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

NCT ID: NCT07327866

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-28
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Classic group

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.

Group Type: EXPERIMENTAL

Classic group

Intervention Type: 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.

Sequential group

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.

Group Type: ACTIVE_COMPARATOR

Sequential group

Intervention Type: 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.

Interventions

Classic group

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.

Intervention Type: PROCEDURE

Sequential group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: collaborator

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al-Azhar University

Cairo, Egypt, Egypt

Countries

Egypt

Central Contacts

Neveen A Kohaf, Ph.D

Role: CONTACT

nevenabdo@azhar.edu.eg

+201060383012

Facility Contacts

Neveen A. Kohaf, PhD

Role: primary

nevenabdo@azhar.edu.eg

01060383012

Other Identifiers

RC. 16.10.2025

Identifier Type: -

Identifier Source: org_study_id