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

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.

Study Overview

• Status: Unknown
• Conditions: Labor Analgesia
• Intervention / Treatment: Procedure: Epidural analgesia; Procedure: Continuous epidural infusion; Drug: ropivacaine; Drug: sufentanil; Procedure: Intermittent epidural bolus

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caijuan Li, M.A.; Phone Number: 025-52226112; Email: licaijuanyumi1228@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Recruiting
      • Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
      • Contact: Shanwu Feng, MD; Email: shanwufeng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Epidural analgesia; Procedure: Continuous epidural infusion; Drug: ropivacaine; Drug: sufentanil
Active Comparator: 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	Procedure: Epidural analgesia; Drug: ropivacaine; Drug: sufentanil; Procedure: Intermittent epidural bolus
Active Comparator: 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	Procedure: Epidural analgesia; Drug: ropivacaine; Drug: sufentanil; Procedure: Intermittent epidural bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal visual analogue scale (VAS)	a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"	At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)

Secondary Outcome Measures

Outcome Measure	Time Frame
Maternal modified Bromage scale	At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Subject's Satisfaction with labor epidural analgesia	At the time after childbirth
Total ropivacaine and sufentanil consumption	At two hours postpartum
Proportion of parturients requiring additional PCEA boluses	At two hours postpartum
Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale	At two hours postpartum
Maternal heart rate	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Rates of cesarean delivery and instrument-assisted delivery	At time of placental delivery
Duration of analgesia	Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Durations of labor stages	From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Use of oxytocin after analgesia	At twenty-four hours postpartum
Incidence of maternal side effects	Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Neonatal Apgar scale	At the first and fifth minutes after baby was born
Fetal heart rate	From initiation of analgesia to delivery (approximately 8 hours)
Neonatal weight	At delivery
Mean number of PCEA	At two hours postpartum
Maternal respiratory rate	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Maternal blood pressure	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

Collaborators and Investigators

• Sponsor: Nanjing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 27, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Sufentanil
• Other Study ID Numbers: NJFY2016002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No