Comparing two local anesthetics for cesarean sections
Intrathecal Use of Chloroprocaine 1% and Ropivacaine 0,75% During Elective Cesarean Section. A Comparative Study
NA · Aretaieion University Hospital · NCT06376058
This study is testing whether a new local anesthetic called chloroprocaine works better than the usual one, ropivacaine, for women having cesarean sections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Aretaieion University Hospital (other) |
| Locations | 1 site (Athens) |
| Trial ID | NCT06376058 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of chloroprocaine 1% and ropivacaine 0.75% when administered intrathecally during elective cesarean sections. It is a prospective randomized study that will evaluate the anesthetic outcomes of both drugs in parturients undergoing combined spinal-epidural anesthesia. The study seeks to determine if the newer formulation of chloroprocaine, which is now considered safe, can provide advantages over the commonly used ropivacaine. The trial will include adult women with singleton pregnancies who meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women with singleton pregnancies who are scheduled for elective cesarean sections and have an ASA classification of I-II.
Not a fit: Patients who may not benefit from this study include those with high ASA classifications, multiple gestations, or any contraindications for regional anesthesia.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anesthetic option for women undergoing cesarean sections.
How similar studies have performed: While chloroprocaine has been used in the past, its recent reformulation makes this approach novel and untested in the context of elective cesarean sections.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Athens
- Aretaieion University Hospital — Athens, Greece (RECRUITING)
Study contacts
- Principal investigator: Kassiani Theodoraki, PhD, DESA — Aretaieion University Hospital
- Study coordinator: Kassiani Theodoraki, PhD, DESA
- Email: ktheodoraki@hotmail.com
- Phone: 6974634162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cesarean Section, Local Anesthetic