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NCT Number: NCT07140640

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

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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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aswan university

Aswān, Aswan Governorate, 000, Egypt

About this study

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.

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

Drug

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

Other names: Standard dose of hyperbaric bupivacaine

Hyperbaric Bupivacaine HCl 0.5% 10 mg

Drug

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

Other names: 20% reduced dose of hyperbaric bupivacaine

Primary outcomes

  1. 1-Reduced Incidence of HSB

    Time frame: operation time

    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).

  2. 1-Reduced Incidence of HSB

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Mahmoud Ismail, Resident

CONTACT

[email protected]

+201141431136

Soudy Salah Hammad, consultant

CONTACT

[email protected]

+201014761523

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2025
Registry last updated
Aug 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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