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Completed

NCT Number: NCT02666794

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Andrade Santos

São Paulo, 05408000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural bupivacaine with vasoconstrictor 0.125%

Drug

10 ml

Epidural sufentanil

Drug

20 mcg

Placement of the epidural catheter

Procedure

Placement of the epidural catheter

Intrathecal hyperbaric bupivacaine solution 0.5%

Drug

2.5 mg

Intrathecal morphine

Drug

60 mcg

Placement of an epidural catheter to the catheter through technical needle

Procedure

Placement of an epidural catheter to the catheter through technical needle

Intrathecal sufentanil

Drug

5 mcg

Primary outcomes

  1. Cathecolamines levels

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

    Pattern of cathecolamines levels

  2. Fetal bradycardia

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

    Fetal bradycardia is defined as the baseline drops to less than 100 bpm

  3. Increase in uterine tone

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

    Increase in uterine tone (qualitative measure)

Secondary outcomes

  1. Maternal hipotension

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

Other outcomes

  1. Pain scores

    Time frame: 20 minutes after analgesia (measures every 5 minutes)

  2. APGAR score

    Time frame: At birth

  3. Fetal acidosis

    Time frame: At birth

    umbilical arterial blood

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2016
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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