Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia for Pain Management During Labor

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-20

Study Completion Date

2019-07-20

Brief Summary

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The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.

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Detailed Description

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Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.

Conditions

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Labor Long Labor Pain Labor Fetal Anoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants who request neuraxial labor analgesia are randomly assigned into two groups by a computer-generated random number table using Excel. One group received combined spinal-epidural analgesia during labor, the other group received epidural analgesia during labor.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

One anesthetist who were not involved with clinical care or data collection performed the randomization procedure and the neuraxial block according to the group allocation. The other anesthetist blinds to the procedure preform the analgesia management after neuraxial block. This anesthetist and the obstetrician, the midwives, the patients , the outcomes collector and assessor are all blind to group allocation throughout.

Study Groups

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Combined spinal-epidural analgesia

The combined spinal epidural analgesia technique was used to maintain analgesia for parturients in the combined spinal-epidural analgesia group. First, the investigator injected a dose of 5 ug sufentanil into cerebrospinal fluid. If no adverse effects were observed 10 minutes after the first dose, the parturient then received mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate through a patient-controlled epidural analgesia (PCA) pump, which provided patients themixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.

Group Type EXPERIMENTAL

Combined spinal-epidural analgesia

Intervention Type PROCEDURE

Combined spinal-epidural analgesia during labor is a labor analgesia technique which reported maybe associate with a shorter labor duration compared to the traditional epidural labor analgesia.

Epidural analgesia

The epidural analgesia technique was used to maintain analgesia for parturients in the epidural analgesia group, which involved placing a thin catheter through a needle inserted into the epidural space. First, the investigator injected a test dose of 5ml 1% lidocaine through it. If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.

Group Type OTHER

Epidural analgesia

Intervention Type PROCEDURE

Epidural analgesia is a well-accepted technique using for pain relief during labor.

Interventions

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Combined spinal-epidural analgesia

Combined spinal-epidural analgesia during labor is a labor analgesia technique which reported maybe associate with a shorter labor duration compared to the traditional epidural labor analgesia.

Intervention Type PROCEDURE

Epidural analgesia

Epidural analgesia is a well-accepted technique using for pain relief during labor.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.

Exclusion Criteria

* Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No