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NCT03796572 · ClinicalTrials.gov registry record · Phase 4
Regional Blocks for Lateral Condyle Fractures
A Phase 4 study of Pain and Fractures, Closed, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT03796572: Recruiting Phase 4 study of Pain and Fractures, Closed, sponsored by University of California, Los Angeles.
NCT03796572 is a Phase 4 study of Pain and Fractures, Closed that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 90 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03796572, a Phase 4 study of Pain and Fractures, Closed, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.
Conditions Studied
Interventions
- DRUG Ropivacaine
- OTHER Puncture Wound and Dressing
Study Locations (1)
California
- Orthopaedic Institute for Children - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2027-03-07 |
| Phase | Phase 4 |
What NCT03796572 shows while recruiting
NCT03796572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Ropivacaine is the first listed.
NCT03796572 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03796572 about?
NCT03796572 is a clinical study titled "Regional Blocks for Lateral Condyle Fractures". 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 ...
What is the current status of trial NCT03796572?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2019-09-16. Estimated completion is 2027-03-07.
What conditions does trial NCT03796572 study?
This clinical trial studies the following conditions: Pain, Fractures, Closed, Humeral Fractures.
What interventions are being tested in trial NCT03796572?
The interventions under investigation include: Ropivacaine (DRUG), Puncture Wound and Dressing (OTHER).
Who is sponsoring clinical trial NCT03796572?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03796572 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03796572's enrollment target sits among peer trials
90 182nd of 374 higher than 192 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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