The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Maternal fever incidence
研究概览
简要总结
This study investigates how the temperature of local anesthetics affects maternal fever related to epidural analgesia during childbirth. The research is a prospective, randomized controlled trial involving 424 participants from two hospitals. The primary objective is to investigate the impact of local anesthetic solution temperature on intrapartum fever in parturients. Secondary goals include assessing the impact on the efficacy of epidural analgesia and various maternal and neonatal outcomes. Participants will receive either 37°C or 23°C anesthetic solutions, and data will be collected on fever rates, pain scores, and other health indicators. The study runs from January 2024 to December 2026.
详细描述
Background:
Maternal fever during labor is common, with an incidence of about 33%, often due to infection, epidural analgesia, or environmental factors. Multiple studies have indicated that the rate of intrapartum fever in women who receive epidural analgesia is approximately between 15% and 25%. After epidural analgesia, the risk of maternal fever significantly increases, a condition known as Epidural-Related Maternal Fever (ERMF). ERMF not only increases unnecessary antibiotic use but may also lead to unplanned cesarean sections, increased perinatal bleeding, and other complications. Moreover, any cause of intrapartum fever, including ERMF, can increase the incidence of neonatal brain injury by approximately 2.79 times. With the popularization of the concept of painless childbirth, ERMF has increasingly attracted people's attention. Despite being identified in 1989, the pathogenesis of ERMF remains unclear, with several mechanisms proposed, including infection, sympathetic blockade, and non-infectious inflammation induced by local anesthetics.
Methods:
This is a prospective randomized controlled study with 424 participants receiving epidural analgesia at two hospitals from October 2024 to October 2027. Participants will be randomly assigned to receive either 37°C or 23°C local anesthetic solutions. The study will measure maternal fever rates, the time for pain scores to decrease, and peripheral perfusion index at various intervals. Maternal and neonatal outcomes, including antibiotic usage, sepsis incidence, and Apgar scores, will be recorded.
Possible Conclusions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Requesting epidural analgesia;
- •Aged 18 or older;
- •At least 37 weeks of gestation;
- •Those delivering vaginally.
排除标准
- •Contraindications to epidural analgesia;
- •Pre-existing fever (≥38°C) before labor;
- •Use of NSAIDs or other types of antipyretics before labor;
- •Multiple pregnancy (carrying more than one fetus);
- •Fetal demise (stillbirth);
- •Severe preeclampsia;
- •Women who refuse to participate.
结局指标
主要结局
Maternal fever incidence
时间窗: Before epidural catheterization, and at 2, 4, and 6 hours after epidural catheterization, and at the end of the second and third stages of labor, and 1 hour postpartum.
The primary outcome measure for this trial is the incidence of maternal fever, as determined by oral temperature readings, throughout the entire labor process. Maternal fever is defined as maternal intrapartum fever with a temperature of 38°C or higher.
次要结局
- VAS ≤ 3(From date of receiving epidural anesthesia until the date of VAS ≤ 3, an average of 30 minutes)
- Pulse Perfusion Index(Before epidural anesthesia, and at 10 minutes, 20 minutes, and 30 minutes after epidural catheterization.)
- Maternal and Neonatal Antibiotic Use Rate(From the date of randomization until the date of first documented maternal or neonatal antibiotic use, assessed up to 1 month postoperatively.)
- Incidence of bacteremia(From the date of randomization until the date of first documented bacteremia, assessed up to 1 month postoperatively.)
- Intrapartum hypothermia(Before epidural catheterization, and at 2, 4, and 6 hours after epidural catheterization, and at the end of the second and third stages of labor, and 1 hour postpartum.)
- Duration of labor(From the onset of labor until the delivery of the placenta, assessed up to 48 hours.)
- Unplanned cesarean section rate(From date of randomization until the delivery of the placenta, assessed up to 48 hours.)
- Umbilical Artery pH(up to 48 hours)
- Apgar score at 1st and 5th minute for newborns(From the minute of fetal delivery until 5th minute post-delivery, assessed up to 5 minutes post-delivery.)
研究者
Fuhai Ji
Director, department of anesthesiology
The First Affiliated Hospital of Soochow University