Comparative Study of the Loading Dose Administrated Via Epidural Needle or Epidural Catheter for Labor Analgesia

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Procedure: epidural needle; Procedure: epidural catheter

• Registration Number: NCT05594771
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

Epidural anesthesia (EP) is widely used for labor analgesia. Time to onset of adequate pain relief of EP technique for labor analgesia may be 15 to 20 minutes.More rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.There is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.

Detailed Description

The epidural analgesia was performed in the left lateral decubitus position at the L3-L4 or L2-L3 interspace using a 18 G Tuohy needle. The epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique.

In the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. In the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group N.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-26
• Study Start: 2022-11-15
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 276

Inclusion Criteria

1. healthy, term (37-42 weeks' gestation),
2. nulliparous women with singleton
3. patients in active labor with a cervical dilation <5cm who planned labor analgesia

Exclusion Criteria

1. any contraindication to neuraxial anesthesia,

2. body mass index>50kg/m2,

3. VAS <50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia),

4. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
epidural needle	epidural needle	the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.
epidural catheter	epidural catheter	the loading dose for labor analgesia administrated via the epidural catheter.

Primary Outcome Measures

Name	Time	Method
The time to onset of labor analgesia	8 months	Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score\<10mm in the presence of contraction.

Secondary Outcome Measures

Name	Time	Method
VSA scores	8 months	the Visual Analog Scale (VAS) on a 100-mm scale is measured during the labor .
number of PCEA bolus requests	8 months	the numbers of the patient -controlled epidural anangesia(PCEA) bolus of 5 ml with 15 minute lockout.
analgesia drug ( ropivacaine) requests	8 months	The total ropivacaine dose is recorded and is divided by the hours.

Trial Locations

Locations (1)

Department of Anesthesiology, Women's Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China