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

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Catecholamines
Fetal Bradycardia
Hypertonic Uterine

Treatments

Drug: Intrathecal morphine
Procedure: Placement of the epidural catheter
Procedure: Placement of an epidural catheter to the catheter through technical needle
Drug: Epidural sufentanil
Drug: Intrathecal sufentanil
Drug: Epidural bupivacaine with vasoconstrictor 0.125%
Drug: Intrathecal hyperbaric bupivacaine solution 0.5%

Study type

Interventional

Funder types

Other

Identifiers

NCT02666794
45992815000000068

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

Puncture epidural
Active Comparator group
Description:
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
Treatment:
Drug: Epidural bupivacaine with vasoconstrictor 0.125%
Drug: Epidural sufentanil
Procedure: Placement of the epidural catheter
Puncture combined spinal-epidural
Active Comparator group
Description:
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
Treatment:
Drug: Intrathecal hyperbaric bupivacaine solution 0.5%
Drug: Intrathecal sufentanil
Procedure: Placement of an epidural catheter to the catheter through technical needle
Drug: Intrathecal morphine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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