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

Nanjing Medical University

Status: Unknown

Conditions: Labor Analgesia

Treatments: Procedure: Intermittent epidural bolus; Drug: ropivacaine; Procedure: Continuous epidural infusion; Procedure: Epidural analgesia; Drug: sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02873091

NJFY2016002

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: Female

Ages: 22 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 3 patient groups

CEI

Active Comparator group

Description:

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

Treatment:

Procedure: Continuous epidural infusion

Drug: ropivacaine

Drug: sufentanil

Procedure: Epidural analgesia

PIEB 1

Active Comparator group

Description:

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

Treatment:

Procedure: Intermittent epidural bolus

Drug: ropivacaine

Drug: sufentanil

Procedure: Epidural analgesia

PIEB 2

Active Comparator group

Description:

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

Treatment:

Procedure: Intermittent epidural bolus

Drug: ropivacaine

Drug: sufentanil

Procedure: Epidural analgesia