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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa
• Treatments: Levobupivacaine; Ropivacaine

Criteria

Inclusion Criteria:

• - 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.

Exclusion Criteria:

• 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