RecruitingNot ApplicableNCT06682416

The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

424 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Fever Analgesia, Epidural Epidural Related Maternal Fever Intrapartum Fever

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria7

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.

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Interventions

PROCEDUREIn the context of epidural analgesia, the temperature of the local anesthetic solution is elevated to 37°C utilizing a blood transfusion and infusion warmer.

For the observation group, after reactivating the analgesic pump's exhaust procedure to clear the air from the tubing, the output tubing of the analgesic pump is first connected to the epidural catheter. Following this, a blood transfusion and infusion warmer (manufactured by Barkey GmbH \& Co. KG., Germany, model S-line, with the national medical device registration number 20182450063) is used to preheat the output tubing of the analgesic pump until it reaches the predetermined temperature of 37°C. For the control group, after reactivating the analgesic pump's exhaust procedure to remove air from the tubing, the output tubing of the analgesic pump is connected to the epidural catheter without preheating the output tubing using a blood transfusion and infusion warmer, maintaining room temperature (23°C).