Actively Recruiting

Phase Not Applicable
Age: 18Years - 48Years
FEMALE
ID06376058

Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0.75% During Elective Cesarean Section A Comparative Study

Led by Aretaieion University Hospital · Updated on 2025-07-22

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two local anesthetics, chloroprocaine 1% and ropivacaine 0.75%, used during elective cesarean sections. This randomized controlled trial aims to compare these drugs when administered intrathecally as part of combined spinal-epidural anesthesia, which is preferred for cesarean deliveries to avoid airway complications associated with general anesthesia. The study investigates how these anesthetics perform in terms of onset, sensory and motor block characteristics, and pain control during surgery. Participants will receive a fixed intrathecal dose of either chloroprocaine 1% or ropivacaine 0.75% during their cesarean section. The study is double-blind and randomized, with two groups receiving one of the anesthetics. Chloroprocaine has a quicker onset and was previously limited by safety concerns, but newer formulations are considered safe. Ropivacaine is commonly used in Greece. The trial focuses on the intraoperative period of the cesarean section under combined spinal-epidural anesthesia. During the study, researchers will monitor the time to achieve different levels of sensory and motor block, pain levels at various surgical stages, and the need for additional pain relief. They will also assess neonatal outcomes such as Apgar scores and blood gases, and record any side effects like nausea, dizziness, or neurological symptoms up to two months after surgery. The participant's satisfaction and recovery parameters, including time in the recovery unit and time to mobilization, will also be evaluated. The study is expected to last until January 2026.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 48Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult women aged 18 to 48 years
  • Classified as American Society of Anesthesiologists (ASA) physical status I or II
  • Single pregnancy with gestational age greater than 37 weeks
  • Scheduled for elective cesarean section
Not Eligible

You will not qualify if you...

  • American Society of Anesthesiologists (ASA) physical status greater than III
  • Age under 18 years
  • Single pregnancy with gestational age less than 37 weeks
  • Body Mass Index (BMI) greater than 40 kg/m2
  • Body weight less than 50 kg or greater than 100 kg
  • Height less than 150 cm or greater than 180 cm
  • Multiple pregnancy
  • Emergency delivery
  • Fetal abnormalities or distress
  • Pregnancy-related conditions such as preeclampsia, eclampsia, premature labor, or placental abnormalities
  • Pregnancy-related diseases like hepatic failure, pseudocholinesterase deficiency, or neuromuscular diseases
  • Lack of informed consent
  • Contraindications to regional anesthesia including thrombocytopenia, coagulation disorders, or allergy to local anesthetics

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of the cesarean section procedure and immediate recovery

Participants receive a fixed dose of either chloroprocaine 1% or ropivacaine 0.75% administered intrathecally during elective cesarean section under combined spinal-epidural anesthesia.

1 baseline visit (surgery day) and 1 follow-up visit during hospital stay

Follow-up

Duration - Up to 2 months after discharge

Participants are monitored for neurological symptoms, pain, and recovery outcomes after surgery up to 2 months post-discharge.

Approximately 3 visits (including assessments 1 day postoperatively, 2 days postoperatively, and 2 months after discharge)

Trial Site Locations

Total: 1 location

1

Aretaieion University Hospital

Athens, Greece, 11528

Actively Recruiting

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Research Team

K

Kassiani Theodoraki, PhD, DESA

M

Marianna Mavromati, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Andrea Saporito, Marcello Ceppi, Andreas Perren...

https://pubmed.ncbi.nlm.nih.gov/30237085

Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study.

Geeta Singariya, Kusum Choudhary, Manoj Kamal...

https://pubmed.ncbi.nlm.nih.gov/33776083