Epidural Labor Analgesia and Infant Neurobehavior

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: Ropivacaine and sufentanil

• Registration Number: NCT00987441
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Status Verified: 2011-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-26
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local anesthetic 3 plus opioid	Ropivacaine and sufentanil	Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Local anesthetic plus opioid 2	Ropivacaine and sufentanil	Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
Local anesthetic plus opioid 3	Ropivacaine and sufentanil	Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
Local anesthetic 1 plus opioid	Ropivacaine and sufentanil	First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Local anesthetic 2 plus opioid	Ropivacaine and sufentanil	Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Local anesthetic plus opioid 1	Ropivacaine and sufentanil	Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space

Primary Outcome Measures

Name	Time	Method
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	Immediate after birth (0 min)

Secondary Outcome Measures

Name	Time	Method
Apgar scoring	One min and 5min after birth.
Umbilical-cord gases analysis	At the time baby was born (0min)
Neonatal sepsis evaluation	One hour after the baby was born
Neonatal antibiotic treatment	One hour after the baby was born
Incidence of maternal side effects	Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	1wk after birth

Trial Locations

Locations (1)

The Affiliated Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China