Comparison of Classic and Sequential Spinal Techniques for Preventing Hypotension During Cesarean Delivery.

NCT07327866 | Not Yet Recruiting Phase 3

• 1 other identifier: RC. 16.10.2025
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. We therefore designed this study to compare the incidence of post-spinal hypotension between the classic single-shot spinal and the sequential fractionated spinal techniques in elective cesarean delivery.

Conditions

Caesarean Delivery; Hypotension Postprocedural

Keywords

Classic; Sequential Spinal Technique

Outcome Measures

Primary Outcomes (1)

• Incidence of post-spinal hypotension

  Occurrence of maternal hypotension within 15 minutes after intrathecal injection, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or an absolute SBP below 90 mmHg. This outcome directly measures the hemodynamic stability achieved by each spinal technique.

  Assessed during the first 15 minutes after the intrathecal injection.

Secondary Outcomes (7)

• Time to first hypotensive episode

  Measured continuously for 15 minutes following the intrathecal injection.

• Number of hypotensive episodes

  Assessed within 15 minutes after intrathecal injection.

• Total vasopressor dose

  Assessed within 15 minutes after spinal administration.

• Maximal sensory block level and time to T4

  Evaluated from injection until block stabilization within 20 minutes.

• Maternal nausea and vomiting

  Monitored intraoperatively up to delivery.

Study Arms (2)

Classic group

EXPERIMENTAL

In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution.

Procedure: Classic group

Sequential group

ACTIVE COMPARATOR

In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution.

Procedure: Sequential group

Interventions

Classic group PROCEDURE

In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution.

Classic group

Sequential group PROCEDURE

In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution.

Sequential group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Caesarean Delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult women aged 18-45 years.
• ASA physical status II-III.
• Scheduled for elective cesarean section under standardized spinal anesthesia.

You may not qualify if:

• Allergy to local anesthetics.
• Emergency cesarean section.
• Contraindication to spinal anesthesia (e.g., coagulopathy, infection at the puncture site).
• Preexisting hypertension on medication or pre-eclampsia with severe features.
• Known cardiac disease accompanied by hemodynamic instability.
• Allergy to study drugs.
• Fetal distress or non-reassuring cardiotocography (CTG).
• BMI \>40 kg/m².
• Refusal to sign informed consent.

Sponsors & Collaborators

• Al-Azhar University: lead
• Benha University: collaborator

Study Sites (1)

Al-Azhar University

Cairo, Egypt, 11865, Egypt

Location

Central Study Contacts

Neveen A Kohaf, Ph.D

CONTACT

+201060383012; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 8, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)