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Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Continuous Versus Intermittent Administration of Epidural Analgesia During Labor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04826120
Enrollment
54
Registered
2021-04-01
Start date
2020-06-01
Completion date
2021-01-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural; Analgesia

Keywords

Epidural, Analgesia, Labor, delivery

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).

Interventions

PROCEDUREPCEA Infusion

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

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

Sponsors

Mongi Slim Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

parturients randomized in 2 groups and receiving 2 different interventions

Eligibility

Sex/Gender
FEMALE
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Full term parturients scheduled for vaginal delivery

Exclusion criteria

* patients in whom cesarean section delivery was indicated during labor

Design outcomes

Primary

MeasureTime frameDescription
Incidence of motor Blockageduring the epidural analgesiaBromage scale 1, 2 or 3

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026