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Enrolling by Invitation

NCT Number: NCT07430228

Efficacy of Intravenous Oxytocin to Speed Recovery After THA

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).

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Key information

Conditions

Total Hip Arthroplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous administration of oxytocin

Drug

Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.

Other names: Pitocin

Placebo

Drug

Saline will be administered intravenously over a period of 45 minutes

Other names: Saline

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Efficacy of Intravenous Oxytocin to Speed Recovery After Total Hip Arthroplasty

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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