Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

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

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-02-28

Brief Summary

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It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sole local anesthetic

Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently

Group Type EXPERIMENTAL

Sole local anesthetic

Intervention Type DRUG

0.125% ropivacaine 10-15 ml every 1h during labor delivery

Ropivacaine

Intervention Type DRUG

Opioid plus local anesthetic

Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently

Group Type ACTIVE_COMPARATOR

Sufentanil (Opioid plus local anesthetic)

Intervention Type DRUG

Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery

Ropivacaine

Intervention Type DRUG

Interventions

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Sole local anesthetic

0.125% ropivacaine 10-15 ml every 1h during labor delivery

Intervention Type DRUG

Sufentanil (Opioid plus local anesthetic)

Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Other Intervention Names

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Ropivacaine Naropin Naropin

Eligibility Criteria

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Inclusion Criteria

* Nulliparas
* Request epidural analgesia
* Chinese

Exclusion Criteria

* Allergic to opioid or local anesthetics
* Fail to perform epidural puncture and catheterization
* Organ dysfunction
* Contraindications for epidural anesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No