Epidural Labor Analgesia and Infant Neurobehavior

Study Overview
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Brief Summary
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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.

Official Title
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Epidural Analgesia for Labor Pain and Infant Neurobehavior

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Ropivacaine and sufentanil
* Drug: Ropivacaine and sufentanil
* Drug: Ropivacaine and sufentanil
* Drug: Ropivacaine and sufentanil
* Drug: Ropivacaine and sufentanil
* Drug: Ropivacaine and sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local anesthetic plus opioid 1<br>Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.125% plus sufentanil 0.3 microgram<br>* Other names: Sufenil;|
| Active Comparator: Local anesthetic plus opioid 2<br>Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.125% plus sufentanil 0.4 microgram<br>* Other names: Sufenil;|
| Active Comparator: Local anesthetic plus opioid 3<br>Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.125% plus sufentanil 0.5 microgram<br>* Other names: Sufenil;|
| Active Comparator: Local anesthetic 1 plus opioid<br>First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.0625% plus sufentanil 0.4 microgram<br>* Other names: Sufenil;|
| Active Comparator: Local anesthetic 2 plus opioid<br>Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.1875% plus sufentanil 0.4 microgram<br>* Other names: Sufenil;|
| Active Comparator: Local anesthetic 3 plus opioid<br>Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space | Drug: Ropivacaine and sufentanil<br>* Ropivacaine 0.25% plus sufentanil 0.4 microgram<br>* Other names: Sufenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | Immediate after birth (0 min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 10min after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1h after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 8h after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1d after birth | 
| Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) |  | 1wk after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurobehavior, Epidural analgesia, Local anesthetic, Opioid