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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594771
• Other study ID #: IRB-20220306-R
• Status: Completed
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• epidural needle
the loading dose for labor analgesia administrated via epidural needle before the catheter insertion
• epidural catheter
the loading dose for labor analgesia administrated via epidural catheter

Locations

Country	Name	City	State
China	Department of Anesthesiology, Women's Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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