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

Not Applicable

Completed

• Conditions: Fetal Bradycardia; Hypertonic Uterine; Catecholamines
• Interventions: Drug: Epidural bupivacaine with vasoconstrictor 0.125%; Drug: Intrathecal hyperbaric bupivacaine solution 0.5%; Drug: Epidural sufentanil; Drug: Intrathecal morphine; Procedure: Placement of the epidural catheter; Procedure: Placement of an epidural catheter to the catheter through technical needle; Drug: Intrathecal sufentanil

• Registration Number: NCT02666794
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2016-01-24
• Study First Posted: 2016-01-28
• Study Start: 2017-07-12
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Puncture epidural	Epidural bupivacaine with vasoconstrictor 0.125%	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
Puncture epidural	Placement of the epidural catheter	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
Puncture combined spinal-epidural	Intrathecal hyperbaric bupivacaine solution 0.5%	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
Puncture combined spinal-epidural	Placement of an epidural catheter to the catheter through technical needle	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
Puncture combined spinal-epidural	Intrathecal sufentanil	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
Puncture epidural	Epidural sufentanil	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
Puncture combined spinal-epidural	Intrathecal morphine	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

Primary Outcome Measures

Name	Time	Method
Cathecolamines levels	at the moment of analgesia and 20 minutes after	Pattern of cathecolamines levels
Fetal bradycardia	15 minutes before analgesia and 30 minutes after continuously	Fetal bradycardia is defined as the baseline drops to less than 100 bpm
Increase in uterine tone	15 minutes before analgesia and 30 minutes after continuously	Increase in uterine tone (qualitative measure)

Secondary Outcome Measures

Name	Time	Method
Maternal hipotension	30 minutes after analgesia (measures every 5 minutes)

Trial Locations

Locations (1)

Shirley Andrade Santos; 🇧🇷 São Paulo, Brazil