A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal An… (NCT07035184) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries
Egypt60 participantsStarted 2025-08-01
Plain-language summary
This prospective randomized double-blinded controlled trial will include 60 pediatric patients aged 1 - 6 years old, both sexes, with American society of anesthesiologists (I and II) and undergoing elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Patients will be randomly divided into two equal groups: Weight-based dosing (Group A) and age-based dosing group (Group B). Both groups will receive hyperbaric bupivacaine 0.5%. The aim of the study is to evaluate the effectiveness of using age based dosing of Bupivacaine compared with standard method of weight based dosing in pediatric spinal anesthesia.
Who can participate
Age range
1 Year – 6 Years
Sex
ALL
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:
* Children aged 1-6 years
* Both genders.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
Exclusion Criteria:
* Guardian refusal.
* Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention)
* Children with neuromuscular disorders or high intracranial pressure.
* Children with spinal deformities or morbid obesity (body mass index (BMI) above the 99th percentile).
* Children with a history or family history of coagulation disorders.
* Children with local infection at the site of skin puncture for spinal anesthesia.
* Children with known allergy to Bupivacaine.
* Surgeries requiring Trendelenburg or prone position.
* Unexpected prolongation of surgery \> 90 minutes
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
1
The peak sensory level
Timeframe: Assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch up to 30 minutes after subarachnoid block