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Regional Anesthesia for Broken Arm

Phase 4
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fractures treated with open reduction percutaneous pinning requiring fixation
Isolated lateral condyle humerus fracture
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.
Awards & highlights

Study Summary

This trial is investigating whether preoperative regional anesthesia can reduce postoperative pain and the need for opioids in children with a certain type of broken bone.

Who is the study for?
This trial is for children with a specific type of broken arm (isolated lateral condyle humerus fracture) that needs surgery to fix it. They must not have other injuries, allergies to ropivacaine or oxycodone, open fractures, swelling needing hospital stays after surgery, or conditions affecting their ability to rate pain using facial expressions.Check my eligibility
What is being tested?
The study compares two ways to manage pain after arm fracture surgery in kids. One group gets a nerve block before surgery; the other follows standard care. Both get oxycodone afterwards. Pain and satisfaction are checked using scales and questionnaires over about one week.See study design
What are the potential side effects?
Possible side effects include reactions at the puncture site from the nerve block or dressing application and any known side effects of ropivacaine like numbness or weakness in the area where it's given.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to fix a broken bone with pins.
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I have a fracture in the outer part of my elbow bone.
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My elbow fracture is classified as a type II or III lateral condyle with more than 2mm displacement.
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I have a specific type of elbow fracture.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after surgery. until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Wong-Baker FACES Pain Scale-Revised (FPSR)
Secondary outcome measures
Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
Other outcome measures
Pain Medication Logs (Amount Taken)
Pain Medication Logs (Side Effects)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Infraclavicular Regional BlockExperimental Treatment1 Intervention
This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.
Group II: Puncture WoundPlacebo Group1 Intervention
This group is given the same puncture wound and dressing given to the experimental group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
FDA approved

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,112 Total Patients Enrolled
9 Trials studying Pain
1,312 Patients Enrolled for Pain

Media Library

Ropivacaine Clinical Trial Eligibility Overview. Trial Name: NCT03796572 — Phase 4
Pain Research Study Groups: Infraclavicular Regional Block, Puncture Wound
Pain Clinical Trial 2023: Ropivacaine Highlights & Side Effects. Trial Name: NCT03796572 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Ropivacaine pose any substantial risks for individuals taking it medicinally?

"As a Phase 4 trial, this medication has already been approved and thus received an extensive safety score of 3."

Answered by AI

What criteria must be met in order for individuals to partake in this medical experiment?

"The standards for this clinical trial necessitate that applicants have experienced humeral fractures and be between 4 to 12 years of age. At the moment, 90 participants are needed for enrolment."

Answered by AI

What medical ailment does Ropivacaine typically alleviate?

"Ropivacaine is a popular anesthetic used to manage pain related to surgical procedures, parturition, and post-procedural discomfort."

Answered by AI

Are volunteers presently being recruited for this clinical experiment?

"Clinicaltrials.gov indicates that this experiment is presently enrolling patients, with the initial postdating back to September 16th 2019 and the latest update from April 26th 2021."

Answered by AI

Does this clinical trial extend to adults beyond the age of 25?

"This clinical trial is designed for 4 to 12 year olds. Those below 18 and those above 65 have 149 and 581 trials respectively available to them."

Answered by AI

Are there any limitations on the number of participants for this research?

"Affirmative, the information published on clinicaltrials.gov indicates that this trial is in progress and actively seeking participants. The listing was first posted on September 16th 2019 and updated as recently as April 26th 2021; recruiting for a total of 90 individuals from 1 medical centre."

Answered by AI

Who else is applying?

What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
Orthopaedic Institute for Children
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Regional Blocks for Lateral Condyle Fractures
Mauricio Silva 2019. "Regional Blocks for Lateral Condyle Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03796572.
~16 spots leftby Apr 2025
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