The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
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|ClinicalTrials.gov Identifier: NCT00930046|
Recruitment Status : Terminated (The institution transitioned from open surgical procedure to Robotic procedure)
First Posted : June 30, 2009
Results First Posted : April 28, 2020
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Obstruction of Pelviureteric Junction||Device: Ropivacaine wound catheter Device: Saline wound catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine for the Management of Pain After Surgical Correction of Ureteropelvic Junction Stenosis|
|Actual Study Start Date :||April 24, 2009|
|Actual Primary Completion Date :||September 6, 2011|
|Actual Study Completion Date :||September 6, 2011|
Active Comparator: Ropivacaine group
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
Device: Ropivacaine wound catheter
19 gauge fenestrated wound catheter inserted into the fascial planes of the surgical site prior to skin closure with a separate exit site.
Other Name: ON-Q Catheter
Placebo Comparator: Normal Saline Group
Will receive an infusion of normal saline for 48hrs post-operatively via the wound catheter.
Device: Saline wound catheter
19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure
Other Name: ON-Q Catheter
- Morphine [ Time Frame: 48 hours ]Total amount of morphine used in the first 48hrs immediately after surgery
- FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points [ Time Frame: 48 hours post-operatively ]
Observational FLACC pain intensity assessment tool that consists of observing the Faces Legs Activity Cry Consolability (FLACC) by the bedside nursing staff. This pain assessment tool is validated in non-verbal children and children at 7 years and younger.
Minimum value is 0 and the maximum value is 10, where 0 represents no pain which is a better outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930046
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Navil Sethna, MD||Boston Children’s Hospital|