Labor Epidural Analgesia Clinical Trial
Official title:
Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia
The investigators have design an observational study to know the anesthetic consumption in
terms of rescue analgesia (Patient Controlled Epidural Analgesia (PCEA) and manual boluses)
of the combination of different modes of administration of local anesthetic in the epidural
space during labor analgesia offered by the new version of the CADD® infusion pump.
Also in this pump the anesthetic can be administered across a system of standard flow
(40-250ml/h) or of high flow (40-500ml/h), what according to studies can influence the
diffusion epidural of the anesthetic and therefore the level of sensitive blockade.
The study is designed with healthy patients, first-time mothers, in childbearing dynamics,
term pregnancy and nullipary. The epidural technique was performed with dose test of 3ml of
bupivacaína 0,25 % with vasoconstrictor and a manual bolus of 0,1ml/Kg of ropivacaína 0,2%
with fentanilo 5ug/ml.
As soon as the informed consent about the epidural anesthesia was signed, the patient was
informed of the possibility of taking part in the study and there is offered him the sheet of
information of the patient. So in one group they were administered Programed Intermittent
Epidural Boluses (PIEB) and in other group continuous Epidural Infusion (IC) plus PIEB
according to the usual clinical practice of each anesthesiologist. In both cases the
perfusion was of ropivacaína 0,1 % more fentanilo 2ug/ml, so that in the first group it was
administered PIEB of 10ml every hour and in the second group a continuous infusion to 3ml/h
plus PIEB of 7ml every hour. Also if during the period of dilatation an AVE (Analogical
Visual Escale) greater than or equal to 4 appeared (inadequate analgesia) the patient could
administer a 5ml PCEA bolus of the same solution (interval of closing of 20min and maximum
dose for hour of 15ml), as it is done in according to the usual clinical practice. And if
after two boluses of PCEA the analgesia was still ineffective a clinical bolus of 4ml of
lidocaína to 1 % was administered by the anesthesiologist.
In addition, in the group that was administered only PIEB, the standard infusion system was
compared with the high-flow infusion system.
In all patients it was evaluated and noted on the epidural record sheet the intensity of the
pain as the analogical visual scale (AVE), the grade of motor blockade as the modified scale
of Bromage and the sensitive level in different periods of time. Also registered the total
doses of anesthetic, the way of the childbearing finishes, the Apgar of the newborn, the
grade of maternal satisfaction and the side effects. Also through the software of the pump it
was verified if the patient had been administered rescue analgesia (PCEA or clinical
boluses).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT06403982 -
The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia
|
N/A | |
| Completed |
NCT02768272 -
PIEB vs PCEA With Epidural or CSE Technique. A Randomized Double Blind Clinical Trial
|
Phase 4 |