Working… Menu

The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Navil Sethna, Boston Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Obstruction of Pelviureteric Junction Device: Ropivacaine wound catheter Device: Saline wound catheter Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Actual Study Start Date : April 24, 2009
Actual Primary Completion Date : September 6, 2011
Actual Study Completion Date : September 6, 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Morphine [ Time Frame: 48 hours ]
    Total amount of morphine used in the first 48hrs immediately after surgery

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00930046

Layout table for location information
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
Sponsors and Collaborators
Boston Children's Hospital
Children's Hospital Medical Center, Cincinnati
Layout table for investigator information
Principal Investigator: Navil Sethna, MD Boston Children's Hospital
Layout table for additonal information
Responsible Party: Navil Sethna, Senior Associate in Perioperative Anesthesia, Boston Children's Hospital Identifier: NCT00930046    
Other Study ID Numbers: 08-11-0506
First Posted: June 30, 2009    Key Record Dates
Results First Posted: April 28, 2020
Last Update Posted: April 28, 2020
Last Verified: February 2020
Keywords provided by Navil Sethna, Boston Children's Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Ureteral Obstruction
Multicystic Dysplastic Kidney
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urogenital Abnormalities
Kidney Diseases, Cystic
Congenital Abnormalities
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents