NCT06376058

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aretaieion University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cesarean Section
• Local Anesthetic

Interventions

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

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-01-10
• Completion: 2026-01-10
• First posted: 2024-04-19
• Last updated: 2025-07-22

Locations

1 site across 1 country: Greece