NCT04399707招募中不适用
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Post-operative narcotic consumption
研究概览
简要总结
Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women undergoing scheduled or non-urgent cesarean section
排除标准
- •Non-English speaking
- •Subjects with a history of chronic pain or chronic opioid use
- •Pre-operative use of opioids for more than 1 week in the preceding 6 months
- •Previous exposure to the TENS unit
- •Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
- •Subjects who had a midline vertical skin incision during this operation
- •Subjects who did not receive intrathecal opioids at the time of their cesarean delivery
- •Adhesive allergies
- •Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)
- •Intraoperative general anesthesia
- •Inability to consent to the study
- •Postpartum tubal ligation
结局指标
主要结局
Post-operative narcotic consumption
时间窗: First 60 hours post-operatively
Total postoperative narcotic consumption (measured in morphine equivalents)
次要结局
- Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)(On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month)
- Duration of hospitalization(From date of cesarean delivery until discharge from hospital, assessed up to 1 month)
- Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)(On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month)
- Adverse reactions to TENS unit(From date of randomization until date of discharge, assessed up to 1 month)
研究者
Kelly Yamasato, MD
Physician, Assistant Professor
Hawaii Pacific Health
研究点 (2)
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