Epidural Analgesia During Labour

Hospital del Rio Hortega200 enrolled

Overview

Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Anesthesia, Obstetrical Analgesia, Epidural

Interventions

PIEB: Patient Intermittent Epidural BolusesDRUG

Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).

PCEA: Patient Controlled Epidural AnalgesiaDRUG

Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20- 40 years-old women * Primiparous women * Dilatation 3- 7 cm * No risk illnesses for epidural block * No risk pregnancy * Signed informed consent Exclusion Criteria: * Illnesses which are a risk for pregnancy * Multiparous women * Contraindicated diseases for epidural block * Women who can not understand the procedure * Women who do not want to sign the informed consent * Patients with drug´s allergy

Locations (1)

Hospital Universitario Rio Hortega

Valladolid, Spain

Outcomes

Primary Outcomes

VAS

Change from baseline in Visual Analog Scale

Time frame: 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery

Secondary Outcomes

Satisfaction (Likert Scale)

1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)

Time frame: 1 hour after delivery

Bromage Scale

Time frame: 15 minutes after Epidural Block and 1 hour after epidural block

Labour Outcome

Eutocic

Time frame: Delivery

Labour Outcome

instrumental

Time frame: Delivery

Labour Outcome

cesarean section

Time frame: Delivery

Expulsive time

Time frame: From 10 cm of dilatation until delivery

Apgar at birth

Apgar measured in 1 minute

Time frame: 1 minute after birth

Apgar at birth

Apgar measured in 5 minutes

Time frame: 5 minutes after birth

fetal pH at birth

0 minutes after delivery

Data from ClinicalTrials.gov

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