Efficacy of Intravenous Oxytocin to Speed Recovery After THA

NCT07430228 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB001438625P01NS119159-04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Total Hip Arthroplasty

Keywords

Intravenous (IV) oxytocin; Postoperative pain; Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Modeled pain intensity trajectory

  56 days after surgery

• Modeled disability assessments

  56 days after surgery

• Modeled opioid dosing trajectory

  56 days after surgery

• Modeled opioid cessation trajectory

  56 days after surgery

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin 26 micrograms administered intravenously

Drug: intravenous administration of oxytocin

Placebo

PLACEBO COMPARATOR

Placebo administered intravenously

Drug: Placebo

Interventions

intravenous administration of oxytocin DRUG

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

Also known as: Pitocin

Oxytocin

Placebo DRUG

Saline will be administered intravenously over a period of 45 minutes

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Douglas Ririe, M.D.

  Wake Forest University School of Meidcine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas Ririe, M.D.

CONTACT

336-716-4498; douglas.ririe@advocatehealth.org

Regina Curry, R.N.

CONTACT

336-716-4294; regina.curry@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)