Health TrialsbyHealthPanel

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

ConditionsEpidural Related Maternal FeverAnalgesia, EpiduralFeverIntrapartum Fever
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Requesting epidural analgesia;

Aged 18 or older;

At least 37 weeks of gestation;

Those delivering vaginally.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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).

Treatment groups

424 Participants
are divided into 2 treatment groups
Group A: Observation groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Maternal fever incidence

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.

Time frame
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

1

VAS ≤ 3

The Visual Analogue Scale (VAS) is a simple tool for assessing pain intensity. It features a 100mm line with "0" at one end indicating no pain and "10" at the other end representing the worst possible pain. Patients mark their pain level anywhere along the line, providing a continuous measure of their discomfort.

Time frame
From date of receiving epidural anesthesia until the date of VAS ≤ 3, an average of 30 minutes
2

Pulse Perfusion Index

Time frame
Before epidural anesthesia, and at 10 minutes, 20 minutes, and 30 minutes after epidural catheterization.
3

Maternal and Neonatal Antibiotic Use Rate

Querying the electronic medical record system for antibiotic usage

Time frame
From the date of randomization until the date of first documented maternal or neonatal antibiotic use, assessed up to 1 month postoperatively.
4

Incidence of bacteremia

The proportion of positive bacterial culture test results in each group.

Time frame
From the date of randomization until the date of first documented bacteremia, assessed up to 1 month postoperatively.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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