Summary

Eligibility
for people ages 4-12 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Mauricio Silva (ucla)

Description

Summary

The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children's (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.

Official Title

A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures

Details

Keywords

Fractures, Closed, Humeral Fractures, Pain, lateral condyle, infraclavicular, regional block, Bone Fractures, Closed Fractures, Ropivacaine, Puncture Wound and Dressing, Infraclavicular Regional Block, Puncture Wound

Eligibility

Location

  • Orthopaedic Institute for Children accepting new patients
    Los Angeles California 90007 United States

Lead Scientist at University of California Health

  • Mauricio Silva (ucla)
    HS Clinical Professor, Orthopaedic Surgery, Medicine. Authored (or co-authored) 38 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT03796572
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated