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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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epidural needle

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

Group Type EXPERIMENTAL

epidural needle

Intervention Type PROCEDURE

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

epidural catheter

the loading dose for labor analgesia administrated via the epidural catheter.

Group Type ACTIVE_COMPARATOR

epidural catheter

Intervention Type PROCEDURE

the loading dose for labor analgesia administrated via epidural catheter

Interventions

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epidural needle

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

Intervention Type PROCEDURE

epidural catheter

the loading dose for labor analgesia administrated via epidural catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No