DRUG
intravenous administration of oxytocin
Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.
Status
Enrolling by invitation
Phase
Phase 2
Enrollment
80
Locations
1
Results
Not posted
Publications
0
Study 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).
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).
Interventions
DRUG
Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.
DRUG
Saline will be administered intravenously over a period of 45 minutes
Timeline
First posted
Feb 24, 2026
Study start
Aug 2026
Primary completion
Dec 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 28, 2026
Outcomes
Modeled daily steps trajectory
Time frame · 56 days after surgery
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.
Modeled pain intensity trajectory
Time frame · 56 days after surgery
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
Modeled disability assessments
Time frame · 56 days after surgery
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.
Modeled opioid dosing trajectory
Time frame · 56 days after surgery
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.
Modeled opioid cessation trajectory
Time frame · 56 days after surgery
: 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.
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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