Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

NCT04826120 | Completed

• 1 other identifier: Epidural in Labor
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Epidural; Analgesia

Keywords

Epidural, Analgesia, Labor, delivery

Outcome Measures

Primary Outcomes (1)

• Incidence of motor Blockage

  Bromage scale 1, 2 or 3

  during the epidural analgesia

Study Arms (2)

PCEA group

ACTIVE COMPARATOR

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

CEI Group

EXPERIMENTAL

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

Interventions

PCEA Infusion PROCEDURE

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

PCEA group

Continuous epidural infusion PROCEDURE

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

CEI Group

Eligibility Criteria

• Age: 17 Years+
• Gender Eligibility Details: parturients scheduled for vaginal delivery
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Full term parturients scheduled for vaginal delivery

You may not qualify if:

• patients in whom cesarean section delivery was indicated during labor

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (2)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

Mongi Slim Hospital

Tunis, 2046, Tunisia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of department of anesthesia and critical care

Model Details: parturients randomized in 2 groups and receiving 2 different interventions

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)