A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501135
• Other study ID #: IRB 15-00396
• Status: Completed
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2018
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Femoral nerve block with ropivacaine or bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Giorgio Veneziano

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of Local Anesthetic Injected for Femoral Nerve Block		length of surgery
Primary	Total mg of Local Anesthetic Injected for Femoral Nerve Block		length of surgery
Primary	Intraoperative Tylenol Administered	Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.	length of surgery
Primary	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	Time to Discharge From PACU		Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
Secondary	Post-operative Pain Scale Using FLACC	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
Secondary	Post-operative Pain Scale Using VAS	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