Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Sponsor

Mongi Slim Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04826120

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Epidural; Analgesia	Procedure: PCEA Infusion Procedure: Continuous epidural infusion	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parturients randomized in 2 groups and receiving 2 different interventionsparturients randomized in 2 groups and receiving 2 different interventions

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: PCEA Infusion Patients of this group Had PCEA during the second stage of labor
Experimental: CEI Group 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 Patients of this group Had continuous epidural infusion during the second stage of labor

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: PCEA Infusion

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

Experimental: CEI Group

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

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

Outcome Measures

Primary Outcome Measures

Incidence of motor Blockage [during the epidural analgesia]
Bromage scale 1, 2 or 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Full term parturients scheduled for vaginal delivery

Exclusion Criteria:

patients in whom cesarean section delivery was indicated during labor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mongi Slim University Hospital	La Marsa	Tunis	Tunisia	2046
2	Mongi Slim Hospital	Tunis		Tunisia	2046

Sponsors and Collaborators

Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mhamed Sami Mebazaa, Professor, head of department of anesthesia and critical care, Mongi Slim Hospital

ClinicalTrials.gov Identifier:

NCT04826120

Other Study ID Numbers:

Epidural in Labor

First Posted:

Apr 1, 2021

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mhamed Sami Mebazaa, Professor, head of department of anesthesia and critical care, Mongi Slim Hospital

Epidural, Analgesia, Labor, delivery

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Apr 1, 2021