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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-03-30

Brief Summary

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

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Detailed Description

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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

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Cesarean Section Complications

Study Design

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Allocation Method

NA

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard dose of Hyberbaric Bupivacaine in Elective cesarean section

1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl).

Group Type ACTIVE_COMPARATOR

Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

Intervention Type DRUG

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

2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).

Group Type ACTIVE_COMPARATOR

Hyperbaric Bupivacaine HCl 0.5% 10 mg

Intervention Type DRUG

2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Other Intervention Names

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Standard dose of hyperbaric bupivacaine 20% reduced dose of hyperbaric bupivacaine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes