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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Local Anesthetic
• Intervention / Treatment: Drug: Chloroprocaine 1% Injectable Solution; Drug: Ropivacaine 0.75% Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kassiani Theodoraki, PhD, DESA; Phone Number: 6974634162; Email: ktheodoraki@hotmail.com
• Study Contact Backup: Name: Marianna Mavromati, MD; Email: marimavr14@gmail.com

Study Locations

• Greece
  • Athens, Greece, 11528
    • Recruiting
    • ARETAIEION University Hospital
    • Contact: Kassiani Theodoraki, PhD, DESA; Phone Number: 6974634162; Email: ktheodoraki@hotmail.com
    • Contact: Marianna Mavromati, MD; Email: marimavr14@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: chloroprocaine group; intrathecal fixed dose of chloroprocaine 1%	Drug: Chloroprocaine 1% Injectable Solution; • in parturients allocated to the chloroprocaine group, a fixed dose of chloroprocaine 1% will be administered intrathecally
Active Comparator: ropivacaine group; intrathecal fixed dose of ropivacaine 0.75%	Drug: Ropivacaine 0.75% Injectable Solution; • in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from spinal anesthesia to T10 block (min)	time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome	intraoperative
Time from spinal anesthesia to T4 block (min)	time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome	intraoperative
Time of spinal anesthesia to Bromage =3	time required from spinal anesthetic injection to complete motor block (Bromage scale=3, where Bromage=0, no block; Bromage=1, partial block; Bromage=2, almost complete block; Bromage=3, complete block	intraoperative
level of sensory block every 3 min	measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes	intraoperative
level of sensory block every 15 min	measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery	intraoperative
highest level of sensory block	measurement of the highest level of sensory block after intrathecal infusion of local anesthetic	intraoperative
time from spinal anesthesia to highest level of sensory block	time from the performance of spinal anesthesia to the highest level of sensory block	intraoperative
duration of sensory block	measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2	intraoperative
pain at surgical incision	pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable	intraoperative
pain at neonatal delivery	pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable	intraoperative
pain at peritoneal manipulation	pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable	intraoperative
pain at Post Anesthesia Care Unit (PACU) admission	pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable	1 hour postoperatively
pain at Post Anesthesia Care Unit (PACU) discharge	pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable	1 hour postoperatively
need for rescue analgesia intraoperatively	need for rescue analgesia during the operation, via epidural catheter or intravenously	intraoperative
Bromage scale every 3 min after spinal anesthesia	measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes	intraoperative
Bromage scale every 15 min	measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery	intraoperative
duration of motor block	measurement of time required for bromage scale to regress from 3 to 0	1 hour postoperatively
duration of staying in PACU	duration of parturient stay in PACU	2 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded	intraoperative
need for vasoconstrictor	any need for vasoconstrictor during the operation will be recorded	intraoperative
incidence of bradycardia	any incidence of maternal bradycardia (heart rate<60/min) will be recorded	intraoperative
need for atropine	any need for atropine during the operation because of bradycardia will be recorded	intraoperative
incidence of nausea/vomiting	any occurence of nausea and/or vomiting during the operation will be recorded	intraoperative
neonatal blood gases	fetal cord blood analysis will be performed immediately post-delivery	1 minute post delivery
Neonatal Apgar score at 1 minute	Neonatal Apgar score will be recorded at 1 minute after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts	1 minute post delivery
Neonatal Apgar score at 5 minutes	Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts	1 minute post delivery
incidence of neonatal acidosis	incidence of neonatal acidosis (PH<7.2) will be recorded	1 minute post delivery
incidence of dizziness	any occurence of dizziness during the operation will be recorded	intraoperative
incidence of drowsiness	any occurence of drowsiness during the operation will be recorded	intraoperative
incidence of discomfort	any occurence of discomfort during the operation will be recorded	intraoperative
incidence of shivering	any occurence of shivering during the operation will be recorded	intraoperative
need for rescue analgesia in PACU	need for rescue analgesia in PACU when VAS scale >4 will be recorded	2 hours postoperatively
time from spinal anesthesia to rescue analgesia in PACU	time from spinal anesthesia to rescue analgesia in PACU will be recorded	2 hours postoperatively
incidence of neurological symptoms during hospital stay	incidence of neurological symptoms during hospitalization will be recorded	5 days postoperatively
incidence of neurological symptoms 2 months after the operation	incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication	2 months after discharge
incidence of low back pain	incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication	2 months after discharge
time from spinal anesthesia to mobilization	time from spinal anesthesia to mobilization of parturient will be recorded	2 days postoperatively
mother's satisfaction from anesthesia	mother's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction	1 day postoperatively
gynecologist's satisfaction	gynecologist's satisfaction from anesthesia will be recorded using Likert scale. Likert scale ranges from 1 which is the minimum satisfaction to 4 which is the maximum satisfaction	1 hour postoperatively

Collaborators and Investigators

• Sponsor: Aretaieion University Hospital
• Investigators: Principal Investigator: Kassiani Theodoraki, PhD, DESA, ARETAIEION University Hospital

Publications and helpful links

General Publications

• 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.
• 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 Sep 18.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): January 10, 2026
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Pharmaceutical Solutions; Chloroprocaine
• Other Study ID Numbers: 434/06-06-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No