TerminatedNot Applicable

The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

Stopped: The institution transitioned from open surgical procedure to Robotic procedure

United States15 participantsStarted 2009-04-24

Plain-language summary

The investigators propose a prospective blinded randomized control trial (RCT) to assess the efficacy and safety of a simple method of continuous infusion of a local anesthetic, ropivacaine, via a surgical wound to control pain after ureteropelvic junction (UPJ) stenosis correction in children during the first 48 hrs after surgery. The investigators hypothesize that this technique will provide greater pain relief post-operatively and reduce the need for systemic opioid use along with a reduction in associated side effects of such analgesics.

Who can participate

Age range

3 Months – 14 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: * Diagnosis of UPJ stenosis requiring surgical repair * Ages 3 months to 14 years old * Guardians give consent and the child gives assent when appropriate * Both genders * All racial and ethnic groups Exclusion Criteria: * A history of chronic pain and/or use of chronic opioids and other analgesic(s) * If parents/patients or attending urologist request epidural analgesia or refuse to participate in the study * Impairment of cognition/neurologic, hepatic, renal, cardiovascular, endocrine, metabolic, and/or coagulation function * A history of any diagnosis of psychiatric disorders, including bipolar disorders by self-report or by guardian * A recent history of illicit chemical abuse within one week prior to surgical date * Participants known to be taking prescribed medications or over-the-counter medications known to affect pain perception such as central nervous system stimulants, hypnotics, sedatives, etc within 24 hours of planned surgical procedure

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

Morphine

Timeframe: 48 hours

Trial details

NCT IDNCT00930046

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09-06

Results submitted2020-02-11

View on ClinicalTrials.gov More Obstruction of Pelviureteric Junction trials