Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope
研究概览
简要总结
The purpose of this study is to determine the effect of intrathecal oxytocin on speed of reduction in pain for the first 60 days after hip surgery.
详细描述
This is a single-center, NIH funded clinical study at Wake Forest Baptist Medical Center. The investigators anticipate that intrathecal oxytocin will speed recovery from pain after major surgery (hip arthroplasty). For this study, the investigators will use a randomized, controlled and blinded study of intrathecal oxytocin in patients scheduled for hip arthroplasty, with primary outcome being the slope of change in pain over the first 60 days following surgery, using growth curve modeling and a ln(time) function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for unilateral, primary total hip replacement
- •American Society of Anesthesiologists physical status 1-3
排除标准
- •Pregnancy
- •Currently Workman's Comp litigation related to hip replacement
- •Taking greater than 100 milligrams of morphine (or equivalent)
- •Suffering from a psychotic disorder or a recent psychiatric hospitalization
研究组 & 干预措施
Oxytocin
Oxytocin 100 micrograms administered intrathecally
干预措施: Oxytocin (Drug)
Placebos
Placebo injection administered intrathecally
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Slope
时间窗: Postoperative Day 1 through Postoperative Day 60
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Slope is defined as change in pain . Values represent the slope of modeled worst daily pain (0-10 scale as described above) divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
Comparison of Adjusted Trajectory Model for Pain Between Oxytocin and Placebo--Intercept
时间窗: The first day after hospital discharge
Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for oxytocin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain. Values represent an intercept of modeled worst daily pain on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model.
次要结局
- Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Intercept(The first day after hospital discharge)
- Comparison of Adjusted Trajectory Model for Daily Steps Between Oxytocin and Placebo--Slope(Postoperative Day 1 through Postoperative Day 60)
- Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Slope(Postoperative Day 7 through Postoperative Day 56)
- Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Intercept(The first day after hospital discharge)
- Iowa Gambling Task(Preoperative, 2 months after surgery)
- Tampa Scale of Kinesiophobia(Preoperative, 2 months after surgery)
- Comparison of Adjusted Trajectory Model for Probability of Taking Opioids Daily Between Oxytocin and Placebo--Slope(Postoperative Day 1 through Postoperative Day 60)
- Wisconsin Card Sort Task(Preoperative, 2 months after surgery)
- Comparison of Adjusted Trajectory Model for World Health Organization Disability Assessment Score 2.0 Value Between Oxytocin and Placebo--Intercept(Modeled WHODAS 2.0 one week after hospital discharge)