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The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

This study is currently recruiting participants.
Verified July 2012 by Children's Hospital Boston
Sponsor:
Collaborator:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Navil Sethna, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00930046
First received: June 29, 2009
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Obstruction of Pelviureteric Junction
 Device: Wound catheter
Device: wound catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine for the Management of Pain After Surgical Correction of Ureteropelvic Junction Stenosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Total amount of opioid used in the first 48hrs immediately after surgery [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessing pain scale scores (FLACC for patients <7 y.o., NRS for patients >7 y.o. and VAS for guardians), incidences of side effects all in the first 48hrs post-operatively. Finally assessing time to discharge home. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: May 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacaine group
Patients in this group will receive ropivacaine via the wound catheter for the first 48hrs after surgery
 Device: 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: 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

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  Eligibility

Ages Eligible for Study:   3 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930046

Contacts
Contact: Navil Sethna, MD 617-355-4146 navil.sethna@childrens.harvard.edu
Contact: Vanessa Young, RN 857-218-4657 vanessa.young@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Navil Sethna, MD     617-355-4146     navil.sethna@childrens.harvard.edu    
Contact: Jessica Solari, BA     857-218-5348     jessica.solari@childrens.harvard.edu    
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: David Moore, MD     513-252-3623     david.moore@cchmc.org    
Contact: Lindsay Schultz         lindsay.schultz@cchmc.org    
Sponsors and Collaborators
Children's Hospital Boston
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Navil Sethna, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Navil Sethna, Senior Associate in Perioperative Anesthesia, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00930046     History of Changes
Other Study ID Numbers: 08-11-0506
Study First Received: June 29, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
ropivacaine
pediatric
children
continuous
 wound
catheter
infusion
pyeloplasty

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013