NCT07140640

Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 333 (estimated)
• Sponsor: Aswan University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.

Detailed description

This an interventional study comparing effect of Standard dose of Hyperbaric bupivacaine with 20% reduction of dose of Hyperbaric Bupivacaine in Elective Cesarean Delivery. First, we determaine if the patient ( low - moderate - high ) risk to High spinal complication or not according to : Age-weight-BMI-Height. Then , Randomly we gave the patients " Full dose of Hyperbaric Bupivacaine OR 20% reduction of hyperbric Bupivacaine " in spinal anaethsia . Post anesthesia evaluation: to assess incomplete sensory and/or motor blockade after spinal anesthesia for cesarean section is the Bromage Scale for motor blockade and a sensory block assessment using pinprick or cold sensation. 1. Bromage Scale for Motor Blockade: This scale assesses the degree of motor block in the lower limbs: * Grade 0: No paralysis, full flexion of knees and feet. * Grade 1: Inability to raise extended legs; can move knees and feet. * Grade 2: Inability to flex knees; can move feet. * Grade 3: Complete paralysis of the lower limbs. Incomplete motor blockade would typically be Bromage 1 or 2. 2. Sensory Block Assessment: * Sensory block is often assessed using a pinprick test or cold sensation (ice or alcohol swab). * Levels are recorded using dermatome levels (T10, T6, T4, etc.). * Incomplete sensory block means failure to achieve adequate sensory block (T4-T6 for cesarean section), requiring additional analgesia or conversion to general anesthesia.

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-03-15
• Completion: 2026-03-30
• First posted: 2025-08-25
• Last updated: 2025-08-25

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study