A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Femoral nerve block with ropivacaine or bupivacaine

• Registration Number: NCT02501135
• Lead Sponsor: Giorgio Veneziano

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-28
• Study Start: 2015-06
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2018-02-20
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-06
• Last Update Submitted: 2018-11-06
• Results First Posted: 2019-03-06
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Femoral Nerve Blocks	Femoral nerve block with ropivacaine or bupivacaine	Patients who receive ropivacaine or bupivacaine during femoral nerve block.

Primary Outcome Measures

Name	Time	Method
Concentration of Local Anesthetic Injected for Femoral Nerve Block	length of surgery
Intraoperative Tylenol Administered	length of surgery	Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
Total mg of Local Anesthetic Injected for Femoral Nerve Block	length of surgery
Post-operative Opioids Administered	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

Name	Time	Method
Post-operative Pain Scale Using FLACC	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.
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 VAS	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."