Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Study Overview
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Brief Summary
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prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups. Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group).

Detailed Description
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prospective randomized single blind study, including full term adult parturients, ASA 2, 3 status, scheduled for vaginal delivery. patients were randomized at 3 cm of cervix dilatation, into 2 groups. Epidural analgesia was initiated and maintained with a solution of Bupivacaine 0,125% and Sufentanil 0,25 mcg/ml. After an initial bolus of 16 ML, patients were randomly assigned to receive intermittent boluses of 8 ml every 60 minutes after the initial dose followed by supplementary PCEA boluses of 8 ml for the first group ( PCEA group) or a continuous epidural infusion at the rate of 8 ml/h adjustable and starting immediately after The initial bolus of 16 ml for patients of the second group (CEI Group). The main outcome of this study was: the incidence of motor Blockage. Our secondary outcomes were: maternal satisfaction, local anaesthetic and sufentanil cumulated doses, duration of the second stage of labor, mode of delivery and pain during labor using the Visual analogic score (VAS score).

Official Title
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Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Conditions
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Epidural; Analgesia

Intervention / Treatment
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* Procedure: PCEA Infusion
* Procedure: Continuous epidural infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term parturients scheduled for vaginal delivery Exclusion Criteria: patients in whom cesarean section delivery was indicated during labor

Ages Eligible for Study
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Minimum Age: 17 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
Interventional Model Description: parturients randomized in 2 groups and receiving 2 different interventions
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCEA group<br>Patients of this group had intermittent epidural analgesia via PCEA associated to systematic 8 ml boluses every 60 min during the second stage of labor. | Procedure: PCEA Infusion<br>* Patients of this group Had PCEA during the second stage of labor<br>|
| Experimental: CEI Group<br>Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor. | Procedure: Continuous epidural infusion<br>* Patients of this group Had continuous epidural infusion during the second stage of labor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of motor Blockage | Bromage scale 1, 2 or 3 | during the epidural analgesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural, Analgesia, Labor, delivery