Epidural Analgesia During Labour

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia, Obstetrical, Analgesia, Epidural

Intervention / Treatment
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* Drug: PIEB: Patient Intermittent Epidural Boluses
* Drug: PCEA: Patient Controlled Epidural Analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PIEB (Patient Intermittent Epidural Bolus)<br>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. | Drug: PIEB: Patient Intermittent Epidural Boluses<br>* 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).<br>|
| Active Comparator: PCEA (Patient continuous Epidural Analgesia)<br>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. | Drug: PCEA: Patient Controlled Epidural Analgesia<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Change from baseline in Visual Analog Scale | 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PIEB, PCEA, LEVOBUPIVACAINE