Efficacy of Intravenous Oxytocin to Speed Recovery After THA

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Drug: intravenous administration of oxytocin; Drug: Placebo

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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered intravenously	Drug: Placebo; Saline will be administered intravenously over a period of 45 minutes; Other Names: Saline
Experimental: Oxytocin; Oxytocin 26 micrograms administered intravenously	Drug: intravenous administration of oxytocin; Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.; Other Names: Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	56 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	56 days after surgery

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Douglas Ririe, M.D., Wake Forest University School of Meidcine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; Disability; Intravenous (IV) oxytocin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Chlorides; Hydrochloric Acid; Oxytocin; Sodium Chloride
• Other Study ID Numbers: IRB00143862; 5P01NS119159-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No