Analgesia, Epidural, Anesthesia, Obstetrical
Conditions
Keywords
PIEB, PCEA, LEVOBUPIVACAINE
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.
Interventions
DRUGPIEB: 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).
DRUGPCEA: 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
Hospital del Rio Hortega
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery | Change from baseline in Visual Analog Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bromage Scale | 15 minutes after Epidural Block and 1 hour after epidural block | — |
| Labour Outcome | Delivery | Eutocic |
| Expulsive time | From 10 cm of dilatation until delivery | — |
| Satisfaction (Likert Scale) | 1 hour after delivery | 1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all) |
| fetal pH at birth | 0 minutes after delivery | 0 minutes after delivery |
| Total Dosis of Levobupivacaine | 0 minutes after delivery | miligrams |
| Apgar at birth | 1 minute after birth | Apgar measured in 1 minute |
Countries
Spain
Outcome results
None listed