A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures

Who is this study for? Pediatric patients with closed lateral condyle fractures undergoing open reduction and percutaneous pinning
What treatments are being studied? Ropivacaine
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Orthopaedic Institute for Children
RECRUITING
Los Angeles
Contact Information
Primary
Johanthan You, BS
JohnathanYou@mednet.ucla.edu
(213) 742-1074
Time Frame
Start Date: 2019-09-16
Estimated Completion Date: 2027-03-07
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov