20% Lower Bupivacaine Dose May Cut High Spinal Block in Cesarean Deliveries
Official title: Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
Run by Aswan University · NCT07140640 · Data updated 2026-11-12
This trial tests whether reducing intrathecal hyperbaric bupivacaine by 20% lowers the risk of high spinal block in cesarean deliveries for pregnant women.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 666 (estimated) |
| Sponsor | Aswan University Academic / other |
| Locations | 1 site (Aswān, Aswan Governorate) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 15, 2026 |
| Study ends | September 30, 2026 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT07140640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 18-45 undergoing cesarean delivery, ASA II-III, without twin gestation or spinal anesthesia contraindications.
✕Probably not a fit
Patients with conditions or risk factors not mitigated by dose reduction, or those who do not experience high spinal blocks anyway, may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind study compares a reduced-dose intrathecal hyperbaric bupivacaine regimen (10 mg) to a standard-dose regimen (12.5 mg) in women undergoing cesarean delivery. Participants are stratified by a preoperative risk-prediction model before randomization to evaluate whether dose awareness affects outcomes. The primary outcome is the incidence of high spinal block, with both groups receiving concurrent fentanyl to standardize analgesia. The trial is conducted at Aswan University, enrolling ASA II-III pregnant patients aged 18-45 without twin pregnancies or contraindications to spinal anesthesia. Results may clarify if a smaller dose can maintain anesthesia safety while reducing adverse block levels.
Why it matters
Potential benefit: If successful, patients could experience fewer high spinal blocks and related complications during cesarean delivery.
How similar studies have gone: Previous work in regional anesthesia supports dose tweaks to balance block height and safety, but this exact risk-stratified, dose-reduction approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Pregnant women aged 18-45 years. * ASA physical status II-III. Exclusion Criteria: * • Twin pregnancies. * Contraindications to spinal anesthesia (e.g., coagulopathy, infection). * Patients with incomplete preoperative data for risk stratification.
Where it's running
-
Aswan university
Aswān, Aswan Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Eman Mahmoud Ismail, Resident
- Email: emanmahmoud37@gmail.com
- Phone: +201141431136
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.