Recruiting

Regional Blocks

Sponsor:

UCLA

Code:

NCT03796572

Conditions

Fractures, Closed

Humeral Fractures

Pain

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Interventions

Ropivacaine

Puncture Wound and Dressing

Study Details

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.

Conditions

Fractures, Closed

Humeral Fractures

Pain

Study ID

NCT03796572

Start date

Sep 16, 2019

Status verified date

Apr, 2026

Completion date

Mar 7, 2027

Anticipated

Primary completion date

Jan 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Infraclavicular Regional Block

This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.

sham comparator: Puncture Wound

This group is given the same puncture wound and dressing given to the experimental group.

Interventions

Ropivacaine

Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine

Puncture Wound and Dressing

No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture

Primary outcome measure

  • Change in Wong-Baker FACES Pain Scale-Revised (FPSR) [ Time Frame: 24 hours, 48 hours, and 1 week post-operatively ]

Central Contacts and Locations

Central contacts

Locations

Orthopaedic Institute for Children

Recruiting

Los Angeles, California, United States, 90007

Contacts

Principal Investigator:

Mauricio Silva, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • lateral condyle
  • infraclavicular
  • regional block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-05.