Impact of Labor Analgesia on Serum Catecholamine Levels, Fetal Heart Rate and Uterine Tone in Pregnancies With Comorbidities

Comparative Clinical Trial on the Impact of Labor Analgesia on Serum Catecholamine Levels, Fetal Heart Rate and Uterine Tone in Pregnancies With Comorbidities

Sponsors

Lead Sponsor: University of Sao Paulo General Hospital

Source University of Sao Paulo General Hospital
Brief Summary

The combined spinal-epidural analgesia during the labor has been associated with more changes in fetal heart rate and uterine tonus than epidural analgesia, and the opinions in literature are not fully consolidated. The decrease of cathecolamines levels are implicated in this changes, but there is not studies in patients with comorbidities or with modern labor analgesia.

Detailed Description

INTRODUCTION: The combined spinal-epidural analgesia during the labor has been associated with more changes in fetal heart rate and uterine tonus than epidural analgesia, and the opinions in literature are not fully consolidated. The decrease of cathecolamines levels are implicated in this changes, but there is not studies in patients with comorbidities or with modern labor analgesia. OBJECTIVES: To estimate the effects of combined spinal-epidural analgesia and epidural analgesia on maternal cathecolamines levels, fetal heart rate and uterine basal tone in pregnancies with comorbidities METHOD: This is experimental, analytical, prospective, randomized, double-blind. It will include 50 pregnant women with gestations with comorbidities, admitted on labor. Pregnants will be randomly divided into two groups: combined spinal-epidural analgesia and epidural analgesia. The primary dependent variables to be evaluated will be the change in cathecolamine levels, uterine tone and changes in the fetal heart rate.

Overall Status Completed
Start Date 2017-07-12
Completion Date 2020-10-16
Primary Completion Date 2020-10-16
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Cathecolamines levels at the moment of analgesia and 20 minutes after
Fetal bradycardia 15 minutes before analgesia and 30 minutes after continuously
Increase in uterine tone 15 minutes before analgesia and 30 minutes after continuously
Secondary Outcome
Measure Time Frame
Maternal hipotension 30 minutes after analgesia (measures every 5 minutes)
Enrollment 50
Condition
Intervention

Intervention Type: Drug

Intervention Name: Epidural bupivacaine with vasoconstrictor 0.125%

Description: 10 ml

Arm Group Label: Puncture epidural

Intervention Type: Drug

Intervention Name: Epidural sufentanil

Description: 20 mcg

Arm Group Label: Puncture epidural

Intervention Type: Procedure

Intervention Name: Placement of the epidural catheter

Description: Placement of the epidural catheter

Arm Group Label: Puncture epidural

Intervention Type: Drug

Intervention Name: Intrathecal hyperbaric bupivacaine solution 0.5%

Description: 2.5 mg

Arm Group Label: Puncture combined spinal-epidural

Intervention Type: Drug

Intervention Name: Intrathecal morphine

Description: 60 mcg

Arm Group Label: Puncture combined spinal-epidural

Intervention Type: Procedure

Intervention Name: Placement of an epidural catheter to the catheter through technical needle

Description: Placement of an epidural catheter to the catheter through technical needle

Arm Group Label: Puncture combined spinal-epidural

Intervention Type: Drug

Intervention Name: Intrathecal sufentanil

Description: 5 mcg

Arm Group Label: Puncture combined spinal-epidural

Eligibility

Criteria:

Inclusion Criteria: - previous diagnosis of intrauterine growth restriction - maternal diseases that attend with chronic placental insufficiency (obesity, diabetes, arterial hypertension, kidney disease, thrombophilias, heart disease or lung disease for example) Exclusion Criteria: - patients ASA I or IV - contraindications regional analgesia - prior use of systemic opioids for the relief of labor pain - amniotic, and maternal infection - known fetal diseases

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Shirley Santos, MD Principal Investigator Anesthesiologist
Location
Facility: Shirley Andrade Santos
Location Countries

Brazil

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Sao Paulo General Hospital

Investigator Full Name: SHIRLEY ANDRADE SANTOS

Investigator Title: Anesthesiologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Puncture epidural

Type: Active Comparator

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

Label: Puncture combined spinal-epidural

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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