NCT06376058

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

April 17, 2024

Last Update Submit

July 20, 2025

Conditions

Cesarean SectionLocal Anesthetic

Outcome Measures

Primary Outcomes (18)

  • 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 Outcomes (21)

  • Neonatal Apgar score at 1 minute

    1 minute post delivery

  • Neonatal Apgar score at 5 minutes

    1 minute post delivery

  • neonatal blood gases

    1 minute post delivery

  • incidence of neonatal acidosis

    1 minute post delivery

  • incidence of hypotension

    intraoperative

  • +16 more secondary outcomes

Study Arms (2)

chloroprocaine group

ACTIVE COMPARATOR

intrathecal fixed dose of chloroprocaine 1%

Drug: Chloroprocaine 1% Injectable Solution

ropivacaine group

ACTIVE COMPARATOR

intrathecal fixed dose of ropivacaine 0.75%

Drug: Ropivacaine 0.75% Injectable Solution

Interventions

Chloroprocaine 1% Injectable SolutionDRUG

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

chloroprocaine group
Ropivacaine 0.75% Injectable SolutionDRUG

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

ropivacaine group

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieion University Hospital

Athens, 11528, Greece

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26608876BACKGROUND

  • 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.

    PMID: 30237085BACKGROUND

  • 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.

    PMID: 33776083BACKGROUND

  • 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.

    PMID: 37227957BACKGROUND

MeSH Terms

Interventions

chloroprocaineRopivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kassiani Theodoraki, PhD, DESA

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD, DESA

CONTACT

6974634162ktheodoraki@hotmail.com

Marianna Mavromati, MD

CONTACT

marimavr14@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 19, 2024

Study Start

January 10, 2024

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations

GR(1)