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Epidural Labor Analgesia and Infant Neurobehavior (ELAIN)

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ropivacaine and sufentanil
Ropivacaine and sufentanil
Ropivacaine and sufentanil
Ropivacaine and sufentanil
Ropivacaine and sufentanil
Ropivacaine and sufentanil
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring Neurobehavior, Epidural analgesia, Local anesthetic, Opioid

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • >18years and <45years
  • Spontaneous labor
  • Analgesia request

Exclusion Criteria:

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Using or used in the past 14 days of the monoamine oxidase inhibitors
  • Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  • Subjects with a nonvertex presentation or scheduled induction of labor

Sites / Locations

  • The Affiliated Nanjing Maternity and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Local anesthetic plus opioid 1

Local anesthetic plus opioid 2

Local anesthetic plus opioid 3

Local anesthetic 1 plus opioid

Local anesthetic 2 plus opioid

Local anesthetic 3 plus opioid

Arm Description

Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space

Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space

Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space

First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space

Outcomes

Primary Outcome Measures

Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

Secondary Outcome Measures

Apgar scoring
Umbilical-cord gases analysis
Neonatal sepsis evaluation
Neonatal antibiotic treatment
Incidence of maternal side effects
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)

Full Information

First Posted
September 30, 2009
Last Updated
July 26, 2011
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00987441
Brief Title
Epidural Labor Analgesia and Infant Neurobehavior
Acronym
ELAIN
Official Title
Epidural Analgesia for Labor Pain and Infant Neurobehavior
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Neurobehavior, Epidural analgesia, Local anesthetic, Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local anesthetic plus opioid 1
Arm Type
Active Comparator
Arm Description
Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space
Arm Title
Local anesthetic plus opioid 2
Arm Type
Active Comparator
Arm Description
Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
Arm Title
Local anesthetic plus opioid 3
Arm Type
Active Comparator
Arm Description
Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
Arm Title
Local anesthetic 1 plus opioid
Arm Type
Active Comparator
Arm Description
First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Arm Title
Local anesthetic 2 plus opioid
Arm Type
Active Comparator
Arm Description
Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Arm Title
Local anesthetic 3 plus opioid
Arm Type
Active Comparator
Arm Description
Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Intervention Type
Drug
Intervention Name(s)
Ropivacaine and sufentanil
Other Intervention Name(s)
Naropin, Sufenil
Intervention Description
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Primary Outcome Measure Information:
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
Immediate after birth (0 min)
Secondary Outcome Measure Information:
Title
Apgar scoring
Time Frame
One min and 5min after birth.
Title
Umbilical-cord gases analysis
Time Frame
At the time baby was born (0min)
Title
Neonatal sepsis evaluation
Time Frame
One hour after the baby was born
Title
Neonatal antibiotic treatment
Time Frame
One hour after the baby was born
Title
Incidence of maternal side effects
Time Frame
Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
10min after birth
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
1h after birth
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
8h after birth
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
1d after birth
Title
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time Frame
1wk after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: >18years and <45years Spontaneous labor Analgesia request Exclusion Criteria: Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records Participants younger than 18 years or older than 45 years Those who were not willing to or could not finish the whole study at any time Using or used in the past 14 days of the monoamine oxidase inhibitors Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics Subjects with a nonvertex presentation or scheduled induction of labor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Epidural Labor Analgesia and Infant Neurobehavior

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