CompletedEarly Phase 1

Hyperbaric Prilocaine 2% vs Hyperbaric Bupivacaine 0.5% in Caesarean Section

Egypt142 participantsStarted 2024-10-09

Plain-language summary

Comparison between effects of hyperbaric bupivacaine 0.5% vs Hyperbaric prilocaine 2% in spinal anesthesia of women undergoing elective caesarean section such as onset time of sensory and motor block, duration of sensory and motor block, effects of maternal hemodynamics and expected side effects .

Who can participate

Age range

18 Years – 45 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

. Women aged 18-45 years.
. Patients with uncomplicated pregnancies.
. American society of anesthesiologist (ASA) physical status I or II.
. Height between 155 cm and 175 cm.
. Written informed consent provided. -

Exclusion criteria

. Patients with known allergies to local anesthetics.
. Contraindications to intrathecal anesthesia (e.g., infection at the injection site and coagulopathy).

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

Measurment of onset time and duration of sensory block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using pinprick sensation test in women undergoing caesarean section

Timeframe: 12 HOURS

2- Measurment of onset time and duration of motor block of Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% using modified bromage scale in women undergoing caesarean section

Timeframe: 12 hours

Trial details

NCT IDNCT06680167

SponsorSohag University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-05

View on ClinicalTrials.gov More Spinal Anesthesia trials