Regional Blocks for Lateral Condyle Fractures

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT03796572
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Fractures, Closed
  • Humeral Fractures
  • Pain

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Ropivacaine — DRUG
    Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
  • Puncture Wound and Dressing — OTHER
    No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture

Study Details

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.

Key Dates

Start date
Sep 16, 2019
Status verified
Apr 2026
Primary completion
Jan 7, 2027
Completion
Mar 7, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Orthopaedic Institute for ChildrenLos AngelesCalifornia90007
Mauricio Silva, MD
[email protected]
(213) 742-1369
Samantha C Bauer, MS
[email protected]
2137426537
Mauricio Silva, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Orthopaedic Institute for Children· Los Angeles, CA

Related Studies