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Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

M

Mongi Slim Hospital

Status

Completed

Conditions

Epidural; Analgesia

Treatments

Procedure: Continuous epidural infusion
Procedure: PCEA Infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04826120
Epidural in Labor

Details and patient eligibility

About

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).

Full 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).

Enrollment

54 patients

Sex

Female

Ages

17+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Full term parturients scheduled for vaginal delivery

Exclusion criteria

  • patients in whom cesarean section delivery was indicated during labor

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

PCEA group
Active Comparator group
Description:
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.
Treatment:
Procedure: PCEA Infusion
CEI Group
Experimental group
Description:
Patients of this group had continuous epidural infusion at the rate of 8 ml/h during the second stage of labor.
Treatment:
Procedure: Continuous epidural infusion

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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