Efficacy of Intravenous Oxytocin to Speed Recovery After THA

Phase 2Enrolling By InvitationNCT07430228

Wake Forest University Health Sciences80 enrolled

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).

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Total Hip Arthroplasty

Interventions

intravenous administration of oxytocinDRUG

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

PlaceboDRUG

Saline will be administered intravenously over a period of 45 minutes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 56 days after surgery

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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