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

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Procedure: epidural needle; Procedure: 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 Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Department of Anesthesiology, Women's Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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),

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: epidural needle; the loading dose for labor analgesia administrated via epidural needle before the catheter insertion.	Procedure: epidural needle; the loading dose for labor analgesia administrated via epidural needle before the catheter insertion
Active Comparator: epidural catheter; the loading dose for labor analgesia administrated via the epidural catheter.	Procedure: epidural catheter; the loading dose for labor analgesia administrated via epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to onset of labor analgesia	Compare time of onset of labor analgesia and adequate analgesia was defined as VAS score<10mm in the presence of contraction.	8 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Study Director: Xinzhong Chen, Women's Hospital School of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: October 22, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: IRB-20220306-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No