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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Bradycardia, Hypertonic Uterine, Catecholamines

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Puncture epidural<br>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 | Drug: Epidural bupivacaine with vasoconstrictor 0.125%<br>* 10 ml<br>Drug: Epidural sufentanil<br>* 20 mcg<br>Procedure: Placement of the epidural catheter<br>* Placement of the epidural catheter<br>|
| Active Comparator: Puncture combined spinal-epidural<br>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 | Drug: Intrathecal hyperbaric bupivacaine solution 0.5%<br>* 2.5 mg<br>Drug: Intrathecal morphine<br>* 60 mcg<br>Procedure: Placement of an epidural catheter to the catheter through technical needle<br>* Placement of an epidural catheter to the catheter through technical needle<br>Drug: Intrathecal sufentanil<br>* 5 mcg<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hipotension |  | 30 minutes after analgesia (measures every 5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, fetal bradycardia, hypertonic uterine