Efficacy of Intravenous Oxytocin to Speed Recovery After Total Hip Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modeled daily steps trajectory
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo administered intravenously
干预措施: Placebo (Drug)
Oxytocin
Oxytocin 26 micrograms administered intravenously
干预措施: intravenous administration of oxytocin (Drug)
结局指标
主要结局
Modeled daily steps trajectory
时间窗: 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.
次要结局
- 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)