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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2026-01-10

Brief Summary

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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

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Detailed Description

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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

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Cesarean Section Local Anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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chloroprocaine group

intrathecal fixed dose of chloroprocaine 1%

Group Type ACTIVE_COMPARATOR

Chloroprocaine 1% Injectable Solution

Intervention Type DRUG

• in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally

ropivacaine group

intrathecal fixed dose of ropivacaine 0.75%

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.75% Injectable Solution

Intervention Type DRUG

• in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally

Interventions

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Chloroprocaine 1% Injectable Solution

• in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally

Intervention Type DRUG

Ropivacaine 0.75% Injectable Solution

• in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No