Comparison of Classic and Sequential Spinal Techniques for Preventing Hypotension During Cesarean Delivery.
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women aged 18-45 years.
ASA physical status II-III.
Scheduled for elective cesarean section under standardized spinal anesthesia.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Classic group
Procedure/SurgeryIn 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
Procedure/SurgeryIn 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 groups
94 Participants
are divided into 2 treatment groupsGroup A: Classic groupExperimental treatment 1 intervention
Group B: Sequential groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Assessed during the first 15 minutes after the intrathecal injection.Secondary outcomes
1
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.
Time frame
Measured continuously for 15 minutes following the intrathecal injection.2
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.
Time frame
Assessed within 15 minutes after intrathecal injection.3
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.
Time frame
Assessed within 15 minutes after spinal administration.4
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.
Time frame
Evaluated from injection until block stabilization within 20 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Al-Azhar University
Lead sponsor
Benha University
Collaborator
Source ClinicalTrials.gov
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