A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

November 6, 2018 updated by: Giorgio Veneziano

A Retrospective Investigation of Safety and Efficacy From Increasing Concentrations of Local Anesthetic in Pediatric Femoral Nerve Blocks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Time Frame: length of surgery
length of surgery
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Time Frame: length of surgery
length of surgery
Intraoperative Tylenol Administered
Time Frame: length of surgery
Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
length of surgery
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
in PACU (1 hr post-op)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge From PACU
Time Frame: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
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.
1 hour post-op
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."
1 hour post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giorgio Veneziano

Investigators

  • Principal Investigator: Giorgio Veneziano, MD, Nationwide Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 15-00396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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