Status:
TERMINATED
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Conditions:
Obstruction of Pelviureteric Junction
Eligibility:
All Genders
3-14 years
Phase:
NA
Brief 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 sur...
Detailed Description
The investigators hypothesize that continuous infusion of local anesthetic via a wound catheter would improve postoperative pain control after UPJ correction and diminish the adverse effects associate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00930046
Start Date
April 24 2009
End Date
September 6 2011
Last Update
April 28 2020
Active Locations (2)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229