Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

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.
 
ClinicalTrials.gov Identifier: NCT02501135
Recruitment Status : Completed
First Posted : July 17, 2015
Results First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Giorgio Veneziano, Nationwide Children's Hospital

Brief Summary:
The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.

Condition or disease Intervention/treatment
Postoperative Pain Procedure: Femoral nerve block with ropivacaine or bupivacaine

Layout table for study information
Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Investigation of Safety and Efficacy From Increasing Concentrations of Local Anesthetic in Pediatric Femoral Nerve Blocks
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Group/Cohort Intervention/treatment
Femoral Nerve Blocks
Patients who receive ropivacaine or bupivacaine during femoral nerve block.
Procedure: Femoral nerve block with ropivacaine or bupivacaine



Primary Outcome Measures :
  1. Concentration of Local Anesthetic Injected for Femoral Nerve Block [ Time Frame: length of surgery ]
  2. Total mg of Local Anesthetic Injected for Femoral Nerve Block [ Time Frame: length of surgery ]
  3. Intraoperative Tylenol Administered [ Time Frame: length of surgery ]
    Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.

  4. Post-operative Opioids Administered [ Time Frame: in PACU (1 hr post-op) ]
    Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine


Secondary Outcome Measures :
  1. Time to Discharge From PACU [ Time Frame: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour ]
  2. Post-operative Pain Scale Using FLACC [ Time Frame: 1 hour post-op ]
    The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.

  3. Post-operative Pain Scale Using VAS [ Time Frame: 1 hour post-op ]
    The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."



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:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone anesthesia and received a femoral nerve block at Nationwide Children'ts Hospital from 2010-2015 utilizing our EMR - PICIS.
Criteria

Inclusion Criteria:

  • ASA physical status I or II
  • Age < or equal to 18 years of age at time of femoral nerve block
  • Femoral nerve block performed from 2010-2015

Exclusion Criteria:

  • ASA physical status > II
  • Co-morbid diseases (cardiac, pulmonary, neurological disease)
  • Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone

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 ClinicalTrials.gov identifier (NCT number): NCT02501135


Sponsors and Collaborators
Giorgio Veneziano
Investigators
Layout table for investigator information
Principal Investigator: Giorgio Veneziano, MD Nationwide Children's Hospital
  Study Documents (Full-Text)

Documents provided by Giorgio Veneziano, Nationwide Children's Hospital:
Study Protocol  [PDF] May 21, 2015

Layout table for additonal information
Responsible Party: Giorgio Veneziano, Clinical Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02501135    
Other Study ID Numbers: IRB 15-00396
First Posted: July 17, 2015    Key Record Dates
Results First Posted: March 6, 2019
Last Update Posted: March 6, 2019
Last Verified: November 2018
Keywords provided by Giorgio Veneziano, Nationwide Children's Hospital:
Femoral nerve blocks
children
knee and thigh surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents