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

Al-Azhar University

Status and phase: Not yet enrolling; Phase 3

Conditions: Caesarean Delivery; Hypotension Postprocedural

Treatments: Procedure: Classic group; Procedure: Sequential group

Study type: Interventional

Funder types: Other

Identifiers

NCT07327866

RC. 16.10.2025

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Classic group

Experimental group

Description:

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.

Treatment:

Procedure: Classic group

Sequential group

Active Comparator group

Description:

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.

Treatment:

Procedure: Sequential group