Regional Blocks for Lateral Condyle Fractures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity of California, Los Angeles
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Open fractures
Fractures with concomitant vascular or neurologic deficit
Pathologic fractures
Those presenting with concomitant injuries
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine
DrugRegional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
Puncture Wound and Dressing
Other interventionNo regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Infraclavicular Regional BlockExperimental treatment 1 intervention
Group B: Puncture WoundSham comparator 1 intervention
Trial outcomes
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.
Time frame
24 hours, 48 hours, and 1 week post-operativelySecondary outcomes
1
Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
30 question questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions. Questions are partitioned into the following categories: "What were you told about the hurt or pain?", "How did the pain medicine make you feel?", "How long did the hurt or pain last?", "How much hurt or pain did you feel?", "How happy were you with the pain?", and "Tell us how we could get an A+ for taking the hurt or pain away." Specific questions were aimed at gaining information on the following topics: post-operative pain management including domains in pain experience, pain relief, adverse affects, and future analgesic uses. The majority of the questions are binary (yes or no) and there are a few questions that include mild (best), moderate, and severe (worst) option. There is no numerical output or subscales; every question is evaluated independently and not combined for summary scores.
Time frame
1 week at first post-operative follow-upOther outcomes
1
Pain Medication Logs (Amount Taken)
Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient.
Time frame
Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.2
Pain Medication Logs (Side Effects)
Self report take home medications logs recording associated side effects of medication taken.
Time frame
Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.Sponsors and contacts
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Source ClinicalTrials.gov