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Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia

NCT ID: NCT02873091

Last Updated: 2016-12-28

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

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-10-31

Brief Summary

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Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (\<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.

Detailed Description

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Conditions

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Labor Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CEI

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Continuous epidural infusion

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sufentanil

Intervention Type DRUG

PIEB 1

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sufentanil

Intervention Type DRUG

PIEB 2

Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sufentanil

Intervention Type DRUG

Interventions

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Epidural analgesia

Intervention Type PROCEDURE

Continuous epidural infusion

Intervention Type PROCEDURE

Intermittent epidural bolus

Intervention Type PROCEDURE

ropivacaine

Intervention Type DRUG

sufentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who agree to join this study
* Age: 22y-40y
* American Society of Anesthesiologists (ASA) physical status 1 or 2
* Gestation : 37-41 weeks
* Primipara
* Singleton fetus and head presentation
* In early labor: cervical dilation for 1-3cm
* Requesting labor epidural analgesia

Exclusion Criteria

* Contraindication for epidural analgesia
* Height less than 150 cm or more than 170 cm
* Morbid obesity (BMI more than 35)
* High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
* Received parenteral opioids
* Unable to perform motor block evaluation tests
Minimum Eligible Age

22 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Maternity and Child Health Care Hospital

OTHER

Sponsor Role lead

Responsible Party

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Caijuan Li

Nanjing Maternity and Child Health Care Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Caijuan Li, M.A.

Role: CONTACT

Phone: 025-52226112

Email: [email protected]

Facility Contacts

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Shanwu Feng, MD

Role: primary

Other Identifiers

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NJFY2016002

Identifier Type: -

Identifier Source: org_study_id