Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Not Applicable

Completed

• Conditions: Epidural; Analgesia
• Interventions: Procedure: PCEA Infusion; Procedure: Continuous epidural infusion

• Registration Number: NCT04826120
• Lead Sponsor: Mongi Slim Hospital

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).

Detailed Description

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).

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Full term parturients scheduled for vaginal delivery

Exclusion Criteria

• patients in whom cesarean section delivery was indicated during labor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCEA group	PCEA Infusion	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.
CEI Group	Continuous epidural infusion	Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.

Primary Outcome Measures

Name	Time	Method
Incidence of motor Blockage	during the epidural analgesia	Bromage scale 1, 2 or 3

Trial Locations

Locations (2)

Mongi Slim Hospital; 🇹🇳 Tunis, Tunisia

Mongi Slim University Hospital; 🇹🇳 La Marsa, Tunis, Tunisia