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Regional Blocks for Lateral Condyle Fractures

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ClinicalTrials.gov Identifier: NCT03796572
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Mauricio Silva, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Fractures, Closed Humeral Fractures Pain Drug: Ropivacaine Other: Puncture Wound and Dressing Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized control trial
Masking: Double (Participant, Investigator)
Masking Description: Randomized envelopes used to allocate treatment groups.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : January 7, 2024
Estimated Study Completion Date : March 7, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ropivacaine
Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine

Sham Comparator: Puncture Wound
This group is given the same puncture wound and dressing given to the experimental group.
Other: Puncture Wound and Dressing
No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture




Primary Outcome Measures :
  1. Change in Wong-Baker FACES Pain Scale-Revised (FPSR) [ Time Frame: 24 hours, 48 hours, and 1 week post-operatively ]
    Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.


Secondary Outcome Measures :
  1. Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire [ Time Frame: 1 week at first post-operative follow-up ]
    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.


Other Outcome Measures:
  1. Pain Medication Logs (Amount 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. ]
    Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient.

  2. Pain Medication Logs (Side Effects) [ Time Frame: Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days. ]
    Self report take home medications logs recording associated side effects of medication taken.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796572


Contacts
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Contact: Samantha C Bauer, MS 2137426537 ext 6537 SBauer@mednet.ucla.edu
Contact: Sierra M Pinal, BS 2137421057 ext 1057 spinal@mednet.ucla.edu

Locations
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United States, California
Orthopaedic Institute for Children Recruiting
Los Angeles, California, United States, 90007
Contact: Mauricio Silva, MD    213-742-1369    msilva@mednet.ucla.edu   
Contact: Samantha C Bauer, MS    2137426537 ext 6537    SBauer@mednet.ucla.edu   
Principal Investigator: Mauricio Silva, MD         
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Mauricio Silva, Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03796572    
Other Study ID Numbers: 18-001552
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Mauricio Silva, University of California, Los Angeles:
lateral condyle
infraclavicular
regional block
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Fractures, Closed
Wounds and Injuries
Arm Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents