Clinical trial NCT02666794: Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Official title: Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Bradycardia
Hypertonic Uterine
Catecholamines
Keywords: analgesia
fetal bradycardia
hypertonic uterine
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cathecolamines levels
timeFrame: at the moment of analgesia and 20 minutes after
measure: Fetal bradycardia
timeFrame: 15 minutes before analgesia and 30 minutes after continuously
measure: Increase in uterine tone
timeFrame: 15 minutes before analgesia and 30 minutes after continuously
Secondary outcomes:
measure: Maternal hipotension
timeFrame: 30 minutes after analgesia (measures every 5 minutes)
Other outcomes:
measure: Pain scores
timeFrame: 20 minutes after analgesia (measures every 5 minutes)
measure: APGAR score
timeFrame: At birth
measure: Fetal acidosis
timeFrame: At birth
Locations:
city: São Paulo
country: Brazil
facility: Shirley Andrade Santos
Study officials:
affiliation: Anesthesiologist
name: Shirley Santos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.
citation: Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.