<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/NCT02236130</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0027</org_study_id>
    <nct_id>NCT02236130</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Blocks in Pediatric Orthopedic Patients</brief_title>
  <official_title>Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Context:&#xD;
&#xD;
      Single shot peripheral nerve blocks have limited duration of action depending on the local&#xD;
      anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need&#xD;
      oral analgesics at home once the block wears off to control the pain.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
      To determine if peripheral nerve blocks have any advantage in terms of decreasing oral&#xD;
      analgesic requirements in the post operative period even after the effects of the block have&#xD;
      worn off&#xD;
&#xD;
      Secondary Objective&#xD;
&#xD;
      To determine if inclusion of single shot regional technique improves patient/family&#xD;
      satisfaction with post operative pain management .&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Prospective randomized single blinded study.&#xD;
&#xD;
      Inclusion Criteria&#xD;
&#xD;
        -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic&#xD;
           surgery with moderate to severe postoperative pain.&#xD;
&#xD;
        -  Surgery of moderate duration (&lt;2hr)&#xD;
&#xD;
        -  Surgery associated with minimal blood loss or fluid shifts (&lt;10% total blood volume)&#xD;
&#xD;
        -  American Society of Anesthesiologists (ASA) classification 1 or 2&#xD;
&#xD;
        -  Parents able to understand follow up instructions and are able to reach at home by phone&#xD;
&#xD;
      Exclusion Criteria&#xD;
&#xD;
        -  Known allergy to local anesthetics&#xD;
&#xD;
        -  Preexisting neuropathy with sensory or motor deficits&#xD;
&#xD;
        -  Skin infection at site of needle placement&#xD;
&#xD;
        -  Parents refusal for peripheral nerve blocks&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral&#xD;
      orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled&#xD;
      in the study. Written informed consent will be obtained from the parents or legal guardian&#xD;
      and assent will be obtained from patients when possible.&#xD;
&#xD;
      Once enrolled in the study, patients will be randomly assigned to one of two groups General&#xD;
      anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA&#xD;
      group). Once the patients are brought to the operating room standard ASA monitors will be&#xD;
      applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral&#xD;
      intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg&#xD;
      will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in&#xD;
      GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA&#xD;
      group will receive a peripheral nerve block appropriate for the procedure after induction of&#xD;
      general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve&#xD;
      block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G&#xD;
      stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg&#xD;
      will be used for the block.&#xD;
&#xD;
      Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar&#xD;
      concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV&#xD;
      every 5 min as needed titrated to HR and BP within 10% change from baseline.&#xD;
&#xD;
      Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the&#xD;
      recovery room (PACU) as needed for pain ( Visual Analog score -VAS score &gt;4). Total morphine&#xD;
      consumption, length of recovery room stay and side effects such as nausea or vomiting will be&#xD;
      recorded in the PACU.&#xD;
&#xD;
      The patients in the study will be given the following&#xD;
&#xD;
        1. A prescription for oral analgesics (lortab: hydrocodone 5mg with acetaminophen 325mg).&#xD;
&#xD;
        2. A handout about the nerve block and post op care (for patients in RA group)&#xD;
&#xD;
        3. A handout depicting the visual analog scale&#xD;
&#xD;
        4. Data sheet with date, time, pain scale and pain meds , satisfaction scale, documentation&#xD;
           of side effects along with a stamped return envelope.&#xD;
&#xD;
      The parents will be educated about assessing pain and visual analog scale score. The parents&#xD;
      will be instructed to give one or two pills depending on the weight (one pill for weight&#xD;
      &lt;50kg and 2 pills for weight &gt;50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).&#xD;
&#xD;
      The patients will be followed by phone by research nurse blinded to the group on&#xD;
      postoperative day 2 and day 8. They will be asked about the total use of analgesics at the&#xD;
      end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of&#xD;
      other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and&#xD;
      prolonged numbness or motor block will also be collected.&#xD;
&#xD;
      The parents will also be requested to return the data sheet in the stamped return envelope to&#xD;
      the research team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor response rate on follow up of patients&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Hydrocodone Dose (mg/kg)</measure>
    <time_frame>day 2 and day 8 after the surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient/Family Satisfaction With Pain Management</measure>
    <time_frame>one week after the surgery</time_frame>
    <description>Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Pediatric Extremity Fracture</condition>
  <condition>Pediatric Extremity Soft Tissue Injury</condition>
  <arm_group>
    <arm_group_label>General</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General Anesthesia only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>General Anesthesia combined with regional block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional block</intervention_name>
    <description>Single shot peripheral nerve block</description>
    <arm_group_label>Regional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General Anesthesia</intervention_name>
    <description>General Anesthesia with O2/N2O/Sevoflurane</description>
    <arm_group_label>General</arm_group_label>
    <arm_group_label>Regional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local Anesthetic Ropivacaine</intervention_name>
    <description>0.5% Ropivacaine</description>
    <arm_group_label>Regional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Opioids Morphine</intervention_name>
    <description>Morphine</description>
    <arm_group_label>General</arm_group_label>
    <arm_group_label>Regional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral pain medication Acetaminophen with Hydrocodone</intervention_name>
    <description>Acetaminophen with Hydrocodone</description>
    <arm_group_label>General</arm_group_label>
    <arm_group_label>Regional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic&#xD;
             surgery with moderate to severe postoperative pain.&#xD;
&#xD;
          -  Surgery of moderate duration (&lt;2hr)&#xD;
&#xD;
          -  Surgery associated with minimal blood loss or fluid shifts (&lt;10% total blood volume)&#xD;
&#xD;
          -  ASA classification 1 or 2&#xD;
&#xD;
          -  Parents able to understand follow up instructions and are able to reach at home by&#xD;
             phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to local anesthetics&#xD;
&#xD;
          -  Preexisting neuropathy with sensory or motor deficits&#xD;
&#xD;
          -  Skin infection at site of needle placement&#xD;
&#xD;
          -  Parents refusal for peripheral nerve blocks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>madhankumar sathyamoorthy, MBBS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.</citation>
    <PMID>22786464</PMID>
  </reference>
  <reference>
    <citation>Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.</citation>
    <PMID>18498436</PMID>
  </reference>
  <reference>
    <citation>Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.</citation>
    <PMID>24330523</PMID>
  </reference>
  <reference>
    <citation>Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.</citation>
    <PMID>24407716</PMID>
  </reference>
  <reference>
    <citation>Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.</citation>
    <PMID>21895855</PMID>
  </reference>
  <reference>
    <citation>Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27.</citation>
    <PMID>21951324</PMID>
  </reference>
  <reference>
    <citation>Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.</citation>
    <PMID>21199114</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <results_first_submitted>December 30, 2015</results_first_submitted>
  <results_first_submitted_qc>December 30, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 3, 2016</results_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Madhankumar Sathyamoorthy</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pediatric regional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Soft Tissue Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Hydrocodone</mesh_term>
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>General</title>
          <description>General Anesthesia only&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
        <group group_id="P2">
          <title>Regional</title>
          <description>General Anesthesia combined with regional block&#xD;
Regional block: Single shot peripheral nerve block&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Local Anesthetic Ropivacaine: 0.5% Ropivacaine&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>General</title>
          <description>General Anesthesia only&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
        <group group_id="B2">
          <title>Regional</title>
          <description>General Anesthesia combined with regional block&#xD;
Regional block: Single shot peripheral nerve block&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Local Anesthetic Ropivacaine: 0.5% Ropivacaine&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.55" lower_limit="6" upper_limit="15"/>
                    <measurement group_id="B2" value="11.41" lower_limit="6" upper_limit="15"/>
                    <measurement group_id="B3" value="11.02" lower_limit="6" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Hydrocodone Dose (mg/kg)</title>
        <time_frame>day 2 and day 8 after the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>General</title>
            <description>General Anesthesia only&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
          </group>
          <group group_id="O2">
            <title>Regional</title>
            <description>General Anesthesia combined with regional block&#xD;
Regional block: Single shot peripheral nerve block&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Local Anesthetic Ropivacaine: 0.5% Ropivacaine&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
          </group>
        </group_list>
        <measure>
          <title>Total Hydrocodone Dose (mg/kg)</title>
          <units>mg/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2 Total hydrocodone use in mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="0.67"/>
                    <measurement group_id="O2" value="1.36" spread="0.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 Total hydrocodone use in mg/kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="0.82"/>
                    <measurement group_id="O2" value="2.15" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient/Family Satisfaction With Pain Management</title>
        <description>Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.</description>
        <time_frame>one week after the surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>General</title>
            <description>General Anesthesia only&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
          </group>
          <group group_id="O2">
            <title>Regional</title>
            <description>General Anesthesia combined with regional block&#xD;
Regional block: Single shot peripheral nerve block&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Local Anesthetic Ropivacaine: 0.5% Ropivacaine&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
          </group>
        </group_list>
        <measure>
          <title>Patient/Family Satisfaction With Pain Management</title>
          <description>Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>General</title>
          <description>General Anesthesia only&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
        <group group_id="E2">
          <title>Regional</title>
          <description>General Anesthesia combined with regional block&#xD;
Regional block: Single shot peripheral nerve block&#xD;
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane&#xD;
Local Anesthetic Ropivacaine: 0.5% Ropivacaine&#xD;
Opioids Morphine: Morphine&#xD;
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Madhankumar Sathyamoorthy</name_or_title>
      <organization>University of Mississippi Medical Center</organization>
      <phone>6018157066</phone>
      <email>msathyamoorthy@umc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02236130
org study id: 2014-0027
nct id: NCT02236130
lead sponsor: 
has dmc: Yes
Context:

      Single shot peripheral nerve blocks have limited duration of action depending on the local
      anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need
      oral analgesics at home once the block wears off to control the pain.

      Objectives:

      Primary Objective

      To determine if peripheral nerve blocks have any advantage in terms of decreasing oral
      analgesic requirements in the post operative period even after the effects of the block have
      worn off

      Secondary Objective

      To determine if inclusion of single shot regional technique improves patient/family
      satisfaction with post operative pain management .

      Study Design:

      Prospective randomized single blinded study.

      Inclusion Criteria

        -  Children aged between 6 yr and 17yr scheduled for ambulatory peripheral orthopedic
           surgery with moderate to severe postoperative pain.

        -  Surgery of moderate duration (<2hr)

        -  Surgery associated with minimal blood loss or fluid shifts (<10% total blood volume)

        -  American Society of Anesthesiologists (ASA) classification 1 or 2

        -  Parents able to understand follow up instructions and are able to reach at home by phone

      Exclusion Criteria

        -  Known allergy to local anesthetics

        -  Preexisting neuropathy with sensory or motor deficits

        -  Skin infection at site of needle placement

        -  Parents refusal for peripheral nerve blocks
80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral
      orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled
      in the study. Written informed consent will be obtained from the parents or legal guardian
      and assent will be obtained from patients when possible.

      Once enrolled in the study, patients will be randomly assigned to one of two groups General
      anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA
      group). Once the patients are brought to the operating room standard ASA monitors will be
      applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral
      intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg
      will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in
      GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA
      group will receive a peripheral nerve block appropriate for the procedure after induction of
      general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve
      block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G
      stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg
      will be used for the block.

      Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar
      concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV
      every 5 min as needed titrated to HR and BP within 10% change from baseline.

      Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the
      recovery room (PACU) as needed for pain ( Visual Analog score -VAS score >4). Total morphine
      consumption, length of recovery room stay and side effects such as nausea or vomiting will be
      recorded in the PACU.

      The patients in the study will be given the following

        1. A prescription for oral analgesics (lortab: hydrocodone 5mg with acetaminophen 325mg).

        2. A handout about the nerve block and post op care (for patients in RA group)

        3. A handout depicting the visual analog scale

        4. Data sheet with date, time, pain scale and pain meds , satisfaction scale, documentation
           of side effects along with a stamped return envelope.

      The parents will be educated about assessing pain and visual analog scale score. The parents
      will be instructed to give one or two pills depending on the weight (one pill for weight
      <50kg and 2 pills for weight >50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).

      The patients will be followed by phone by research nurse blinded to the group on
      postoperative day 2 and day 8. They will be asked about the total use of analgesics at the
      end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of
      other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and
      prolonged numbness or motor block will also be collected.

      The parents will also be requested to return the data sheet in the stamped return envelope to
      the research team.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Total Hydrocodone Dose (mg/kg)
time frame: day 2 and day 8 after the surgery
measure: Patient/Family Satisfaction With Pain Management
time frame: one week after the surgery
description: Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.
arm group label: General
arm group type: Active Comparator
description: General Anesthesia only
arm group label: Regional
arm group type: Experimental
description: General Anesthesia combined with regional block
intervention type: Procedure
intervention name: Regional block
description: Single shot peripheral nerve block
arm group label: Regional
intervention type: Procedure
intervention name: General Anesthesia
description: General Anesthesia with O2/N2O/Sevoflurane
arm group label: General
arm group label: Regional
intervention type: Drug
intervention name: Local Anesthetic Ropivacaine
description: 0.5% Ropivacaine
arm group label: Regional
intervention type: Drug
intervention name: Opioids Morphine
description: Morphine
arm group label: General
arm group label: Regional
intervention type: Drug
intervention name: Oral pain medication Acetaminophen with Hydrocodone
description: Acetaminophen with Hydrocodone
arm group label: General
arm group label: Regional
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: madhankumar sathyamoorthy, MBBS, MS
role: Principal Investigator
affiliation: University of Mississippi Medical Center
facility: 
country: United States
citation: Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PMID: 22786464
citation: Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21.
PMID: 18498436
citation: Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11.
PMID: 24330523
citation: Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.
PMID: 24407716
citation: Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.
PMID: 21895855
citation: Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27.
PMID: 21951324
citation: Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x.
PMID: 21199114
responsible party type: Principal Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Madhankumar Sathyamoorthy
investigator title: Assistant Professor
mesh term: Soft Tissue Injuries
mesh term: Acetaminophen
mesh term: Morphine
mesh term: Hydrocodone
mesh term: Analgesics
mesh term: Anesthetics
mesh term: Ropivacaine
mesh term: Anesthetics, Local
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 