Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural

University of Sao Paulo General Hospital50 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Fetal Bradycardia Hypertonic Uterine Catecholamines

Interventions

Epidural bupivacaine with vasoconstrictor 0.125%DRUG

10 ml

Epidural sufentanilDRUG

20 mcg

Placement of the epidural catheterPROCEDURE

Placement of the epidural catheter

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shirley Andrade Santos

São Paulo, Brazil

Outcomes

Primary Outcomes

Cathecolamines levels

Pattern of cathecolamines levels

Time frame: at the moment of analgesia and 20 minutes after

Fetal bradycardia

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

Increase in uterine tone (qualitative measure)

Time frame: 15 minutes before analgesia and 30 minutes after continuously

Secondary Outcomes

Maternal hipotension

Time frame: 30 minutes after analgesia (measures every 5 minutes)

Data from ClinicalTrials.gov

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