Continuous Versus Intermittent Administration of Epidural Analgesia During Labor
NCT ID: NCT04826120
Last Updated: 2021-04-01
Study Results
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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COMPLETED
NA
54 participants
INTERVENTIONAL
2020-06-01
2021-01-31
Brief Summary
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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).
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PCEA group
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.
PCEA Infusion
Patients of this group Had PCEA during the second stage of labor
CEI Group
Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.
Continuous epidural infusion
Patients of this group Had continuous epidural infusion during the second stage of labor
Interventions
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PCEA Infusion
Patients of this group Had PCEA during the second stage of labor
Continuous epidural infusion
Patients of this group Had continuous epidural infusion during the second stage of labor
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
17 Years
FEMALE
No
Sponsors
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Mongi Slim Hospital
OTHER
Responsible Party
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Mhamed Sami Mebazaa
Professor, head of department of anesthesia and critical care
Locations
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Mongi Slim University Hospital
La Marsa, Tunis Governorate, Tunisia
Mongi Slim Hospital
Tunis, , Tunisia
Countries
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Other Identifiers
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Epidural in Labor
Identifier Type: -
Identifier Source: org_study_id
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