Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
NCT07140640 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 333
Last updated 2025-08-25
Summary
Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.
Conditions
- Cesarean Section Complications
Interventions
- DRUG
-
Hyperbaric Bupivacaine HCl 0.5% 12.5 mg
1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl).
- DRUG
-
Hyperbaric Bupivacaine HCl 0.5% 10 mg
2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).
Sponsors & Collaborators
-
Aswan University
lead OTHER
Principal Investigators
-
Ayman Mohamdy Eldemerdash, consultant · Aswan University
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-15
- Primary Completion
- 2026-03-15
- Completion
- 2026-03-30
- FDA Drug
- Yes
Countries
- Egypt
Study Locations
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