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

NCT02666794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-03-08

No results posted yet for this study

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).

Conditions

  • Fetal Bradycardia
  • Hypertonic Uterine
  • Catecholamines

Interventions

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

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Shirley Santos, MD · Anesthesiologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2020-10-16
Completion
2020-10-16

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666794 on ClinicalTrials.gov