Epidural Analgesia During Labour (PIEBvsPCEA)

Hospital del Río Hortega

Status and phase: Completed; Phase 3

Conditions: Analgesia, Epidural; Anesthesia, Obstetrical

Treatments: Drug: PIEB: Patient Intermittent Epidural Boluses; Drug: PCEA: Patient Controlled Epidural Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03133091

290587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

PIEB (Patient Intermittent Epidural Bolus)

Active Comparator group

Description:

PIEB: The boluses are programmed every 30 minutes. The patient can ask for another extra bolus in between if she wishes. The dosis per hour are equivalent to the PCEA. We make a comparison between PCEA vs PIEB.

Treatment:

Drug: PIEB: Patient Intermittent Epidural Boluses

PCEA (Patient continuous Epidural Analgesia)

Active Comparator group

Description:

PCEA: There is a continuous infusion and the patient can order extra boluses every 15 minutes. The dosis per hour are equivalent to the other arm to the PIEB. We make a comparison between PCEA vs PIEB.

Treatment:

Drug: PCEA: Patient Controlled Epidural Analgesia