Comparing Intrathecal Chloroprocaine 1% and Ropivacaine 0.75% for Elective Cesarean Section Anesthesia
Led by Aretaieion University Hospital · Updated on 2025-07-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
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 participants 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
Research Team
K
Kassiani Theodoraki, PhD, DESA
M
Marianna Mavromati, MD
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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
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
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)
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
Comparison of analgesic efficacy of intrathecal 1% 2-chloroprocaine with or without fentanyl in elective caesarean section: A prospective, double-blind, randomised study.
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...