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

December 26, 2025 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Egypt
      • Cairo, Egypt, Egypt, 11865
        • Al-Azhar University
        • Contact:
        • Principal Investigator:
          • Hany Baumy, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of post-spinal hypotension
Time Frame: Assessed during the first 15 minutes after the intrathecal injection.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to first hypotensive episode
Time Frame: Measured continuously for 15 minutes following the intrathecal injection.
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
Time Frame: Assessed within 15 minutes after intrathecal injection.
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
Time Frame: Assessed within 15 minutes after spinal administration.
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
Time Frame: Evaluated from injection until block stabilization within 20 minutes.
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
Time Frame: Monitored intraoperatively up to delivery.
Incidence of intraoperative nausea or vomiting related to hypotension or anesthetic effect.
Monitored intraoperatively up to delivery.
Maternal satisfaction
Time Frame: Assessed after delivery before discharge from recovery.
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)
Time Frame: Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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