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NCT Number: NCT06376058

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

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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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chloroprocaine 1% Injectable Solution

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

Ropivacaine 0.75% Injectable Solution

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

Primary outcomes

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

    Time frame: intraoperative

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

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

    Time frame: intraoperative

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

  3. Time of spinal anesthesia to Bromage =3

    Time frame: intraoperative

    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

  4. level of sensory block every 3 min

    Time frame: intraoperative

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

  5. level of sensory block every 15 min

    Time frame: intraoperative

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

  6. highest level of sensory block

    Time frame: intraoperative

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

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

    Time frame: intraoperative

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

  8. duration of sensory block

    Time frame: intraoperative

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

  9. pain at surgical incision

    Time frame: intraoperative

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

  10. pain at neonatal delivery

    Time frame: intraoperative

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

  11. pain at peritoneal manipulation

    Time frame: intraoperative

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

  12. pain at Post Anesthesia Care Unit (PACU) admission

    Time frame: 1 hour postoperatively

    pain at Post Anesthesia Care Unit (PACU) admission using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable

  13. pain at Post Anesthesia Care Unit (PACU) discharge

    Time frame: 1 hour postoperatively

    pain at Post Anesthesia Care Unit (PACU) discharge using VAS scale, where VAS=0, no pain; VAS=10, worst pain imaginable

  14. need for rescue analgesia intraoperatively

    Time frame: intraoperative

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

  15. Bromage scale every 3 min after spinal anesthesia

    Time frame: intraoperative

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

  16. Bromage scale every 15 min

    Time frame: intraoperative

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

  17. duration of motor block

    Time frame: 1 hour postoperatively

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

  18. duration of staying in PACU

    Time frame: 2 hours postoperatively

    duration of parturient stay in PACU

Secondary outcomes

  1. Neonatal Apgar score at 1 minute

    Time frame: 1 minute post delivery

    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

  2. Neonatal Apgar score at 5 minutes

    Time frame: 1 minute post delivery

    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

  3. neonatal blood gases

    Time frame: 1 minute post delivery

    fetal cord blood analysis will be performed immediately post-delivery

  4. incidence of neonatal acidosis

    Time frame: 1 minute post delivery

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

  5. incidence of hypotension

    Time frame: intraoperative

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

  6. incidence of bradycardia

    Time frame: intraoperative

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

  7. need for vasoconstrictor

    Time frame: intraoperative

    any need for vasoconstrictor during the operation will be recorded

  8. need for atropine

    Time frame: intraoperative

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

  9. incidence of nausea/vomiting

    Time frame: intraoperative

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

  10. incidence of dizziness

    Time frame: intraoperative

    any occurence of dizziness during the operation will be recorded

  11. incidence of drowsiness

    Time frame: intraoperative

    any occurence of drowsiness during the operation will be recorded

  12. incidence of discomfort

    Time frame: intraoperative

    any occurence of discomfort during the operation will be recorded

  13. incidence of shivering

    Time frame: intraoperative

    any occurence of shivering during the operation will be recorded

  14. need for rescue analgesia in PACU

    Time frame: 2 hours postoperatively

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

  15. time from spinal anesthesia to rescue analgesia in PACU

    Time frame: 2 hours postoperatively

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

  16. incidence of neurological symptoms during hospital stay

    Time frame: 5 days postoperatively

    incidence of neurological symptoms during hospitalization will be recorded

  17. incidence of neurological symptoms 2 months after the operation

    Time frame: 2 months after discharge

    incidence of neurological symptoms 2 months after discharge from the hospital will be recorded by phone communication

  18. incidence of low back pain

    Time frame: 2 months after discharge

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

  19. time from spinal anesthesia to mobilization

    Time frame: 2 days postoperatively

    time from spinal anesthesia to mobilization of parturient will be recorded

  20. mother's satisfaction from anesthesia

    Time frame: 1 day postoperatively

    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

  21. gynecologist's satisfaction

    Time frame: 1 hour postoperatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kassiani Theodoraki, PhD, DESA

CONTACT

[email protected]

6974634162

Marianna Mavromati, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Acronym: annie-mariana

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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