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

Not Applicable

Not yet recruiting

• Conditions: Cesarean Section Complications
• Interventions: Drug: Hyperbaric Bupivacaine HCl 0.5% 12.5 mg; Drug: Hyperbaric Bupivacaine HCl 0.5% 10 mg

• Registration Number: NCT07140640
• Lead Sponsor: Aswan University

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Study First Posted: 2025-08-25
• Last Update Posted: 2025-08-25
• Study Start: 2025-09-15
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 333

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Standard dose of Hyberbaric Bupivacaine in Elective cesarean section	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).
Reduced dose group in Elective cesarean section	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).

Primary Outcome Measures

Name	Time	Method
1-Reduced Incidence of HSB	first 20 minutes	1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension \>30% below baseline).

Trial Locations

Locations (1)

Aswan university; 🇪🇬 Aswān, Aswan Governorate, Egypt