NCT03796572 Regional Blocks for Lateral Condyle Fractures
| NCT ID | NCT03796572 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Los Angeles |
| Condition | Fractures, Closed |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-09-16 |
| Primary Completion | 2027-01-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2019-09-16 with a primary completion date of 2027-01-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03796572 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Fractures, Closed. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03796572 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03796572 currently recruiting?
Yes, NCT03796572 is actively recruiting participants. Contact the research team at LLHan@mednet.ucla.edu for enrollment information.
Where is the NCT03796572 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT03796572 clinical trial?
NCT03796572 is sponsored by University of California, Los Angeles. The trial plans to enroll 90 participants.