Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Anesthesia, Obstetrical
- Sponsor
- Hospital del Río Hortega
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- VAS
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
MARIA BELEN RODRIGUEZ-CAMPOO
PhD title in Medicine and Surgery
Hospital del Río Hortega
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Bromage Scale(15 minutes after Epidural Block and 1 hour after epidural block)
- Labour Outcome(Delivery)
- Apgar at birth(5 minutes after birth)
- fetal pH at birth(0 minutes after delivery)
- Satisfaction (Likert Scale)(1 hour after delivery)
- Expulsive time(From 10 cm of dilatation until delivery)
- Total Dosis of Levobupivacaine(0 minutes after delivery)