Regional Blocks for Lateral Condyle Fractures

NCT03796572 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 18-001552
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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; Pain; Humeral Fractures

Keywords

lateral condyle; infraclavicular; regional block

Outcome Measures

Primary Outcomes (1)

• Change in Wong-Baker FACES Pain Scale-Revised (FPSR)

  Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.

  24 hours, 48 hours, and 1 week post-operatively

Secondary Outcomes (1)

• Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire

  1 week at first post-operative follow-up

Other Outcomes (2)

• Pain Medication Logs (Amount Taken)

  Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

• Pain Medication Logs (Side Effects)

  Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.

Study Arms (2)

Infraclavicular Regional Block

EXPERIMENTAL

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

Drug: Ropivacaine

Puncture Wound

SHAM COMPARATOR

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

Other: Puncture Wound and Dressing

Interventions

Ropivacaine DRUG

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

Infraclavicular Regional Block

Puncture Wound and Dressing OTHER

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

Puncture Wound

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Closed; Humeral Fractures; Pain

Interventions

Ropivacaine; Punctures; Bandages

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Arm Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics; Surgical Procedures, Operative; Equipment and Supplies

Central Study Contacts

Lindsey Han, BA

CONTACT

(213) 742-1074; LLHan@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized envelopes used to allocate treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator

Model Details: Double-blinded randomized control trial

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: September 16, 2019
• Primary Completion (Estimated): January 7, 2027
• Study Completion (Estimated): March 7, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)