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RecruitingNCT06376058annie-marianaUpdated Jul 22, 2025

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

An interventional study of Chloroprocaine 1% Injectable Solution and Ropivacaine 0.75% Injectable Solution in Cesarean Section and Local Anesthetic, sponsored by Aretaieion University Hospital. Recruiting at 1 site in Greece. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2025-07-22.

Sponsored by Aretaieion University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Jan 2024, registered Apr 2024).
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 48 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Cesarean Section
  • Local Anesthetic
03

In context

Lead sponsor

Aretaieion University Hospital is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 48 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    chloroprocaine group

    intrathecal fixed dose of chloroprocaine 1%

    Drug: Chloroprocaine 1% Injectable Solution

  • Active comparator
    ropivacaine group

    intrathecal fixed dose of ropivacaine 0.75%

    Drug: Ropivacaine 0.75% Injectable Solution

Interventions

  • DrugChloroprocaine 1% Injectable Solution

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

  • DrugRopivacaine 0.75% Injectable Solution

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

06

What researchers measure

Primary outcomes

  1. Time from spinal anesthesia to T10 block (min)

    time required from spinal anesthetic injection to anesthetic block up to the 10th thoracic neurotome

    Time frame: intraoperative

  2. Time from spinal anesthesia to T4 block (min)

    time required from spinal anesthetic injection to anesthetic block up to the 4th thoracic neurotome

    Time frame: intraoperative

  3. 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

    Time frame: intraoperative

  4. level of sensory block every 3 min

    measurement of sensory block every 3 minutes after spinal anesthesia during the first 15 minutes

    Time frame: intraoperative

  5. level of sensory block every 15 min

    measurement of sensory block every 15 minutes from spinal anesthesia to the end of the surgery

    Time frame: intraoperative

  6. highest level of sensory block

    measurement of the highest level of sensory block after intrathecal infusion of local anesthetic

    Time frame: intraoperative

  7. time from spinal anesthesia to highest level of sensory block

    time from the performance of spinal anesthesia to the highest level of sensory block

    Time frame: intraoperative

  8. duration of sensory block

    measurement of time required for the sensory block to regress from sensory level T4 to sensory level T12/L2

    Time frame: intraoperative

  9. pain at surgical incision

    pain at skin incision using Visual Analogue Scale (VAS), where VAS=0, no pain; VAS=10, worst pain imaginable

    Time frame: intraoperative

  10. pain at neonatal delivery

    pain at neonatal delivery using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable

    Time frame: intraoperative

  11. pain at peritoneal manipulation

    pain at peritoneal manipulation using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable

    Time frame: intraoperative

  12. 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

    Time frame: 1 hour postoperatively

  13. 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

    Time frame: 1 hour postoperatively

  14. need for rescue analgesia intraoperatively

    need for rescue analgesia during the operation, via epidural catheter or intravenously

    Time frame: intraoperative

  15. Bromage scale every 3 min after spinal anesthesia

    measurement of bromage scale every 3 minutes after spinal anesthesia during the first 15 minutes

    Time frame: intraoperative

  16. Bromage scale every 15 min

    measurement of bromage scale every 15 minutes from spinal anesthesia to the end of the surgery

    Time frame: intraoperative

  17. duration of motor block

    measurement of time required for bromage scale to regress from 3 to 0

    Time frame: 1 hour postoperatively

  18. duration of staying in PACU

    duration of parturient stay in PACU

    Time frame: 2 hours postoperatively

Secondary outcomes

  1. 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

    Time frame: 1 minute post delivery

  2. 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

    Time frame: 1 minute post delivery

  3. neonatal blood gases

    fetal cord blood analysis will be performed immediately post-delivery

    Time frame: 1 minute post delivery

  4. incidence of neonatal acidosis

    incidence of neonatal acidosis (PH\<7.2) will be recorded

    Time frame: 1 minute post delivery

  5. incidence of hypotension

    any occurence of hypotension (systolic blood pressure\<80% of baseline) throughout the operation will be recorded

    Time frame: intraoperative

  6. incidence of bradycardia

    any incidence of maternal bradycardia (heart rate\<60/min) will be recorded

    Time frame: intraoperative

  7. need for vasoconstrictor

    any need for vasoconstrictor during the operation will be recorded

    Time frame: intraoperative

  8. need for atropine

    any need for atropine during the operation because of bradycardia will be recorded

    Time frame: intraoperative

  9. incidence of nausea/vomiting

    any occurence of nausea and/or vomiting during the operation will be recorded

    Time frame: intraoperative

  10. incidence of dizziness

    any occurence of dizziness during the operation will be recorded

    Time frame: intraoperative

  11. incidence of drowsiness

    any occurence of drowsiness during the operation will be recorded

    Time frame: intraoperative

  12. incidence of discomfort

    any occurence of discomfort during the operation will be recorded

    Time frame: intraoperative

  13. incidence of shivering

    any occurence of shivering during the operation will be recorded

    Time frame: intraoperative

  14. need for rescue analgesia in PACU

    need for rescue analgesia in PACU when VAS scale \>4 will be recorded

    Time frame: 2 hours postoperatively

  15. time from spinal anesthesia to rescue analgesia in PACU

    time from spinal anesthesia to rescue analgesia in PACU will be recorded

    Time frame: 2 hours postoperatively

  16. incidence of neurological symptoms during hospital stay

    incidence of neurological symptoms during hospitalization will be recorded

    Time frame: 5 days postoperatively

  17. 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

    Time frame: 2 months after discharge

  18. incidence of low back pain

    incidence of low back pain 2 months after discharge from the hospital will be recorded by phone communication

    Time frame: 2 months after discharge

  19. time from spinal anesthesia to mobilization

    time from spinal anesthesia to mobilization of parturient will be recorded

    Time frame: 2 days postoperatively

  20. 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

    Time frame: 1 day postoperatively

  21. 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

    Time frame: 1 hour postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 26608876 ↗
  • 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. PubMed 30237085 ↗
  • 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. PubMed 33776083 ↗
  • 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. PubMed 37227957 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376058
Lead sponsor
Aretaieion University Hospital
Responsible party
Dr Kassiani Theodoraki (Professor of Anesthesiology, Aretaieion University Hospital) — Principal investigator
First posted
Apr 19, 2024
Start date
Jan 10, 2024
Primary completion
Jan 10, 2026 (estimated)
Completion
Jan 10, 2026 (estimated)
Last update
Jul 22, 2025

Study contacts

Kassiani Theodoraki, PhD, DESA
Contact
ktheodoraki@hotmail.com
6974634162
Marianna Mavromati, MD
Contact
marimavr14@gmail.com
Kassiani Theodoraki, PhD, DESA
principal investigator · Aretaieion University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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