CompletedNot Applicable

Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioids in Spinal Anesthesia for Caesarean Section

Ukraine99 participantsStarted 2024-06-30

Plain-language summary

This study aimed to compare the effectiveness and safety of fractionated versus bolus administration of different doses of hyperbaric bupivacaine (0.06 and 0.07 mg/cm height) combined with opioids in spinal anesthesia for cesarean section, with detailed evaluation of maternal hemodynamic effects, block characteristics and side effects.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * singleton full-term pregnancy scheduled for cesarean section under spinal anesthesia * ASA physical status II-III * age 18-50 years * height from 140 to 180 cm * body weight from 40 to 130 kg Exclusion Criteria: * patient refusal * contraindications to spinal anesthesia * allergy to amide-type local anesthetics

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hemodynamic Stability (systolic, diastolic and mean arterial pressure, heart rate)

Timeframe: Perioperative/Periprocedural - before spinal anesthesia and then during the cesarean section until its completion

Trial details

NCT IDNCT07249814

SponsorBogomolets National Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-15

View on ClinicalTrials.gov More Spinal Anesthesia for Cesarean Section trials