Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 45 Women only

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.

More Cesarean Section Complications trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment666 (estimated)
SponsorAswan University
Academic / other
Locations1 site (Aswān, Aswan Governorate)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedSeptember 15, 2026
Study endsSeptember 30, 2026
Registry record updatedAugust 26, 2026
Trial IDNCT07140640 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.