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NCT00930046

The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

Terminated NA Results posted Last updated 28 April 2020
What this trial tests

NA trial testing Ropivacaine wound catheter in Obstruction of Pelviureteric Junction in 15 participants. Terminated before completion.

Timeline
24 April 2009
Primary endpoint
6 September 2011
6 September 2011

Quick facts

Lead sponsorBoston Children's Hospital
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment15
Start date24 April 2009
Primary completion6 September 2011
Estimated completion6 September 2011
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston Children's Hospital

Who can join

Adults 3 Months to 14, any sex, with Obstruction of Pelviureteric Junction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Morphine Primary · 48 hours

Total amount of morphine used in the first 48hrs immediately after surgery

GroupValue95% CI
Ropivacaine Group2.2± 1.8
Normal Saline Group3.5± 1.8
FLACC Pain Intensity [Faces Legs Activity Cry Consolability] 0-10 Points Secondary · 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.

GroupValue95% CI
Ropivacaine Group1.3± 0.7
Normal Saline Group1.9± 1.8

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Boston Children's Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00930046.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing