Comparing different methods of administering pain relief during cesarean sections
Comparison Between Premixed, Sequential and Manually Mixed Administration of Intrathecal Fentanyl and Bupivacaine in Cesarean Section: A Randomized Controlled Study
This study tests which of three ways to give pain relief during cesarean sections works best for women having the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06820203 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of three different methods for administering intrathecal fentanyl and bupivacaine during cesarean sections: premixed, sequential, and manually mixed. The goal is to determine which method provides the best pain relief while minimizing adverse effects. By focusing on regional anesthesia techniques, the study aims to enhance postoperative analgesia and improve maternal outcomes. Participants will be women aged 18 to 40 scheduled for cesarean delivery under spinal anesthesia.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 with a BMI between 18.5 and 30, scheduled for a cesarean section under spinal anesthesia.
Not a fit: Patients with pre-existing conditions such as hypotension, bradycardia, or spinal deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for women undergoing cesarean sections.
How similar studies have performed: Previous studies have shown promising results with similar approaches to pain management in cesarean sections, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 40 years. * Height between 150 to175 cm. * Body mass index (BMI) between 18.5 and 30 kg/m2. * American Society of Anesthesiology (ASA) physical status II. * Scheduled for cesarean section under spinal anesthesia. Exclusion Criteria: * Pre-operation hypotension and bradycardia. * Preeclampsia. * Multiple pregnancy and macrosomia. * Complete or partial failed spinal. * Patients with skin infections at the site of injection. * Patients with coagulation disorders. * Patients with spinal deformities. * Patients having regional nerve block other than spinal anesthesia.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed S Elsharkawy, MD
- Email: mselsharkawy@med.tanta.edu.eg
- Phone: 00201148207870
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.