Clinical trial NCT06682416: The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
Official title: The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epidural Related Maternal Fever
Analgesia, Epidural
Fever
Intrapartum Fever
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 424
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

The study aims to determine if the temperature of local anesthetics influences the incidence of ERMF. It also seeks to assess the impact of anesthetic temperature on the onset and duration of epidural analgesia and various maternal and neonatal health outcomes. The findings may provide evidence on whether warming local anesthetics can reduce the risk of ERMF and improve maternal and neonatal health during labor.

Eligibility criteria: Inclusion Criteria:

1. Requesting epidural analgesia;
2. Aged 18 or older;
3. At least 37 weeks of gestation;
4. Those delivering vaginally.

Exclusion Criteria:

1. Contraindications to epidural analgesia;
2. Pre-existing fever (≥38°C) before labor;
3. Use of NSAIDs or other types of antipyretics before labor;
4. Multiple pregnancy (carrying more than one fetus);
5. Fetal demise (stillbirth);
6. Severe preeclampsia;
7. Women who refuse to participate.

Primary outcomes:
measure: Maternal fever incidence
timeFrame: 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.
Secondary outcomes:
measure: VAS ≤ 3
timeFrame: From date of receiving epidural anesthesia until the date of VAS ≤ 3, an average of 30 minutes
measure: Pulse Perfusion Index
timeFrame: Before epidural anesthesia, and at 10 minutes, 20 minutes, and 30 minutes after epidural catheterization.
measure: Maternal and Neonatal Antibiotic Use Rate
timeFrame: From the date of randomization until the date of first documented maternal or neonatal antibiotic use, assessed up to 1 month postoperatively.
measure: Incidence of bacteremia
timeFrame: From the date of randomization until the date of first documented bacteremia, assessed up to 1 month postoperatively.
measure: Intrapartum hypothermia
timeFrame: 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.
measure: Duration of labor
timeFrame: From the onset of labor until the delivery of the placenta, assessed up to 48 hours.
measure: Unplanned cesarean section rate
timeFrame: From date of randomization until the delivery of the placenta, assessed up to 48 hours.
measure: Umbilical Artery pH
timeFrame: up to 48 hours
measure: Apgar score at 1st and 5th minute for newborns
timeFrame: From the minute of fetal delivery until 5th minute post-delivery, assessed up to 5 minutes post-delivery.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Ethical Committee of the First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Fuhai Ji
role: PRINCIPAL_INVESTIGATOR
References: