A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

NCT02501135 | Completed Results

• 1 other identifier: IRB 15-00396
• Study Type: observational
• Target: 281
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

Femoral nerve blocks; children; knee and thigh surgery

Outcome Measures

Primary Outcomes (4)

• Concentration of Local Anesthetic Injected for Femoral Nerve Block

  length of surgery

• Total mg of Local Anesthetic Injected for Femoral Nerve Block

  length of surgery

• Intraoperative Tylenol Administered

  Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.

  length of surgery

• Post-operative Opioids Administered

  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 Outcomes (3)

• Time to Discharge From PACU

  Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour

• Post-operative Pain Scale Using FLACC

  1 hour post-op

• Post-operative Pain Scale Using VAS

  1 hour post-op

Study Arms (1)

Femoral Nerve Blocks

Patients who receive ropivacaine or bupivacaine during femoral nerve block.

Procedure: Femoral nerve block with ropivacaine or bupivacaine

Interventions

Femoral nerve block with ropivacaine or bupivacaine PROCEDURE

Femoral Nerve Blocks

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giorgio Veneziano: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Nationwide Children's Hospital

heather.dellinger@nationwidechildrens.org

6147222997

Study Officials

• Giorgio Veneziano, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: July 17, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 6, 2019
• Results First Posted: March 6, 2019

Record last verified: 2018-11