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

Aswan University

Status and phase: Not yet enrolling; Phase 4

Conditions: Cesarean Section Complications

Treatments: Drug: Hyperbaric Bupivacaine HCl 0.5% 10 mg; Drug: Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07140640

1084-3-25

Details and patient eligibility

About

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

Full 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.

Enrollment: 333 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Factorial Assignment

Masking: None (Open label)

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333 participants in 2 patient groups

Standard dose of Hyberbaric Bupivacaine in Elective cesarean section

Active Comparator group

Description:

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

Treatment:

Drug: Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

Reduced dose group in Elective cesarean section

Active Comparator group

Description:

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

Treatment:

Drug: Hyperbaric Bupivacaine HCl 0.5% 10 mg