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Cesarean Sectionannie-marianaNCT06376058

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

A study testing Chloroprocaine 1% Injectable Solution and Ropivacaine 0.75% Injectable Solution in people with Cesarean Section and Local Anesthetic, run by Aretaieion University Hospital at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 48 years, women only
Conditions the study is for
Cesarean Section, Local Anesthetic
What is being tested?
Chloroprocaine 1% Injectable Solution and Ropivacaine 0.75% Injectable Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
10 Jan 2024to 10 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 48 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kassiani Theodoraki, PhD, DESA contact

6974634162

ktheodoraki@hotmail.com

Marianna Mavromati, MD contact

marimavr14@gmail.com

Greece1 site, 1 recruiting

  • Aretaieion University Hospital

    Athens, 11528

    Kassiani Theodoraki, PhD, DESA, 6974634162, ktheodoraki@hotmail.com

    Marianna Mavromati, MD, marimavr14@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: 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

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.

Being tested
Chloroprocaine 1% Injectable Solution, Ropivacaine 0.75% Injectable Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chloroprocaine 1% Injectable SolutionDrug

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

  • Ropivacaine 0.75% Injectable SolutionDrug

    • in parturients allocated to the ropivacaine group, a fixed dose of ropivacaine 0.75% will be administered intrathecally
Study groups in NCT06376058
Study groupRoleWhat they receive
chloroprocaine groupActive comparatorintrathecal fixed dose of chloroprocaine 1%
Receives: Drug: Chloroprocaine 1% Injectable Solution
ropivacaine groupActive comparatorintrathecal fixed dose of ropivacaine 0.75%
Receives: Drug: Ropivacaine 0.75% Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: 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

    Measured: intraoperative

  4. level of sensory block every 3 min

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

    Measured: 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

    Measured: intraoperative

  6. highest level of sensory block

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: intraoperative

  10. pain at neonatal delivery

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

    Measured: intraoperative

  11. pain at peritoneal manipulation

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

    Measured: 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

    Measured: 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

    Measured: 1 hour postoperatively

  14. need for rescue analgesia intraoperatively

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

    Measured: 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

    Measured: intraoperative

  16. Bromage scale every 15 min

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

    Measured: intraoperative

  17. duration of motor block

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

    Measured: 1 hour postoperatively

  18. duration of staying in PACU

    duration of parturient stay in PACU

    Measured: 2 hours postoperatively

Secondary outcomes (21)

  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

    Measured: 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

    Measured: 1 minute post delivery

  3. neonatal blood gases

    fetal cord blood analysis will be performed immediately post-delivery

    Measured: 1 minute post delivery

  4. incidence of neonatal acidosis

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

    Measured: 1 minute post delivery

  5. incidence of hypotension

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

    Measured: intraoperative

  6. incidence of bradycardia

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

    Measured: intraoperative

  7. need for vasoconstrictor

    any need for vasoconstrictor during the operation will be recorded

    Measured: intraoperative

  8. need for atropine

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

    Measured: intraoperative

  9. incidence of nausea/vomiting

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

    Measured: intraoperative

  10. incidence of dizziness

    any occurence of dizziness during the operation will be recorded

    Measured: intraoperative

  11. incidence of drowsiness

    any occurence of drowsiness during the operation will be recorded

    Measured: intraoperative

  12. incidence of discomfort

    any occurence of discomfort during the operation will be recorded

    Measured: intraoperative

  13. incidence of shivering

    any occurence of shivering during the operation will be recorded

    Measured: intraoperative

  14. need for rescue analgesia in PACU

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

    Measured: 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

    Measured: 2 hours postoperatively

  16. incidence of neurological symptoms during hospital stay

    incidence of neurological symptoms during hospitalization will be recorded

    Measured: 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

    Measured: 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

    Measured: 2 months after discharge

  19. time from spinal anesthesia to mobilization

    time from spinal anesthesia to mobilization of parturient will be recorded

    Measured: 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

    Measured: 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

    Measured: 1 hour postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start10 Jan 2024
  3. Primary completion10 Jan 2026 (estimated)
  4. Study completion10 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376058
Sponsor's protocol ID
434/06-06-2022
Acronym
annie-mariana
Status last verified
Jul 2025
First submitted
17 Apr 2024
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Chloroprocaine 1% Injectable Solution and Ropivacaine 0.75% Injectable Solution in people with Cesarean Section and Local Anesthetic, run by Aretaieion University Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kassiani Theodoraki, PhD, DESA (6974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from spinal anesthesia to T10 block (min) (time frame: intraoperative). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376058, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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