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Enrolling by invitation NCT07430228

Efficacy of Intravenous Oxytocin to Speed Recovery After THA

Phase II Interventional Total Hip Arthroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intravenous administration of oxytocin, Placebo.
Who it may be relevant to
Registry conditions: Total Hip Arthroplasty. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy of Intravenous Oxytocin to Speed Recovery After Total Hip Arthroplasty

Overview

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).

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).

Interventions

  • Drug intravenous administration of oxytocin
    Single administration of oxytocin 26 micrograms administered intravenously over a period of 45 minutes.
  • Drug Placebo
    Saline will be administered intravenously over a period of 45 minutes

Primary outcome measures

  • Modeled daily steps trajectory [Time frame: 56 days after surgery]
Secondary outcome measures (4)
  • Modeled pain intensity trajectory [Time frame: 56 days after surgery]
  • Modeled disability assessments [Time frame: 56 days after surgery]
  • Modeled opioid dosing trajectory [Time frame: 56 days after surgery]
  • Modeled opioid cessation trajectory [Time frame: 56 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Atrium Health Wake Forest Baptist — Winston-Salem

Identifiers

NCT: NCT07430228 · IRB00143862 · 5P01NS119159-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗