NCT02666794

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

Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• Fetal Bradycardia
• Hypertonic Uterine
• Catecholamines

Interventions

Type	Name	Description
DRUG	Epidural bupivacaine with vasoconstrictor 0.125%	10 ml
DRUG	Epidural sufentanil	20 mcg
PROCEDURE	Placement of the epidural catheter	Placement of the epidural catheter
DRUG	Intrathecal hyperbaric bupivacaine solution 0.5%	2.5 mg
DRUG	Intrathecal morphine	60 mcg
PROCEDURE	Placement of an epidural catheter to the catheter through technical needle	Placement of an epidural catheter to the catheter through technical needle
DRUG	Intrathecal sufentanil	5 mcg

Timeline

• Start date: 2017-07-12
• Primary completion: 2020-10-16
• Completion: 2020-10-16
• First posted: 2016-01-28
• Last updated: 2022-03-08

Locations

1 site across 1 country: Brazil