of Complex Regional Pain Syndrome in ipsilateral extremity
- History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
- Acute or chronic hip infection in ipsilateral extremity
- Pregnant or breastfeeding
- Open fracture
Show all 14Show fewer
- Polytrauma
- Intravenous or drug users within 6 months of surgery
- Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
- Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
- Severe renal dysfunctions, such as glomerular filtration rate less than 30
- Moderate to severe depression as diagnosed by a clinician
- Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
- History of uncontrolled narrow angle glaucoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Natalia Cruz, MD, 3056895195, nxc971@miami.edu
Ryan Hellinger, BA, 3056895195, rlh147@miami.edu
About this study
Official title: Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
- Conditions
- THA
- Being tested
- Duloxetine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Participants will come in person and receive a one time 60 mg dose by mouth.
PlaceboOther
Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine group | Experimental | Participants will be in this group for up to 2 hours. Receives: Drug: Duloxetine |
| Placebo group | Placebo comparator | Participants will be in this group for up to 2 hours. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Milligram Morphine Equivalent (MME)
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief
Measured: Up to 24 hours
Secondary outcomes (4)
Change in Pain as measured by Visual Analog Scale (VAS)
The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.
Measured: Baseline, up to 24 hours, 3 months
Musculoskeletal function as measured by SMFA questionnaire
The Short Musculoskeletal Function Assessment Questionnaire (SMFA) consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function
Measured: Up to 3 months
Hospital Length of stay measured in hours
Hospital Length of stay measured in hours
Measured: Up to 96 hours
Ambulation distance measured by meters
Ambulation distance measured by meters
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THAStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor Hernandez, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807866
- Sponsor's protocol ID
- 20240579
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
- ClinicalTrials.gov ID
- NCT06807866
- Acronym / sponsor ID
- 20240579
- Conditions
- THA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine group | Experimental | Drug: DuloxetineParticipants will be in this group for up to 2 hours. |
| Placebo group | Placebo comparator | Other: PlaceboParticipants will be in this group for up to 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 18 years of age
- Patients undergoing primary total hip arthroplasty
- Ambulatory patient prior to fracture
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Key exclusion criteria (14 listed)
- Previous hemiarthroplasty or THA on ipsilateral hip
- History of Complex Regional Pain Syndrome in ipsilateral extremity
- History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
- Acute or chronic hip infection in ipsilateral extremity
- Pregnant or breastfeeding
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 |
|---|---|---|
| DuloxetineParticipants will come in person and receive a one time 60 mg dose by mouth. | Drug | Duloxetine group |
| PlaceboParticipants will come in person and receive a one time 60 mg placebo pill dose by mouth. | Other | Placebo group |
Primary outcome
Total Milligram Morphine Equivalent (MME)
Time frame: Up to 24 hours
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief
4 secondary outcomes
Change in Pain as measured by Visual Analog Scale (VAS)
Time frame: Baseline, up to 24 hours, 3 months
Musculoskeletal function as measured by SMFA questionnaire
Time frame: Up to 3 months
Hospital Length of stay measured in hours
Time frame: Up to 96 hours
Ambulation distance measured by meters
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Victor Hernandez, MD principal investigator
University of Miami
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 Duloxetine in people with THA, run by University of Miami 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor Hernandez, MD (3056895195, vhh1@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Milligram Morphine Equivalent (MME) (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.