Epidural Labor Analgesia and Infant Neurobehavior

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-07-31

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.

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Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Local anesthetic plus opioid 1

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.125% plus sufentanil 0.3 microgram

Local anesthetic plus opioid 2

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.125% plus sufentanil 0.4 microgram

Local anesthetic plus opioid 3

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.125% plus sufentanil 0.5 microgram

Local anesthetic 1 plus opioid

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.0625% plus sufentanil 0.4 microgram

Local anesthetic 2 plus opioid

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.1875% plus sufentanil 0.4 microgram

Local anesthetic 3 plus opioid

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

Group Type ACTIVE_COMPARATOR

Ropivacaine and sufentanil

Intervention Type DRUG

Ropivacaine 0.25% plus sufentanil 0.4 microgram

Interventions

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Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.3 microgram

Intervention Type DRUG

Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.4 microgram

Intervention Type DRUG

Ropivacaine and sufentanil

Ropivacaine 0.125% plus sufentanil 0.5 microgram

Intervention Type DRUG

Ropivacaine and sufentanil

Ropivacaine 0.0625% plus sufentanil 0.4 microgram

Intervention Type DRUG

Ropivacaine and sufentanil

Ropivacaine 0.1875% plus sufentanil 0.4 microgram

Intervention Type DRUG

Ropivacaine and sufentanil

Ropivacaine 0.25% plus sufentanil 0.4 microgram

Intervention Type DRUG

Other Intervention Names

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Naropin Sufenil Naropin Sufenil Naropin Sufenil Naropin Sufenil Naropin Sufenil Naropin Sufenil

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No