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Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.

ConditionCesarean Section Complications
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAswan University

About this trial

Effect of a 20% Reduction in Hyperbaric Bupivacaine Dose on High Spinal Block Incidence in Cesarean Delivery: A Risk-Stratified Randomized Controlled Trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Pregnant women aged 18-45 years.

ASA physical status II-III.

Disqualifiers

• Twin pregnancies.

Contraindications to spinal anesthesia (e.g., coagulopathy, infection).

Patients with incomplete preoperative data for risk stratification.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Hyperbaric Bupivacaine HCl 0.5% 12.5 mg

    Drug

    1- Standard dose group: receiving the typical dose of hyperbaric bupivacaine (12.5 mg hyperbaric bupivacaine + 25 mcg fentanyl).

  • Hyperbaric Bupivacaine HCl 0.5% 10 mg

    Drug

    2- Reduced dose group: receiving a20% reduced dose of hyperbaric bupivacaine (10 mg hyperbaric bupivacaine + 25 mcg fentanyl).

Treatment groups

333 Participants
are divided into 2 treatment groups
Group A: Standard dose of Hyberbaric Bupivacaine in Elective cesarean sectionActive comparator 1 intervention
Group B: Reduced dose group in Elective cesarean sectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

1-Reduced Incidence of HSB

1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension \>30% below baseline).

Time frame
operation time
2

1-Reduced Incidence of HSB

1-reduced Incidence of HSB, defined as a sensory block level exceeding T4 within 15 minutes post-administration, accompanied by hemodynamic instability (e.g., hypotension \>30% below baseline).

Time frame
first 20 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aswan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: