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Completed

NCT Number: NCT02501135

A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block

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.

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Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral nerve block with ropivacaine or bupivacaine

Procedure

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

Giorgio Veneziano

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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