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

Catecholamines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666794
• Other study ID #: 45992815000000068
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: October 16, 2020

Study information

• Verified date: March 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 16, 2020
• Est. primary completion date: October 16, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Catecholamines
• Fetal Bradycardia
• Hypertonic Uterine

Intervention

Drug:
• Epidural bupivacaine with vasoconstrictor 0.125%
10 ml
• Epidural sufentanil
20 mcg

Procedure:
• Placement of the epidural catheter
Placement of the epidural catheter

Drug:
• Intrathecal hyperbaric bupivacaine solution 0.5%
2.5 mg
• Intrathecal morphine
60 mcg

Procedure:
• Placement of an epidural catheter to the catheter through technical needle
Placement of an epidural catheter to the catheter through technical needle

Drug:
• Intrathecal sufentanil
5 mcg

Locations

Country	Name	City	State
Brazil	Shirley Andrade Santos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Abrão 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.0b013e31818f5eb — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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:CD003401. doi: 10.1002/14651858.CD003401.pub3. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain scores		20 minutes after analgesia (measures every 5 minutes)
Other	APGAR score		At birth
Other	Fetal acidosis	umbilical arterial blood	At birth
Primary	Cathecolamines levels	Pattern of cathecolamines levels	at the moment of analgesia and 20 minutes after
Primary	Fetal bradycardia	Fetal bradycardia is defined as the baseline drops to less than 100 bpm	15 minutes before analgesia and 30 minutes after continuously
Primary	Increase in uterine tone	Increase in uterine tone (qualitative measure)	15 minutes before analgesia and 30 minutes after continuously
Secondary	Maternal hipotension		30 minutes after analgesia (measures every 5 minutes)