search
Back to results

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

Primary Purpose

Fetal Bradycardia, Hypertonic Uterine, Catecholamines

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Epidural bupivacaine with vasoconstrictor 0.125%
Epidural sufentanil
Placement of the epidural catheter
Intrathecal hyperbaric bupivacaine solution 0.5%
Intrathecal morphine
Placement of an epidural catheter to the catheter through technical needle
Intrathecal sufentanil
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Bradycardia focused on measuring analgesia, fetal bradycardia, hypertonic uterine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Shirley Andrade Santos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Puncture epidural

Puncture combined spinal-epidural

Arm 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

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

Outcomes

Primary Outcome Measures

Cathecolamines levels
Pattern of cathecolamines levels
Fetal bradycardia
Fetal bradycardia is defined as the baseline drops to less than 100 bpm
Increase in uterine tone
Increase in uterine tone (qualitative measure)

Secondary Outcome Measures

Maternal hipotension

Full Information

First Posted
December 21, 2015
Last Updated
March 4, 2022
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02666794
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Bradycardia, Hypertonic Uterine, Catecholamines
Keywords
analgesia, fetal bradycardia, hypertonic uterine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Puncture epidural
Arm Type
Active Comparator
Arm 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
Arm Title
Puncture combined spinal-epidural
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Epidural bupivacaine with vasoconstrictor 0.125%
Intervention Description
10 ml
Intervention Type
Drug
Intervention Name(s)
Epidural sufentanil
Intervention Description
20 mcg
Intervention Type
Procedure
Intervention Name(s)
Placement of the epidural catheter
Intervention Description
Placement of the epidural catheter
Intervention Type
Drug
Intervention Name(s)
Intrathecal hyperbaric bupivacaine solution 0.5%
Intervention Description
2.5 mg
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine
Intervention Description
60 mcg
Intervention Type
Procedure
Intervention Name(s)
Placement of an epidural catheter to the catheter through technical needle
Intervention Description
Placement of an epidural catheter to the catheter through technical needle
Intervention Type
Drug
Intervention Name(s)
Intrathecal sufentanil
Intervention Description
5 mcg
Primary Outcome Measure Information:
Title
Cathecolamines levels
Description
Pattern of cathecolamines levels
Time Frame
at the moment of analgesia and 20 minutes after
Title
Fetal bradycardia
Description
Fetal bradycardia is defined as the baseline drops to less than 100 bpm
Time Frame
15 minutes before analgesia and 30 minutes after continuously
Title
Increase in uterine tone
Description
Increase in uterine tone (qualitative measure)
Time Frame
15 minutes before analgesia and 30 minutes after continuously
Secondary Outcome Measure Information:
Title
Maternal hipotension
Time Frame
30 minutes after analgesia (measures every 5 minutes)
Other Pre-specified Outcome Measures:
Title
Pain scores
Time Frame
20 minutes after analgesia (measures every 5 minutes)
Title
APGAR score
Time Frame
At birth
Title
Fetal acidosis
Description
umbilical arterial blood
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Santos, MD
Organizational Affiliation
Anesthesiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Andrade Santos
City
São Paulo
ZIP/Postal Code
05408000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20205623
Citation
Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.
Results Reference
background
PubMed Identifier
19104358
Citation
Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.
Results Reference
result
PubMed Identifier
11359226
Citation
Van de Velde M, Vercauteren M, Vandermeersch E. Fetal heart rate abnormalities after regional analgesia for labor pain: the effect of intrathecal opioids. Reg Anesth Pain Med. 2001 May-Jun;26(3):257-62. doi: 10.1053/rapm.2001.22258.
Results Reference
result
PubMed Identifier
8831313
Citation
Nielsen PE, Erickson JR, Abouleish EI, Perriatt S, Sheppard C. Fetal heart rate changes after intrathecal sufentanil or epidural bupivacaine for labor analgesia: incidence and clinical significance. Anesth Analg. 1996 Oct;83(4):742-6. doi: 10.1097/00000539-199610000-00014.
Results Reference
result
PubMed Identifier
7760614
Citation
Collis RE, Davies DW, Aveling W. Randomised comparison of combined spinal-epidural and standard epidural analgesia in labour. Lancet. 1995 Jun 3;345(8962):1413-6. doi: 10.1016/s0140-6736(95)92602-x.
Results Reference
result
PubMed Identifier
19750306
Citation
Nakamura G, Ganem EM, Rugolo LM, Castiglia YM. Effects on mother and fetus of epidural and combined spinal-epidural techniques for labor analgesia. Rev Assoc Med Bras (1992). 2009 Jul-Aug;55(4):405-9. doi: 10.1590/s0104-42302009000400014.
Results Reference
result
PubMed Identifier
24738803
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.
Results Reference
result
PubMed Identifier
23076897
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs