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

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

Recruiting
18-48 years
Female
Phase N/A

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Overview

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

Description

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study details
    Cesarean Section
    Local Anesthetic

NCT06376058

Aretaieion University Hospital

1 August 2025

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