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

N

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

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

Trial contacts and locations

1

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Central trial contact

Caijuan Li, M.A.

Data sourced from clinicaltrials.gov

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