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

Primary Purpose

Labor Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Epidural analgesia
Continuous epidural infusion
Intermittent epidural bolus
ropivacaine
sufentanil
Sponsored by
Nanjing Maternity and Child Health Care Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Analgesia

Eligibility Criteria

22 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

CEI

PIEB 1

PIEB 2

Arm 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

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

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

Outcomes

Primary Outcome Measures

Maternal visual analogue scale (VAS)
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"

Secondary Outcome Measures

Maternal modified Bromage scale
Subject's Satisfaction with labor epidural analgesia
Total ropivacaine and sufentanil consumption
Proportion of parturients requiring additional PCEA boluses
Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale
Maternal heart rate
Rates of cesarean delivery and instrument-assisted delivery
Duration of analgesia
Durations of labor stages
Use of oxytocin after analgesia
Incidence of maternal side effects
Neonatal Apgar scale
Fetal heart rate
Neonatal weight
Mean number of PCEA
Maternal respiratory rate
Maternal blood pressure

Full Information

First Posted
August 11, 2016
Last Updated
December 27, 2016
Sponsor
Nanjing Maternity and Child Health Care Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02873091
Brief Title
Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
Official Title
Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Maternity and Child Health Care Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CEI
Arm Type
Active Comparator
Arm 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
Arm Title
PIEB 1
Arm Type
Active Comparator
Arm 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
Arm Title
PIEB 2
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Epidural analgesia
Intervention Type
Procedure
Intervention Name(s)
Continuous epidural infusion
Intervention Type
Procedure
Intervention Name(s)
Intermittent epidural bolus
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Type
Drug
Intervention Name(s)
sufentanil
Primary Outcome Measure Information:
Title
Maternal visual analogue scale (VAS)
Description
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"
Time Frame
At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)
Secondary Outcome Measure Information:
Title
Maternal modified Bromage scale
Time Frame
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Title
Subject's Satisfaction with labor epidural analgesia
Time Frame
At the time after childbirth
Title
Total ropivacaine and sufentanil consumption
Time Frame
At two hours postpartum
Title
Proportion of parturients requiring additional PCEA boluses
Time Frame
At two hours postpartum
Title
Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale
Time Frame
At two hours postpartum
Title
Maternal heart rate
Time Frame
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Title
Rates of cesarean delivery and instrument-assisted delivery
Time Frame
At time of placental delivery
Title
Duration of analgesia
Time Frame
Initiation of analgesia to 2 h postpartum (approximately 10 hours)
Title
Durations of labor stages
Time Frame
From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)
Title
Use of oxytocin after analgesia
Time Frame
At twenty-four hours postpartum
Title
Incidence of maternal side effects
Time Frame
Initiation of analgesia to 2 hour postpartum (approximately 10 hours)
Title
Neonatal Apgar scale
Time Frame
At the first and fifth minutes after baby was born
Title
Fetal heart rate
Time Frame
From initiation of analgesia to delivery (approximately 8 hours)
Title
Neonatal weight
Time Frame
At delivery
Title
Mean number of PCEA
Time Frame
At two hours postpartum
Title
Maternal respiratory rate
Time Frame
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Title
Maternal blood pressure
Time Frame
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caijuan Li, M.A.
Phone
025-52226112
Email
licaijuanyumi1228@126.com
Facility Information:
Facility Name
Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanwu Feng, MD
Email
shanwufeng@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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