<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/NCT01696188</url>
  </required_header>
  <id_info>
    <org_study_id>12D.328</org_study_id>
    <nct_id>NCT01696188</nct_id>
  </id_info>
  <brief_title>A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.</brief_title>
  <official_title>Comparison of In-Plane vs. Out-of-Plane Ultrasound-Guided Approach for Interscalene Nerve Catheters: a Prospective, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blinded, prospective study designed to compare two approaches&#xD;
      (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing&#xD;
      an interscalene nerve block and catheter for pain control after open shoulder surgery. Both&#xD;
      approaches have been used successfully but neither has been proven to be superior. Our&#xD;
      endpoints are pain scores, time for block placement, and catheter dislodgements. We&#xD;
      hypothesized that patients with the out-of-plane approach would have decreased pain and fewer&#xD;
      catheter dislodgements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interscalene nerve block is an effective method of analgesia for surgery of the upper&#xD;
      extremity. Perineural interscalene catheters offer the advantage of extended pain relief up&#xD;
      to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to&#xD;
      compare two approaches (posterior and anterolateral) to interscalene continuous nerve&#xD;
      catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total&#xD;
      shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction&#xD;
      internal fixation). Specifically, the objectives of this study are to compare measured pain&#xD;
      scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral&#xD;
      approach will produce lower pain scores, less opioid consumption, and fewer catheter&#xD;
      dislodgements.&#xD;
&#xD;
      All patients undergoing open shoulder surgery will be recruited and enrollment in the study&#xD;
      will not deviate from the current standard of care at Thomas Jefferson University Hospital.&#xD;
      All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional&#xD;
      anesthesia. Patient medical history will be obtained and blocks will be placed per usual&#xD;
      protocol. Block efficacy will be assessed by physical exam immediately after placement by the&#xD;
      anesthesiologist and another member of the research team. Operative details, including&#xD;
      medications given, will be recorded.&#xD;
&#xD;
      Patient pain scores and medications given in the PACU will be recorded. Supplementary&#xD;
      analgesics will be available. Pain scores, medications given, and sensory examinations will&#xD;
      be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the&#xD;
      study and at several interims before that.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale Pain Scores</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain was rated from 0 (no pain) to 10 (worst pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catheter Dislodgements</measure>
    <time_frame>24 hours</time_frame>
    <description>Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>48 hours</time_frame>
    <description>Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for Block Placement</measure>
    <time_frame>immediately post-procedure</time_frame>
    <description>Calculate the time to perform the nerve block procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>In-plane group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an interscalene catheter placed with in-plane approach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Out-of-plane group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an interscalene catheter with an out-of-plan approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>interscalene nerve catheter</intervention_name>
    <arm_group_label>In-plane group</arm_group_label>
    <arm_group_label>Out-of-plane group</arm_group_label>
    <other_name>Peripheral nerve catheter kit, B Braun (Bethlehem, PA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  speaks English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children,&#xD;
&#xD;
          -  neuropathy in operative arm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. doi: 10.1097/aap.0b013e31820d5ee6.</citation>
    <PMID>21425511</PMID>
  </reference>
  <reference>
    <citation>Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53.</citation>
    <PMID>19258990</PMID>
  </reference>
  <reference>
    <citation>Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7.</citation>
    <PMID>19258989</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <results_first_submitted>August 4, 2015</results_first_submitted>
  <results_first_submitted_qc>October 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 16, 2015</results_first_posted>
  <last_update_submitted>October 14, 2015</last_update_submitted>
  <last_update_submitted_qc>October 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interscalene</keyword>
  <keyword>nerve block</keyword>
  <keyword>nerve catheter</keyword>
  <keyword>in-plane</keyword>
  <keyword>out-of-plane</keyword>
  <keyword>anterolateral approach</keyword>
  <keyword>posterior approach</keyword>
  <keyword>shoulder surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>In-plane Group</title>
          <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
        </group>
        <group group_id="P2">
          <title>Out-of-plane Group</title>
          <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>In-plane Group</title>
          <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
        </group>
        <group group_id="B2">
          <title>Out-of-plane Group</title>
          <description>This group will receive an interscalene catheter with an out-of-plan approach.&#xD;
interscalene nerve catheter</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="40"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="82"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.1" spread="10.7"/>
                    <measurement group_id="B2" value="63.8" spread="12"/>
                    <measurement group_id="B3" value="65.2" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="25"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="40"/>
                  </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="40"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale Pain Scores</title>
        <description>Pain was rated from 0 (no pain) to 10 (worst pain imaginable)</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-plane Group</title>
            <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
          <group group_id="O2">
            <title>Out-of-plane Group</title>
            <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale Pain Scores</title>
          <description>Pain was rated from 0 (no pain) to 10 (worst pain imaginable)</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Catheter Dislodgements</title>
        <description>Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-plane Group</title>
            <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
          <group group_id="O2">
            <title>Out-of-plane Group</title>
            <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Catheter Dislodgements</title>
          <description>Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption</title>
        <description>Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV</description>
        <time_frame>48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-plane Group</title>
            <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
          <group group_id="O2">
            <title>Out-of-plane Group</title>
            <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption</title>
          <description>Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV</description>
          <units>mg IV morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="12.5" upper_limit="65.0"/>
                    <measurement group_id="O2" value="35.3" lower_limit="24.8" upper_limit="70.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time for Block Placement</title>
        <description>Calculate the time to perform the nerve block procedure.</description>
        <time_frame>immediately post-procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-plane Group</title>
            <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
          <group group_id="O2">
            <title>Out-of-plane Group</title>
            <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Time for Block Placement</title>
          <description>Calculate the time to perform the nerve block procedure.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296" lower_limit="255" upper_limit="337"/>
                    <measurement group_id="O2" value="257" lower_limit="238" upper_limit="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>In-plane Group</title>
          <description>This group will receive an interscalene catheter placed with in-plane approach.&#xD;
interscalene nerve catheter</description>
        </group>
        <group group_id="E2">
          <title>Out-of-plane Group</title>
          <description>This group will receive an interscalene catheter with an out-of-plane approach.&#xD;
interscalene nerve catheter</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Eric Schwenk</name_or_title>
      <organization>Sidney Kimmel Medical College at Thomas Jefferson University</organization>
      <phone>215-955-6161</phone>
      <email>Eric.Schwenk@jefferson.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/NCT01696188
org study id: 12D.328
nct id: NCT01696188
lead sponsor: 
has dmc: No
This is a randomized, double-blinded, prospective study designed to compare two approaches
      (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing
      an interscalene nerve block and catheter for pain control after open shoulder surgery. Both
      approaches have been used successfully but neither has been proven to be superior. Our
      endpoints are pain scores, time for block placement, and catheter dislodgements. We
      hypothesized that patients with the out-of-plane approach would have decreased pain and fewer
      catheter dislodgements.
Interscalene nerve block is an effective method of analgesia for surgery of the upper
      extremity. Perineural interscalene catheters offer the advantage of extended pain relief up
      to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to
      compare two approaches (posterior and anterolateral) to interscalene continuous nerve
      catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total
      shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction
      internal fixation). Specifically, the objectives of this study are to compare measured pain
      scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral
      approach will produce lower pain scores, less opioid consumption, and fewer catheter
      dislodgements.

      All patients undergoing open shoulder surgery will be recruited and enrollment in the study
      will not deviate from the current standard of care at Thomas Jefferson University Hospital.
      All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional
      anesthesia. Patient medical history will be obtained and blocks will be placed per usual
      protocol. Block efficacy will be assessed by physical exam immediately after placement by the
      anesthesiologist and another member of the research team. Operative details, including
      medications given, will be recorded.

      Patient pain scores and medications given in the PACU will be recorded. Supplementary
      analgesics will be available. Pain scores, medications given, and sensory examinations will
      be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the
      study and at several interims before that.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Visual Analog Scale Pain Scores
time frame: 24 hours
description: Pain was rated from 0 (no pain) to 10 (worst pain imaginable)
measure: Catheter Dislodgements
time frame: 24 hours
description: Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.
measure: Opioid Consumption
time frame: 48 hours
description: Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV
measure: Time for Block Placement
time frame: immediately post-procedure
description: Calculate the time to perform the nerve block procedure.
arm group label: In-plane group
arm group type: Experimental
description: This group will receive an interscalene catheter placed with in-plane approach.
arm group label: Out-of-plane group
arm group type: Experimental
description: This group will receive an interscalene catheter with an out-of-plan approach.
intervention type: Device
intervention name: interscalene nerve catheter
arm group label: In-plane group
arm group label: Out-of-plane group
other name: Peripheral nerve catheter kit, B Braun (Bethlehem, PA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. doi: 10.1097/aap.0b013e31820d5ee6.
PMID: 21425511
citation: Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53.
PMID: 19258990
citation: Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7.
PMID: 19258989
responsible party type: Sponsor
mesh term: Shoulder Pain
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 