NCT03796572 · University of California, Los Angeles
Regional Blocks for Lateral Condyle Fractures
What this study is about
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 randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Ropivacaine
Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
OTHER
Puncture Wound and Dressing
No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
Primary outcome measures
Change in Wong-Baker FACES Pain Scale-Revised (FPSR)
Time frame: 24 hours, 48 hours, and 1 week post-operatively
Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Isolated lateral condyle humerus fracture
- Closed lateral condyle humerus fracture
- Weiss classification type II and III (\>2mm displacement) lateral condyle fractures
- Fractures treated with open reduction percutaneous pinning requiring fixation
Exclusion criteria
- Open fractures
- Fractures with concomitant vascular or neurologic deficit
- Pathologic fractures
- Those presenting with concomitant injuries
- Swelling requiring post-operative hospitalization for monitoring
- Any known history of allergies to ropivacaine or oxycodone
- Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations