The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
Stopped early · Not applicable
Conditions studied: Obstruction of Pelviureteric Junction
In brief
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.
Key facts
- Study ID
- NCT00930046
- Run by
- Boston Children's Hospital
- People needed
- 15
- Starts
- 2009-04-24
- Expected to finish
- 2011-09-06
- Last updated by the study team
- 2020-04-28
Who can join
Age: 0 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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