NCT07140640

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
333

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

August 25, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

August 22, 2025

Last Update Submit

August 22, 2025

Conditions

Cesarean Section Complications

Keywords

cesarean-20% hyperbaric bupivacaine

Outcome Measures

Primary Outcomes (2)

  • 1-Reduced Incidence of HSB

    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).

    operation time

  • 1-Reduced Incidence of HSB

    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).

    first 20 minutes

Study Arms (2)

Standard dose of Hyberbaric Bupivacaine in Elective cesarean section

ACTIVE COMPARATOR

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% 12.5 mg

Reduced dose group in Elective cesarean section

ACTIVE COMPARATOR

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

Drug: Hyperbaric Bupivacaine HCl 0.5% 10 mg

Interventions

Hyperbaric Bupivacaine HCl 0.5% 12.5 mgDRUG

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

Also known as: Standard dose of hyperbaric bupivacaine
Standard dose of Hyberbaric Bupivacaine in Elective cesarean section
Hyperbaric Bupivacaine HCl 0.5% 10 mgDRUG

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

Also known as: 20% reduced dose of hyperbaric bupivacaine
Reduced dose group in Elective cesarean section

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females planned for elective cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-45 years.
  • ASA physical status II-III.

You may not qualify if:

  • Twin pregnancies.
  • Contraindications to spinal anesthesia (e.g., coagulopathy, infection).
  • Patients with incomplete preoperative data for risk stratification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan university

Aswān, Aswan Governorate, 000, Egypt

Location

Related Publications (1)

  • Benjhawaleemas P, Sakolnagara BBN, Tanasansuttiporn J, Chatmongkolchart S, Oofuvong M. Risk prediction score for high spinal block in patients undergoing cesarean delivery: a retrospective cohort study. BMC Anesthesiol. 2024 Nov 11;24(1):406. doi: 10.1186/s12871-024-02799-w.

    PMID: 39528929BACKGROUND

Related Links

Study Officials

  • Ayman Mohamdy Eldemerdash, consultant

    Aswan University

    STUDY DIRECTOR

Central Study Contacts

Eman Mahmoud Ismail, Resident

CONTACT

+201141431136emanmahmoud37@gmail.com

Soudy Salah Hammad, consultant

CONTACT

+201014761523soudi.salah@aswu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 25, 2025

Study Start

September 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 30, 2026

Last Updated

August 25, 2025

Record last verified: 2025-04

Locations

EG(1)