Evidence map›Paper›PMID 41193197›Full record

ArticleBMJ open2025

Body-temperature versus room-temperature local anaesthetic solutions for epidural-related maternal fever prevention in labour: protocol for a two-centre randomised controlled trial.

Dapeng Chen, Qingge Wang, Qianyu Wu, Minhong Shen, Jisi Zhang, Xisheng Shan, Chang-Dong Feng, Huili Tang, Lei Wei, Fuhai Ji

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06682416 (The Impact of Local Anesthetic Solution Temperature on Epidural-related Maternal Fever), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06682416 narecruitingnot on this map

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

TypeinterventionalSponsorThe First Affiliated Hospital of Soochow UniversityRan2024 to 2027Enrolled424ConditionsEpidural Related Maternal Fever, Analgesia, Epidural, Fever, Intrapartum FeverArmsIn the context of epidural analgesia, the temperature of the local anesthetic solution is elevated to 37°C utilizing a blood transfusion and infusion warmer.
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Dapeng ChenAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China.ORCID http://orcid.org/0000-0002-6478-1243
Qingge WangObstetrics and Gynecology Department, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Qianyu WuAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China.
Minhong ShenObstetrics and Gynecology Department, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Jisi ZhangAnesthesiology, Suzhou Municipal Hospital, Suzhou, Jiangsu, China.
Xisheng ShanAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China.ORCID http://orcid.org/0000-0003-4779-1906
Chang-Dong FengAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China.
Huili TangAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China.
Lei WeiAnesthesiology, Suzhou Municipal Hospital, Suzhou, Jiangsu, China.
Fuhai JiAnesthsiology, First Affiliated Hospital of Soochow University, Suzhou, China jifuhai@suda.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpidural analgesia-related maternal fever (ERMF) affects 15%-25% of parturients, posing risks to both maternal and neonatal. Although ERMF's mechanisms remain unclear, non-infectious inflammatory responses and thermoregulatory disruption are implicated. Previous studies suggest that room-temperature local anaesthetic solutions administered during epidural analgesia may contribute to ERMF by altering spinal thermoregulation. This trial investigates whether warming local anaesthetic solutions to body temperature reduces ERMF incidence. METHODS AND ANALYSIS: This two-centre, double-blind, randomised controlled trial will enrol 424 parturients undergoing epidural analgesia for trial of labour. Participants will be randomised (1:1) to receive either body temperature (approximately 37°C) or room temperature (approximately 23°C) local anaesthetic solutions (0.1% ropivacaine with 0.5 µg/mL sufentanil). The primary outcome is intrapartum fever incidence, defined as oral temperature ≥38°C. Secondary outcomes include time to visual analogue scale ≤3, pulse perfusion index, maternal and neonatal antibiotic use rate, incidence of bacteraemia, intrapartum hypothermia, duration of labour, unplanned caesarean section rate, umbilical artery potential of hydrogen and Apgar scores at 1 and 5 min for newborns. Randomisation, stratified by study centre, employs permuted blocks via R software. Blinding is maintained for participants, outcome assessors and statisticians. A sample size of 424 participants (212 per group) provides 80% power (α=0.05) to detect a reduction in fever incidence from 21% to 10%. The primary analysis will be conducted in accordance with the intention-to-treat principle, with a secondary per-protocol analysis. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2023367-2) and the Ethics Committee of Suzhou Municipal Hospital (Approval No. K-2024-258 K01), and adheres to the Declaration of Helsinki. All participants will provide written informed consent. Results will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06682416.

Indexed as

Analgesia, EpiduralAnalgesia, ObstetricalAnesthetics, LocalBody TemperatureFeverAdultDouble-Blind MethodFemaleHumansMulticenter Studies as TopicPregnancyRandomized Controlled Trials as TopicRopivacaineAnesthetics, LocalRopivacaineAnaesthesia in obstetricsANAESTHETICSMaternal medicineRandomized Controlled Trial

Identifiers

PMID41193197
PMCPMC12588007

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.