Total Hip ArthroplastyPhase 2NCT07430228
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
A Phase 2 study testing intravenous administration of oxytocin in people with Total Hip Arthroplasty, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to test whether perioperative intravenous (IV) oxytocin compared to placebo results in faster recovery in disability as measured by daily steps over 56 days after Total Hip Arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- intravenous administration of oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Phase 2
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 and ≤75 years of age
- Scheduled for unilateral, primary total hip arthroplasty surgery
- Generally in good health as determined by the Principal Investigator based on prior medical history, and as assessed to be American Society of Anesthesiologists physical status 1, 2, or 3
- Willing to perform the study procedures
- Able to read and write English and have a stable residence.
Who cannot join
- Hypersensitivity to any ingredient in Pitocin® (marketed preparation of oxytocin for parenteral injection)
- Latex allergy
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the participant at increased risk (e.g., active gynecologic disease in which increased tone would be detrimental such as uterine fibroids with ongoing bleeding)
- Women who are pregnant, are currently nursing or lactating, or have been pregnant within 2 years
- Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
- Past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, Selective Serotonin Reuptake Inhibitors (SSRI's), Monoamine oxidase inhibitors (MAOIs), or the recreational drug ecstasy.
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- Inability to complete questionnaires
- Litigation or workers compensation related to their joint surgery
- Taking > 100 mg morphine equivalents/day
- Suffering from a psychotic disorder or a recent psychiatric hospitalization
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
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Efficacy of Intravenous Oxytocin to Speed Recovery After Total Hip Arthroplasty
The purpose of this study is to test whether perioperative intravenous (IV) oxytocin compared to placebo results in faster recovery in disability as measured by daily steps over 56 days after Total Hip Arthroplasty (THA).
Read the detailed description
This is a single center, NIH funded clinical study at Atrium Health Wake Forest Baptist Medical Center. The investigators will utilize a triple-masked, parallel group, randomized design to compare intravenous (IV) oxytocin to placebo to determine IV oxytocin's actions on speed of recovery from physical disability and postoperative pain after Total Hip Arthroplasty (THA).
- Conditions
- Total Hip Arthroplasty
- Being tested
- intravenous administration of oxytocin, Placebo
- Keywords
- Intravenous (IV) oxytocin, Postoperative pain, Disability
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous administration of oxytocinDrug
Also called Pitocin
Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.
PlaceboDrug
Also called Saline
Saline will be administered intravenously over a period of 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Oxytocin 26 micrograms administered intravenously Receives: Drug: intravenous administration of oxytocin |
| Placebo | Placebo comparator | Placebo administered intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeled daily steps trajectory
Individual trajectories, adjusted for prognostic covariates, of daily steps will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is in units of steps on the first post-discharge day with the lower number of steps indicating more disability and the slope is in units of logarithm of steps per day with the lower number indicating slower recovery from disability - Key models often classify adults into sedentary (<5,000 steps), low active (5,000-7,499), somewhat active (7,500-9,999), or active (≥10,000) trajectories.
Measured: 56 days after surgery
Secondary outcomes (4)
Modeled pain intensity trajectory
Description: Individual trajectories, adjusted for prognostic covariates, of worst daily pain intensity scores (0-10 scale) from daily diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is pain score on the first post-discharge day with the higher score indicating more pain and the slope is in units of logarithm of pain score per day with the lower number indicating slower recovery from pain
Measured: 56 days after surgery
Modeled disability assessments
Individual trajectories, adjusted for prognostic covariates, of World Health Organization Disability Assessment Schedule (WHODAS) 2.0 scores from weekly diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling.
Each item in the WHODAS 2.0 questionnaire is rated on a 5-point scale from 0 (none) to 4 (extreme or cannot do).
Total Range: 0-48 (Raw sum), where 0 is the minimum and 48 is maximum disability.
A higher score signifies a greater level of disability.
Measured: 56 days after surgery
Modeled opioid dosing trajectory
Individual trajectories, adjusted for prognostic covariates, of daily opioid dose in milligrams of morphine equivalents from daily diaries will be constructed using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling. The intercept is in opioid dose on the first post-discharge day and the slope is in units of logarithm of opioid dose per day with the lower number indicating slower quicker reduction in opioid dose over time.
Measured: 56 days after surgery
Modeled opioid cessation trajectory
: Individual trajectories, adjusted for prognostic covariates, of time to opioid cessation from daily diaries, in which each day is scored as taking opioids or not taking opioids. Opioid cessation for each individual is the last day they took an opioid. The trajectory for the likelihood of taking opioids will be determined using an intercept on the first postoperative day and a slope a log of time dimension through day 56 using growth curve modeling.
Measured: 56 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Douglas Ririe, M.D., Principal investigator, Wake Forest University School of Meidcine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430228
- Sponsor's protocol ID
- IRB00143862
- Other IDs
- 5P01NS119159-04
- Status last verified
- May 2026
- First submitted
- 18 Feb 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No