Pain control for children with lateral condyle fractures
A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures
This study tests if a special pain relief method called an infraclavicular nerve block can help children with arm fractures feel less pain after surgery compared to regular care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03796572 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of infraclavicular nerve blocks for managing post-operative pain in pediatric patients with closed lateral condyle fractures undergoing surgery. Participants will be randomly assigned to receive either the nerve block or standard preoperative care. Pain levels will be assessed post-surgery using the Wong-Baker FACES scale, and parents will provide feedback on their child's pain management and satisfaction. The study aims to determine if the nerve block improves pain control compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-12 with isolated closed lateral condyle fractures classified as Weiss type II or III requiring surgical fixation.
Not a fit: Patients with open fractures, concomitant injuries, or developmental delays that affect pain assessment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management for children undergoing surgery for lateral condyle fractures.
How similar studies have performed: Other studies have shown promising results with regional blocks for pain management in pediatric populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Orthopaedic Institute for Children — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Lindsey Han, BA
- Email: LLHan@mednet.ucla.edu
- Phone: (213) 742-1074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.