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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02666794

Enrollment

Registered

2016-01-28

Start date

2017-07-12

Completion date

2020-10-16

Last updated

2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catecholamines, Fetal Bradycardia, Hypertonic Uterine

Keywords

analgesia, fetal bradycardia, hypertonic uterine

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.

Interventions

DRUGEpidural bupivacaine with vasoconstrictor 0.125%

10 ml

DRUGEpidural sufentanil

20 mcg

PROCEDUREPlacement of the epidural catheter

Placement of the epidural catheter

DRUGIntrathecal hyperbaric bupivacaine solution 0.5%

2.5 mg

DRUGIntrathecal morphine

60 mcg

PROCEDUREPlacement of an epidural catheter to the catheter through technical needle

Placement of an epidural catheter to the catheter through technical needle

DRUGIntrathecal sufentanil

5 mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Maternal hipotension	30 minutes after analgesia (measures every 5 minutes)

Other

Measure	Time frame	Description
Pain scores	20 minutes after analgesia (measures every 5 minutes)	—
Fetal acidosis	At birth	umbilical arterial blood
APGAR score	At birth	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026