Randomised controlled trial of spinal anaesthesia with bupivacaine or 2-chloroprocaine during caesarean section.
S Maes, M Laubach, J Poelaert
https://pubmed.ncbi.nlm.nih.gov/26608876Actively Recruiting
Led by Aretaieion University Hospital · Updated on 2025-07-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
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
Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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)
Total: 1 location
1
Aretaieion University Hospital
Athens, Greece, 11528
Actively Recruiting
K
Kassiani Theodoraki, PhD, DESA
M
Marianna Mavromati, MD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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