Epidural Labor Analgesia and Infant Neurobehavior (ELAIN)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00987441
First received: September 30, 2009
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Labor Pain
Drug: Ropivacaine and sufentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epidural Analgesia for Labor Pain and Infant Neurobehavior

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: Immediate after birth (0 min) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Apgar scoring [ Time Frame: One min and 5min after birth. ] [ Designated as safety issue: Yes ]
  • Umbilical-cord gases analysis [ Time Frame: At the time baby was born (0min) ] [ Designated as safety issue: Yes ]
  • Neonatal sepsis evaluation [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Neonatal antibiotic treatment [ Time Frame: One hour after the baby was born ] [ Designated as safety issue: Yes ]
  • Incidence of maternal side effects [ Time Frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women) ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 10min after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 8h after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1d after birth ] [ Designated as safety issue: Yes ]
  • Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) [ Time Frame: 1wk after birth ] [ Designated as safety issue: Yes ]

Enrollment: 1200
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Local anesthetic plus opioid 1
Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.3 microgram
Other Names:
  • Naropin
  • Sufenil
Active Comparator: Local anesthetic plus opioid 2
Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Active Comparator: Local anesthetic plus opioid 3
Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.125% plus sufentanil 0.5 microgram
Other Names:
  • Naropin
  • Sufenil
Active Comparator: Local anesthetic 1 plus opioid
First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.0625% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Active Comparator: Local anesthetic 2 plus opioid
Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.1875% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil
Active Comparator: Local anesthetic 3 plus opioid
Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
Drug: Ropivacaine and sufentanil
Ropivacaine 0.25% plus sufentanil 0.4 microgram
Other Names:
  • Naropin
  • Sufenil

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987441

Locations
China, Jiangsu
The Affiliated Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00987441     History of Changes
Other Study ID Numbers: NJMU-0933MZ, NMUK2191
Study First Received: September 30, 2009
Last Updated: July 26, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Neurobehavior
Epidural analgesia
Local anesthetic
Opioid

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Ropivacaine
Anesthetics
Sufentanil
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on April 22, 2014