NCT05446636招募中不适用
Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2023年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Incidence of moderate and severe pain after cesarean section
研究概览
简要总结
Use huawei wristwatch to record maternal rhythm status and record the VAS score after cesarean section under combined spinal-epidural anesthesia. Based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 45
- •ASA(American society of anesthesiologists) status II-III
- •37-42 weeks gestation
- •undergo elective cesarean section with subarachnoid anesthesia
- •participate in this study and sign informed consent
排除标准
- •Patients with contraindications of combined spinal and epidural anesthesia
- •Patients with severe systemic disease
- •Alcoholism and long-term use of anti-inflammatory and analgesic drugs
- •Patients who were unable to cooperate or refused to participate in the trial
- •with psychiatric disorder
- •researchers considered unsuitable to participate in or unable to cooperate with the study
结局指标
主要结局
Incidence of moderate and severe pain after cesarean section
时间窗: From ending of the surgery to 24hours after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain) \>4
次要结局
- Pain intensity durig 6 to 12 hours after surgery(From 6 hours after cesarean section to 12 hours after cesarean section)
- Body temperature variability(From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week)
- Percentage of deep sleep(From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week)
- Pain intensity durig 0 to 6 hours after surgery(From ending of the surgery to 6 hours after cesarean section)
- Pain intensity durig 12 to 24 hours after surgery(From 12 hours after cesarean section to 24 hours after cesarean section)
- Variability of patients' activity(From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week)
- Heart rate variability(From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week)
- Percentage of rapid eye movement sleep(From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week)
研究者
研究点 (1)
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