CompletedNot Applicable

Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Canada32 participantsStarted 2010-11

Plain-language summary

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Who can participate

Age range

1 Month – 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: * American Society of Anesthesiologists (ASA) classification score 1-3 * age 1 month to 6 years inclusive Exclusion Criteria: * children undergoing an additional surgical procedure at an anatomical location not covered by a unilateral TAP block during the same anesthetic * children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection * postoperative admission to the intensive care unit * children with a known allergy to bupivacaine * children with a history of chronic abdominal pain requiring opioid analgesics * children with known renal insufficiency * children with known impaired hepatic function * children with known impaired cardiac function * children known hypersensitivity to sodium metabisulfite

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

Requirement for Morphine Post-surgery.

Timeframe: Time in recovery room, approximately 60-90 minutes.

Trial details

NCT IDNCT01243593

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2017-10-25

View on ClinicalTrials.gov More Anesthesia trials

Who can participate

Age range

1 Month – 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.