Epidural Analgesia During Labour

Phase 3

Completed

• Conditions: Anesthesia, Obstetrical; Analgesia, Epidural

• Registration Number: NCT03133091
• Lead Sponsor: Hospital del Río Hortega

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery	Change from baseline in Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
Bromage Scale	15 minutes after Epidural Block and 1 hour after epidural block
Labour Outcome	Delivery	cesarean section
Apgar at birth	5 minutes after birth	Apgar measured in 5 minutes
fetal pH at birth	0 minutes after delivery	0 minutes after delivery
Satisfaction (Likert Scale)	1 hour after delivery	1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)
Expulsive time	From 10 cm of dilatation until delivery
Total Dosis of Levobupivacaine	0 minutes after delivery	miligrams

Trial Locations

Locations (1)

Hospital Universitario Rio Hortega; 🇪🇸 Valladolid, Spain