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The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

NCT00930046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-04-28

Study results available
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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.

Conditions

  • Obstruction of Pelviureteric Junction

Interventions

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.

DEVICE

Saline wound catheter

19 gauge fenestrated wound catheter will be inserted into the fascial planes of the surgical site prior to wound closure

Sponsors & Collaborators

Principal Investigators

  • Navil Sethna, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-24
Primary Completion
2011-09-06
Completion
2011-09-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930046 on ClinicalTrials.gov