<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796572</url>
  </required_header>
  <id_info>
    <org_study_id>18-001552</org_study_id>
    <nct_id>NCT03796572</nct_id>
  </id_info>
  <brief_title>Regional Blocks for Lateral Condyle Fractures</brief_title>
  <official_title>A Randomized Controlled Trial of Infraclavicular Nerve Blocks for Postoperative Pain Control in Operative Pediatric Lateral Condyle Fractures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the post-operative pain control in pediatric&#xD;
      patients with closed lateral condyle fractures who undergo open reduction and percutaneous&#xD;
      pinning. Patients will be randomized into one of two groups. Group 1 will receive an&#xD;
      infraclavicular nerve block to the affected extremity by a fellowship trained pediatric&#xD;
      anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of&#xD;
      Children's (OIC) standard preoperative protocol. Post-operative pain management will be the&#xD;
      same for both groups per standard protocol. Pain level will be assessed post-operatively&#xD;
      using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire&#xD;
      regarding their satisfaction with the surgery and pain control. Parents will also fill out a&#xD;
      medication log until the patient no longer requires pain medication. All patients in both&#xD;
      groups will receive standard oxycodone solution prescriptions post-operatively as per typical&#xD;
      protocol. The duration of participation in the study is approximately 1 week and requires 2&#xD;
      visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted&#xD;
      in hopes of developing comprehensive pain management protocols to reduce opioid consumption&#xD;
      after surgical fixations of displaced lateral condyle fractures if the study can show that&#xD;
      patients are more satisfied and require less opioid medication when receiving preoperative&#xD;
      regional anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of&#xD;
      infraclavicular regional blocks for postoperative pain control in patients following open&#xD;
      reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each&#xD;
      patient will be evaluated initially at OIC's pediatric urgent care center and placed in a&#xD;
      long arm splint with instructions to elevate the affected arm. Patients will not be&#xD;
      discharged with any prescriptions for narcotic pain medication and will be instructed to take&#xD;
      weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.&#xD;
&#xD;
      All patients age 4-12 with isolated closed Weiss classification type II and III (&gt;2mm&#xD;
      displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not&#xD;
      achieved with closed reduction and casting) will be approached for participation in the&#xD;
      study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at&#xD;
      home, insurance type) will be obtained through chart review on each included patient.&#xD;
&#xD;
      The exclusion criteria include open fractures, fractures with concomitant vascular or&#xD;
      neurologic deficit, pathologic fractures, those presenting with concomitant injuries,&#xD;
      swelling requiring post-operative hospitalization for monitoring, any known history of&#xD;
      allergies to ropivacaine or oxycodone, and patients with developmental delay that would&#xD;
      preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will&#xD;
      be obtained from all parents who wish to participate in the study, and assent will be&#xD;
      obtained from patients when possible. If parents refuse participation in the study, the&#xD;
      reason for refusal will be documented, and their child's care and post-operative protocol&#xD;
      will be consistent with typical protocol at OIC.&#xD;
&#xD;
      All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery&#xD;
      each patient will be randomized into one of two treatment groups. The group selected to&#xD;
      undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular&#xD;
      nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in&#xD;
      the operating room using standard sterile technique. For each block ropivacaine 0.5% will be&#xD;
      administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block&#xD;
      duration and volume of ropivacaine used will be recorded, as will any immediate complications&#xD;
      encountered (e.g. failed block). Participants randomized to the no regional anesthesia group&#xD;
      will not receive any additional anesthetic prior to surgery and will undergo OIC's standard&#xD;
      preoperative protocol. All patients in both groups will receive general anesthesia per&#xD;
      standard protocol. All patients will undergo open reduction and percutaneous pinning using&#xD;
      2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr.&#xD;
      Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter&#xD;
      and made non-weight bearing in that extremity. The patients will be transferred to OIC's&#xD;
      post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed&#xD;
      before discharge home. Nursing staff will record the amount of pain medication provided in&#xD;
      the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol.&#xD;
      Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed&#xD;
      will be given to all participants in both groups with instructions on medication&#xD;
      administration and how to fill out the home medication log as per typical OIC post-operative&#xD;
      protocol.&#xD;
&#xD;
      Post-operatively, the parents of each participant will be asked to use the Faces Pain&#xD;
      Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after&#xD;
      surgery. A research team member will call each participant's guardian at 24 and 48 hours&#xD;
      post-operatively to collect these responses. Parents will further be asked to complete the&#xD;
      modified Total Quality Pain Management Instrument (TQPM) regarding their level of&#xD;
      satisfaction with surgery and post-operative pain control. Parents will be asked to report&#xD;
      any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the&#xD;
      medications. Parents will also be asked about any side effects (e.g. swelling, redness,&#xD;
      hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be&#xD;
      utilized by the parents to record the type and amount of mediation given to each participant&#xD;
      and to record any associated side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 16, 2019</start_date>
  <completion_date type="Anticipated">March 7, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 7, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double-blinded randomized control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Randomized envelopes used to allocate treatment groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Wong-Baker FACES Pain Scale-Revised (FPSR)</measure>
    <time_frame>24 hours, 48 hours, and 1 week post-operatively</time_frame>
    <description>Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire</measure>
    <time_frame>1 week at first post-operative follow-up</time_frame>
    <description>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: &quot;What were you told about the hurt or pain?&quot;, &quot;How did the pain medicine make you feel?&quot;, &quot;How long did the hurt or pain last?&quot;, &quot;How much hurt or pain did you feel?&quot;, &quot;How happy were you with the pain?&quot;, and &quot;Tell us how we could get an A+ for taking the hurt or pain away.&quot; 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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain Medication Logs (Amount Taken)</measure>
    <time_frame>Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.</time_frame>
    <description>Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain Medication Logs (Side Effects)</measure>
    <time_frame>Immediately after surgery. Until the patient returns to first post-operative visit, 7-10 days post-operatively, assess up to 10 days.</time_frame>
    <description>Self report take home medications logs recording associated side effects of medication taken.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Fractures, Closed</condition>
  <condition>Humeral Fractures</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Infraclavicular Regional Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Puncture Wound</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This group is given the same puncture wound and dressing given to the experimental group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine</description>
    <arm_group_label>Infraclavicular Regional Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Puncture Wound and Dressing</intervention_name>
    <description>No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture</description>
    <arm_group_label>Puncture Wound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Isolated lateral condyle humerus fracture&#xD;
&#xD;
          -  Closed lateral condyle humerus fracture&#xD;
&#xD;
          -  Weiss classification type II and III (&gt;2mm displacement) lateral condyle fractures&#xD;
&#xD;
          -  Fractures treated with open reduction percutaneous pinning requiring fixation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open fractures&#xD;
&#xD;
          -  Fractures with concomitant vascular or neurologic deficit&#xD;
&#xD;
          -  Pathologic fractures&#xD;
&#xD;
          -  Those presenting with concomitant injuries&#xD;
&#xD;
          -  Swelling requiring post-operative hospitalization for monitoring&#xD;
&#xD;
          -  Any known history of allergies to ropivacaine or oxycodone&#xD;
&#xD;
          -  Patients with developmental delay that would preclude participation in the visual&#xD;
             analog Faces Pain Scale-Revised&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Samantha C Bauer, MS</last_name>
    <phone>2137426537</phone>
    <phone_ext>6537</phone_ext>
    <email>SBauer@mednet.ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sierra M Pinal, BS</last_name>
    <phone>2137421057</phone>
    <phone_ext>1057</phone_ext>
    <email>spinal@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Orthopaedic Institute for Children</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauricio Silva, MD</last_name>
      <phone>213-742-1369</phone>
      <email>msilva@mednet.ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Samantha C Bauer, MS</last_name>
      <phone>2137426537</phone>
      <phone_ext>6537</phone_ext>
      <email>SBauer@mednet.ucla.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Mauricio Silva, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Mauricio Silva</investigator_full_name>
    <investigator_title>Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>lateral condyle</keyword>
  <keyword>infraclavicular</keyword>
  <keyword>regional block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Humeral Fractures</mesh_term>
    <mesh_term>Fractures, Closed</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796572
org study id: 18-001552
nct id: NCT03796572
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of
      infraclavicular regional blocks for postoperative pain control in patients following open
      reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each
      patient will be evaluated initially at OIC's pediatric urgent care center and placed in a
      long arm splint with instructions to elevate the affected arm. Patients will not be
      discharged with any prescriptions for narcotic pain medication and will be instructed to take
      weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.

      All patients age 4-12 with isolated closed Weiss classification type II and III (>2mm
      displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not
      achieved with closed reduction and casting) will be approached for participation in the
      study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at
      home, insurance type) will be obtained through chart review on each included patient.

      The exclusion criteria include 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, and patients with developmental delay that would
      preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will
      be obtained from all parents who wish to participate in the study, and assent will be
      obtained from patients when possible. If parents refuse participation in the study, the
      reason for refusal will be documented, and their child's care and post-operative protocol
      will be consistent with typical protocol at OIC.

      All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery
      each patient will be randomized into one of two treatment groups. The group selected to
      undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular
      nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in
      the operating room using standard sterile technique. For each block ropivacaine 0.5% will be
      administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block
      duration and volume of ropivacaine used will be recorded, as will any immediate complications
      encountered (e.g. failed block). Participants randomized to the no regional anesthesia group
      will not receive any additional anesthetic prior to surgery and will undergo OIC's standard
      preoperative protocol. All patients in both groups will receive general anesthesia per
      standard protocol. All patients will undergo open reduction and percutaneous pinning using
      2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr.
      Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter
      and made non-weight bearing in that extremity. The patients will be transferred to OIC's
      post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed
      before discharge home. Nursing staff will record the amount of pain medication provided in
      the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol.
      Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed
      will be given to all participants in both groups with instructions on medication
      administration and how to fill out the home medication log as per typical OIC post-operative
      protocol.

      Post-operatively, the parents of each participant will be asked to use the Faces Pain
      Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after
      surgery. A research team member will call each participant's guardian at 24 and 48 hours
      post-operatively to collect these responses. Parents will further be asked to complete the
      modified Total Quality Pain Management Instrument (TQPM) regarding their level of
      satisfaction with surgery and post-operative pain control. Parents will be asked to report
      any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the
      medications. Parents will also be asked about any side effects (e.g. swelling, redness,
      hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be
      utilized by the parents to record the type and amount of mediation given to each participant
      and to record any associated side effects.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blinded randomized control trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Randomized envelopes used to allocate treatment groups.
measure: Change in Wong-Baker FACES Pain Scale-Revised (FPSR)
time frame: 24 hours, 48 hours, and 1 week post-operatively
description: Self reported measure of pain on scale ranging from 0 to 10. 0 (best) equals no pain and 10 (worst) equals worse pain imaginable.
measure: Total Quality Pain Management (TQPM) Instrument: 30 question questionnaire
time frame: 1 week at first post-operative follow-up
description: 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.
measure: 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.
description: Self report take home medications logs recording time, type, and dosage of medication to record total amount of medication (mg) taken by patient.
measure: 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.
description: Self report take home medications logs recording associated side effects of medication taken.
arm group label: Infraclavicular Regional Block
arm group type: Experimental
description: This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.
arm group label: Puncture Wound
arm group type: Sham Comparator
description: This group is given the same puncture wound and dressing given to the experimental group.
intervention type: Drug
intervention name: Ropivacaine
description: Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
arm group label: Infraclavicular Regional Block
intervention type: Other
intervention name: Puncture Wound and Dressing
description: No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
arm group label: Puncture Wound
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samantha C Bauer, MS
phone: 2137426537
phone ext: 6537
email: SBauer@mednet.ucla.edu
last name: Sierra M Pinal, BS
phone: 2137421057
phone ext: 1057
email: spinal@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Mauricio Silva
investigator title: Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator
mesh term: Fractures, Bone
mesh term: Humeral Fractures
mesh term: Fractures, Closed
mesh term: Ropivacaine
sharing ipd: No