Evaluate Efficacy Levobupivacaine 0.125% Versuss Ropivacaine 0.2% in Hemodynamic Alterations in Labor and Fetal Repercussions

NCT05877131 | Unknown Phase 4

• 1 other identifier: CEI-pendiente
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: Most studies on analgesia in pregnant women in labor mainly evaluate the effect of anesthetics on pain, mentioning hypotension as a side effect without investigating its impact on fetal well-being. The objective of the present study is to evaluate the efficacy of the use of low doses of local anesthetic (LA) to prevent hemodynamic alterations that manifest as a loss of fetal well-being. METHODOLOGY/DESIGN: It is a randomized clinical trial. Patients will be pregnant women in labor (dilation period) who want epidural anesthesia (EA), who will randomly receive 0.125% levobupivacaine (Group L) versus 0.2% ropivacaine (Group R). In both groups, controls of hemodynamic parameters and their relationship with changes in fetal heart rate (FHR) and cardiotocographic recording (RCTG) will be carried out during the first 60 minutes after the administration of the local anesthetic via the epidural route. In case of hypotension and/or subsequent FHR and RCTG alterations, they will also be recorded. The follow-up period will extend from the moment the patient enters the delivery room and requests epidural anesthesia until the moment the patient is discharged from the delivery room. The percentage of patients with hemodynamic alterations will be evaluated as a primary result, as well as the percentage of patients whose hemodynamic alterations are related to changes in FHR and RCTG, when using low doses of LA. In the following will also be evaluated in relation to analgesia, the onset time, level reached and degree of satisfaction; and various intra and postpartum side effects. DISCUSSION: Both groups of pregnant women in labor will be studied in order to obtain data on the potential impact of the use of low doses of local anesthetic via the epidural route on hemodynamic parameters and the state of well-being of the fetus.

Conditions

Hemodynamic Instability; Epidural; Pregnancy; Fetal Cardiac Disorder

Keywords

Hemodynamic instability; Epidural; Pregnancy; Fetal Cardiac disorder

Outcome Measures

Primary Outcomes (7)

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  10 minutes before epidural

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  5 minutes after epidural

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  10 minutes after epidural

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  15 minutes after epidural

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  30 minutes after epidural

• Systemic vascular resistance ( units of measure:dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  45 minutes after epidural

• Systemic vascular resistance ( units of measure :dyn*s/cm5)

  Systemic vascular resistance (SVR) is expressed by the equation: SVR = (MAP - CVP)/CO, where MAP is mean arterial pressure and CVP is central venous pressure.

  60 minutes after epidural

Secondary Outcomes (105)

• Systolic Blood Pressure (units of measure :mmHg)

  10 minutes before epidural

• Systolic Blood Pressure (units of measure :mmHg)

  5 minutes after epidural

• Systolic Blood Pressure (units of measure :mmHg)

  10 minutes after epidural

• Systolic Blood Pressure (units of measure :mmHg)

  15 minutes after epidural

• Systolic Blood Pressure (units of measure :mmHg)

  30 minutes after epidural

Study Arms (2)

Levobupivacaina

ACTIVE COMPARATOR

Levobupivacaine 0.125% , dosage 10 ml frequency 1 one dosis duration 1 hour

Drug: Levobupivacaine

Ropivacaina

ACTIVE COMPARATOR

Ropivacaine 2 % , dosage 10 ml frequency 1 one dosis duration 1 hour

Drug: Ropivacaine

Interventions

Levobupivacaine DRUG

To evaluate the efficacy of low-dose levobupivacaine (0.125%) (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.

Levobupivacaina

Ropivacaine DRUG

To evaluate the efficacy of low-dose ropivacaine (0.2) in avoiding hemodynamic changes after performing regional analgesia in pregnant women in labor and preventing changes in fetal heart rate and cardiotocographic recording.

Ropivacaina

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Woman \> 18 years
• Request epidural anesthesia (EA)
• Expansion period
• Low obstetric risk
• ASA I-II (only one associated comorbidity, example: arterial hypertension, etc.)
• Cervix dilation ≥ 3
• single fetus
• Gestational age \> 36 weeks
• Normal Fetal Heart Rate (110 -160 beats / minute)
• Normal Cardiotocographic record or absence of fetal heart rate patterns suggestive of risk of loss of fetal well-being or non-reassuring cardiotocographic record.

You may not qualify if:

• VAS ≤ 2
• Breech presentation
• Maternal fever \> 38 years
• Pre-eclampsia and severe eclampsia
• Prenatal bleeding
• ASA II (more than one comorbidity)
• Chronic pain
• Substance abuse
• Contraindications for epidural analgesia (EA)
• Allergy to local anesthetics
• BMI \>40 kg/m²
• Presence of RCTG not reassuring

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Althaia Xarxa Assitensial i Universitaria Manresa

Manresa, Barcelona, 08243, Spain

Location

Related Publications (9)

• ACOG Committee on Practice Bulletins. ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 44, July 2003. (Replaces Committee Opinion Number 252, March 2001). Obstet Gynecol. 2003 Jul;102(1):203-13. No abstract available.

  PMID: 12850637 BACKGROUND

• Preston R, Crosby ET, Kotarba D, Dudas H, Elliott RD. Maternal positioning affects fetal heart rate changes after epidural analgesia for labour. Can J Anaesth. 1993 Dec;40(12):1136-41. doi: 10.1007/BF03009602.

  PMID: 8281589 BACKGROUND

• Lappen JR, Chien EK, Mercer BM. Contraction-Associated Maternal Heart Rate Decelerations: A Pragmatic Marker of Intrapartum Volume Status. Obstet Gynecol. 2018 Oct;132(4):1011-1017. doi: 10.1097/AOG.0000000000002808.

  PMID: 30130346 BACKGROUND

• Valensise H, Lo Presti D, Tiralongo GM, Pisani I, Gagliardi G, Vasapollo B, Frigo MG. Foetal heart rate deceleration with combined spinal-epidural analgesia during labour: a maternal haemodynamic cardiac study. J Matern Fetal Neonatal Med. 2016;29(12):1980-6. doi: 10.3109/14767058.2015.1072156. Epub 2015 Aug 28.

  PMID: 26333691 BACKGROUND

• Collins KM, Bevan DR, Beard RW. Fluid loading to reduce abnormalities of fetal heart rate and maternal hypotension during epidural analgesia in labour. Br Med J. 1978 Nov 25;2(6150):1460-1. doi: 10.1136/bmj.2.6150.1460.

  PMID: 719463 BACKGROUND

• Umstad MP, Ross A, Rushford DD, Permezel M. Epidural analgesia and fetal heart rate abnormalities. Aust N Z J Obstet Gynaecol. 1993 Aug;33(3):269-72. doi: 10.1111/j.1479-828x.1993.tb02083.x.

  PMID: 8304890 BACKGROUND

• Kubli M, Shennan AH, Seed PT, O'Sullivan G. A randomised controlled trial of fluid pre-loading before low dose epidural analgesia for labour. Int J Obstet Anesth. 2003 Oct;12(4):256-60. doi: 10.1016/S0959-289X(03)00071-2.

  PMID: 15321453 BACKGROUND

• Hofmeyr G, Cyna A, Middleton P. Prophylactic intravenous preloading for regional analgesia in labour. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD000175. doi: 10.1002/14651858.CD000175.pub2.

  PMID: 15494990 BACKGROUND

• Peyronnet V, Roses A, Girault A, Bonnet MP, Goffinet F, Tsatsaris V, Lecarpentier E. Lower limbs venous compression reduces the incidence of maternal hypotension following epidural analgesia during term labor. Eur J Obstet Gynecol Reprod Biol. 2017 Dec;219:94-99. doi: 10.1016/j.ejogrb.2017.10.016. Epub 2017 Oct 16.

  PMID: 29073508 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mauricio Roberto Argañaraz Quinteros, Physician

CONTACT

0034600609107; mraq1969@gmail.com

Susana Gonzalez Suarez

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: May 26, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)