Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section

Официальное название

Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study

Обзор

This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections

Подробное описание

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided. Combined spinal-epidural anesthesia has become the favorable technique for both elective and emergency cesarean sections. Various local anesthetics have been used, but ropivacaine is the drug of choice in most hospitals in Greece. However, chloroprocaine is a preferable local anesthetic in USA due to its quick and predictable onset of action. Chloroprocaine was initially used in 1980, but it became obsolete in those years due to neurological symptoms associated with its use caused mainly by the presence of sodium bisulfite and disodium ethylenediaminetetraacetate (EDTA) in the early formulations. Nowadays, new formulations of the drug without EDTA makes chloroprocaine safe for use.

The aim of the current randomized controlled trial will be to compare the effect of an intrathecal fixed dose of chloroprocaine versus an intrathecal fixed dose of ropivacaine in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia.

Вмешательства

• Препарат Chloroprocaine 1% Injectable Solution
  • in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally
• Препарат Ropivacaine 0.75% Injectable Solution
  • in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally

Первичные конечные точки

• Time from spinal anesthesia to T10 block (min) [Срок оценки: intraoperative]
• Time from spinal anesthesia to T4 block (min) [Срок оценки: intraoperative]
• Time of spinal anesthesia to Bromage =3 [Срок оценки: intraoperative]
• level of sensory block every 3 min [Срок оценки: intraoperative]
• level of sensory block every 15 min [Срок оценки: intraoperative]
• highest level of sensory block [Срок оценки: intraoperative]
• time from spinal anesthesia to highest level of sensory block [Срок оценки: intraoperative]
• duration of sensory block [Срок оценки: intraoperative]
• pain at surgical incision [Срок оценки: intraoperative]
• pain at neonatal delivery [Срок оценки: intraoperative]

Вторичные конечные точки (12)

• Neonatal Apgar score at 1 minute [Срок оценки: 1 minute post delivery]
• Neonatal Apgar score at 5 minutes [Срок оценки: 1 minute post delivery]
• neonatal blood gases [Срок оценки: 1 minute post delivery]
• incidence of neonatal acidosis [Срок оценки: 1 minute post delivery]
• incidence of hypotension [Срок оценки: intraoperative]
• incidence of bradycardia [Срок оценки: intraoperative]
• need for vasoconstrictor [Срок оценки: intraoperative]
• need for atropine [Срок оценки: intraoperative]
• incidence of nausea/vomiting [Срок оценки: intraoperative]
• incidence of dizziness [Срок оценки: intraoperative]
• incidence of drowsiness [Срок оценки: intraoperative]
• incidence of discomfort [Срок оценки: intraoperative]

Критерии участия

Критерии включения

• adult parturients, American Society of Anesthesiologists (ASA) I-II,
• singleton gestation>37 weeks
• elective cesarean section

Критерии исключения

• American Society of Anesthesiologists (ASA) > III
• age < 18 years
• singleton gestation <37 weeks
• Body Mass Index (BMI) >40 kg/m2
• Body weight <50 kg
• Body weight>100 kg
• height<150 cm
• height>180 cm
• multiple gestation
• emergency delivery
• fetal abnormality
• fetal distress
• pregnancy-induced pathology such as preeclampsia, eclampsia, premature labor, placental abnormalities
• pregnancy- induced diseases such as hepatic failure, pseudocholinesterase deficiency, neuromuscular diseases
• lack of informed consent
• contraindication for regional anesthesia such as thrombocytopenia, coagulation abnormalities, allergy to local anesthetics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• Aretaieion University Hospital — Athens

Публикации

• Maes S, Laubach M, Poelaert J. Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section. Acta Anaesthesiol Scand. 2016 May;60(5):642-9. doi: 10.1111/aas.12665. Epub 2015 Nov 26. PMID 26608876
• Saporito A, Ceppi M, Perren A, La Regina D, Cafarotti S, Borgeat A, Aguirre J, Van De Velde M, Teunkens A. Does spinal chloroprocaine pharmacokinetic profile actually translate into a clinical advantage in terms of clinical outcomes when compared to low-dose spinal bupivacaine? A systematic review and meta-analysis. J Clin Anesth. 2019 Feb;52:99-104. doi: 10.1016/j.jclinane.2018.09.003. Epub 2018 PMID 30237085
• Singariya G, Choudhary K, Kamal M, Bihani P, Pahuja H, Saini P. Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study. Indian J Anaesth. 2021 Feb;65(2):102-107. doi: 10.4103/ija.IJA_816_20. Epub 2021 Feb 10. PMID 33776083
• Baribeault T, Suss S. Spinal Anesthesia with 2-Chloroprocaine and Dexmedetomidine for Cesarean Section: A Case Report. AANA J. 2023 Jun;91(3):194-196. PMID 37227957

Идентификаторы

NCT: NCT06376058 · 434/06-06-2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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