Plasmatic Catecholamines: Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
Plasmatic Catecholamines After Neuraxial Labor Analgesia: a Randomized Controlled Trial Comparing Epidural Versus Combined Spinal-epidural
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedStudy Start
First participant enrolled
July 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2020
CompletedMarch 8, 2022
March 1, 2022
3.3 years
December 21, 2015
March 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Maternal hipotension
30 minutes after analgesia (measures every 5 minutes)
Other Outcomes (3)
Pain scores
20 minutes after analgesia (measures every 5 minutes)
APGAR score
At birth
Fetal acidosis
At birth
Study Arms (2)
Puncture epidural
ACTIVE COMPARATORWomen 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
Puncture combined spinal-epidural
ACTIVE COMPARATORThe 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
Interventions
Placement of an epidural catheter to the catheter through technical needle
Eligibility Criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Andrade Santos
São Paulo, 05408000, Brazil
Related Publications (8)
Baschat AA. Fetal growth restriction - from observation to intervention. J Perinat Med. 2010 May;38(3):239-46. doi: 10.1515/jpm.2010.041.
PMID: 20205623BACKGROUNDAbrao 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.
PMID: 19104358RESULTVan 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.
PMID: 11359226RESULTNielsen 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.
PMID: 8831313RESULTCollis 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.
PMID: 7760614RESULTNakamura 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.
PMID: 19750306RESULTPatel 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.
PMID: 24738803RESULTSimmons 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.
PMID: 23076897RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirley Santos, MD
Anesthesiologist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
December 21, 2015
First Posted
January 28, 2016
Study Start
July 12, 2017
Primary Completion
October 16, 2020
Study Completion
October 16, 2020
Last Updated
March 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share