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Epidural Analgesia During Labour

NCT03133091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-08-06

No results posted yet for this study

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.

Conditions

  • Anesthesia, Obstetrical
  • Analgesia, Epidural

Interventions

DRUG

PIEB: Patient Intermittent Epidural Boluses

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).

DRUG

PCEA: Patient Controlled Epidural Analgesia

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).

Sponsors & Collaborators

  • Hospital del Rio Hortega

    lead OTHER

Principal Investigators

  • M BELEN RODRIGUEZ-CAMPOO · Resident

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133091 on ClinicalTrials.gov