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

Incidence of Post-Spinal Anaesthesia Hypotension in Caesarean Delivery: A Randomized Trial of Classic Versus Sequential Spinal Technique

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypotension Postprocedural; Caesarean Delivery
• Intervention / Treatment: Procedure: Classic group; Procedure: Sequential group

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Neveen A Kohaf, Ph.D; Phone Number: +201060383012; Email: nevenabdo@azhar.edu.eg

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11865
      • Al-Azhar University
      • Contact: Neveen A. Kohaf, PhD; Phone Number: 01060383012; Email: nevenabdo@azhar.edu.eg
      • Principal Investigator: Hany Baumy, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first hypotensive episode	The interval between the time of intrathecal injection and the first recorded episode of hypotension. This reflects how long each technique maintains stable blood pressure before any drop occurs.	Measured continuously for 15 minutes following the intrathecal injection.
Number of hypotensive episodes	The total count of discrete hypotensive events occurring within the observation period after spinal anesthesia. This indicates the frequency and severity of blood pressure fluctuations.	Assessed within 15 minutes after intrathecal injection.
Total vasopressor dose	The total amount of phenylephrine and/or ephedrine administered to correct hypotension during the observation period, serving as an indirect measure of hemodynamic stability.	Assessed within 15 minutes after spinal administration.
Maximal sensory block level and time to T4	Determines the highest dermatomal sensory level achieved and the time required to reach the T4 level, indicating block quality and onset characteristics of the anesthetic technique. Maximal sensory block level is assessed by testing loss of sensation to cold or pinprick over the trunk in a cephalad-caudal direction and mapping the highest blocked dermatome (e.g., using an alcohol swab or pin along the midline and comparing to known dermatomal levels such as T4 at the nipple line). Time to T4 is measured as the interval in minutes from completion of intrathecal injection to the first assessment at which loss of sensation reaches the T4 dermatome, documented with the same stimulus and dermatomal map.	Evaluated from injection until block stabilization within 20 minutes.
Maternal nausea and vomiting	Incidence of intraoperative nausea or vomiting related to hypotension or anesthetic effect.	Monitored intraoperatively up to delivery.
Maternal satisfaction	Maternal satisfaction will be evaluated using a 5-point Likert scale addressing analgesia adequacy, comfort, and overall anesthesia experience. Each participant will rate her satisfaction as follows: 1 for "very dissatisfied," indicating poor pain control and significant discomfort; 2 for "dissatisfied," reflecting partial relief with ongoing discomfort; 3 for "neutral," denoting acceptable but unremarkable pain relief; 4 for "satisfied," representing good pain control with minimal discomfort; and 5 for "very satisfied," indicating excellent analgesia and a fully positive anesthesia experience.	Assessed after delivery before discharge from recovery.
Neonatal outcomes (Apgar scores and umbilical artery pH)	Measures neonatal wellbeing through 1-minute and 5-minute Apgar scores and umbilical artery blood pH to assess the effect of maternal hemodynamics on fetal oxygenation.	Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): January 28, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 26, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Classic; Sequential Spinal Technique
• Other Study ID Numbers: RC. 16.10.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No