Shirley Andrade Santos
São Paulo, 05408000, Brazil
NCT Number: NCT02666794
Combined spinal-epidural (CSE) for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, possibly due to asymmetric decrease in catecholamine levels, when compared with epidural analgesia (EP).
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Notify Me18 year and older
Female
Interventional
Not applicable
São Paulo, 05408000, Brazil
Background: Combined spinal-epidural technique for labor analgesia has been associated with fetal bradycardia and uterine hypertonia, when compared with epidural analgesia, possibly due to asymmetric decrease in catecholamine levels (epinephrine and norepinephrine) following neuraxial block. However, there are no studies comparing plasmatic catecholamine levels between those two techniques. This study aimed to compare spinal-epidural versus epidural regarding pre and post-analgesia catecholamine levels, uterine tone and fetal heart rate.
Methods: Randomized clinical trial with 47 laboring patients divided in two groups. Primary outcome was plasmatic catecholamine measurements before and after neuraxial block. Secondary outcomes were fetal heart rate changes, uterine hypertonia, hypotension episodes, pain relief and fetal outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Parturients aged over 18 years were included when they requested labor analgesia. The inclusion criteria were: patients between 37 and 42 gestational weeks, single pregnancy, in active labor (induced or spontaneous), requesting analgesia with 7 cm or less of cervical dilation. As it is a center that attends only high-risk pregnancies, ASA II or III
Exclusion criteria
Contraindications to interventions, either due to severe comorbidity or contraindication to neuraxial block; previous use of systemic opioids during labor, maternal amniotic infection or known fetal diseases
10 ml
20 mcg
Placement of the epidural catheter
2.5 mg
60 mcg
Placement of an epidural catheter to the catheter through technical needle
5 mcg
Time frame: at the moment of analgesia and 20 minutes after
Pattern of cathecolamines levels
Time frame: 15 minutes before analgesia and 30 minutes after continuously
Fetal bradycardia is defined as the baseline drops to less than 100 bpm
Time frame: 15 minutes before analgesia and 30 minutes after continuously
Increase in uterine tone (qualitative measure)
Time frame: 30 minutes after analgesia (measures every 5 minutes)
Time frame: 20 minutes after analgesia (measures every 5 minutes)
Time frame: At birth
Time frame: At birth
umbilical arterial blood
University of Sao Paulo General Hospital
Other
Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
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