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Completed

NCT Number: NCT03133091

Epidural Analgesia During Labour

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.

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Key information

Conditions

Anesthesia, Obstetrical Agnosia Analgesia, Epidural Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PIEB: Patient Intermittent Epidural Boluses

Drug

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 Analgesia

Drug

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).

Primary outcomes

  1. VAS

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

    Change from baseline in Visual Analog Scale

Secondary outcomes

  1. Satisfaction (Likert Scale)

    Time frame: 1 hour after delivery

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

  2. Bromage Scale

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

  3. Labour Outcome

    Time frame: Delivery

    Eutocic

  4. Labour Outcome

    Time frame: Delivery

    instrumental

  5. Labour Outcome

    Time frame: Delivery

    cesarean section

  6. Expulsive time

    Time frame: From 10 cm of dilatation until delivery

  7. Apgar at birth

    Time frame: 1 minute after birth

    Apgar measured in 1 minute

  8. Apgar at birth

    Time frame: 5 minutes after birth

    Apgar measured in 5 minutes

  9. fetal pH at birth

    Time frame: 0 minutes after delivery

    0 minutes after delivery

  10. Total Dosis of Levobupivacaine

    Time frame: 0 minutes after delivery

    miligrams

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine

Acronym: PIEBvsPCEA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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