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Completed

NCT Number: NCT04826120

Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

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).

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Key information

Conditions

Epidural; Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

17 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mongi Slim University Hospital, La Marsa, Tunis Governorate, Tunisia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Full term parturients scheduled for vaginal delivery

Exclusion criteria

  • patients in whom cesarean section delivery was indicated during labor

Treatment and study plan

PCEA Infusion

Procedure

Patients of this group Had PCEA during the second stage of labor

Continuous Epidural Infusion

Procedure

Patients of this group Had continuous epidural infusion during the second stage of labor

Primary outcomes

  1. Incidence of motor Blockage

    Time frame: during the epidural analgesia

    Bromage scale 1, 2 or 3

Sponsors and collaborators

Lead sponsor

Mongi Slim Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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