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

NCT06682416 | Recruiting

• 1 other identifier: 2023367
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 2

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.

Conditions

Epidural Related Maternal Fever; Analgesia, Epidural; Fever; Intrapartum Fever

Outcome Measures

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.

  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 (9)

• 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.

Study Arms (2)

Observation group

EXPERIMENTAL

Participants will be assigned to receive 37°C local anesthetic solutions.

Procedure: 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.

Control group

NO INTERVENTION

Participants will be assigned to receive 23°C local anesthetic solutions.

Interventions

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

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).

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (2)

Ethical Committee of the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

NOT YET RECRUITING

Related Publications (1)

• Chen D, Wang Q, Wu Q, Shen M, Zhang J, Shan X, Feng CD, Tang H, Wei L, Ji F. Body-temperature versus room-temperature local anaesthetic solutions for epidural-related maternal fever prevention in labour: protocol for a two-centre randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101760. doi: 10.1136/bmjopen-2025-101760.

  PMID: 41193197 DERIVED

MeSH Terms

Conditions

Agnosia; Fever

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Study Officials

• Fuhai Ji

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dapeng Chen

CONTACT

+8618550044050; hisoka52@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, department of anesthesiology

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)