Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section (annie-mariana)

Aretaieion University Hospital

Status: Enrolling

Conditions: Cesarean Section; Local Anesthetic

Treatments: Drug: Ropivacaine 0.75% Injectable Solution; Drug: Chloroprocaine 1% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06376058

434/06-06-2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

chloroprocaine group

Active Comparator group

Description:

intrathecal fixed dose of chloroprocaine 1%

Treatment:

Drug: Chloroprocaine 1% Injectable Solution

ropivacaine group

Active Comparator group

Description:

intrathecal fixed dose of ropivacaine 0.75%

Treatment:

Drug: Ropivacaine 0.75% Injectable Solution