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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Catecholamines; Fetal Bradycardia; Hypertonic Uterine

Treatments: Drug: Intrathecal hyperbaric bupivacaine solution 0.5%; Procedure: Placement of an epidural catheter to the catheter through technical needle; Drug: Epidural bupivacaine with vasoconstrictor 0.125%; Drug: Intrathecal sufentanil; Drug: Epidural sufentanil; Procedure: Placement of the epidural catheter; Drug: Intrathecal morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02666794

45992815000000068

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Puncture epidural

Active Comparator group

Description:

Women in labor the epidural group will receive epidural bupivacaine with vasoconstrictor 0.125% 10 ml plus 20 micrograms sufentanil, followed by the placement of the epidural catheter

Treatment:

Drug: Epidural bupivacaine with vasoconstrictor 0.125%

Procedure: Placement of the epidural catheter

Drug: Epidural sufentanil

Puncture combined spinal-epidural

Active Comparator group

Description:

The mothers of the combined spinal-epidural analgesia group will receive intrathecal hyperbaric bupivacaine solution 0.5% 2.5 mg plus 5.0 micrograms of sufentanil and plus 60 micrograms of morphine, followed by placement of an epidural catheter to the catheter through technical needle

Treatment:

Drug: Intrathecal sufentanil

Procedure: Placement of an epidural catheter to the catheter through technical needle

Drug: Intrathecal hyperbaric bupivacaine solution 0.5%

Drug: Intrathecal morphine