<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/NCT01693900</url>
  </required_header>
  <id_info>
    <org_study_id>2011-285</org_study_id>
    <nct_id>NCT01693900</nct_id>
  </id_info>
  <brief_title>Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery</brief_title>
  <official_title>Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Randy Fayne, DO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical trauma causes nerve sensitization leading to amplification and prolongation of&#xD;
      postoperative pain. In experimental studies, pre-injury neural blockade using local&#xD;
      anesthetics has been shown to reduce post-injury sensitization of the central nervous system,&#xD;
      while similar techniques applied after the injury had less or no effect (FILOS).&#xD;
      Investigators have therefore designed this study to examine the timing of FICB&#xD;
      (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing&#xD;
      anterior hip replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Though still uncommonly used in the United States, the popularity of the anterior approach&#xD;
      for total hip replacement is rapidly growing because of its clinical advantages.&#xD;
      Rehabilitation is simplified and accelerated, dislocation risk is reduced, leg length is more&#xD;
      accurately controlled, and incision is smaller than with traditional approaches (GOEBEL).&#xD;
      Nevertheless, although pain is lessened, it is still considerable, and new techniques have&#xD;
      been developed to improve postoperative pain control for this procedure.&#xD;
&#xD;
      Surgical incision and tissue trauma result in postoperative pain. Regional pain blocks,&#xD;
      especially when done under ultrasound guidance, have proven to be extremely effective at&#xD;
      reducing postoperative pain and improving patient satisfaction. One such block, the fascia&#xD;
      iliaca compartment block (FICB), has been shown to be effective in controlling pain&#xD;
      associated with surgery involving the hip and femur.&#xD;
&#xD;
      Although possible without ultrasound guidance, using this technique allows for identification&#xD;
      of specific tissue planes and precise placement of medication near the nerves responsible for&#xD;
      postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle&#xD;
      is identified at the anterior edge of the ilium, and a needle is placed just beneath that&#xD;
      fascia. A high volume of local anesthetic is then injected under ultrasound guidance,&#xD;
      ensuring cephalad spread of medication, in an attempt to provide anesthesia of the lateral&#xD;
      femoral cutaneous, femoral and obturator nerves.&#xD;
&#xD;
      Unlike other approaches to hip replacement, anterior repair allows for direct visualization&#xD;
      of the fascial layers described above. This allows for direct injection of local anesthetic&#xD;
      beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound&#xD;
      guided, FICB. The primary differences in approach (ultrasound guided preop versus direct&#xD;
      visualization intraop) is the timing of injection, and it is unclear if nerve block prior to&#xD;
      or after tissue damage affects postoperative pain in these patients.&#xD;
&#xD;
      Surgical trauma causes nerve sensitization leading to amplification and prolongation of&#xD;
      postoperative pain. In experimental studies, pre-injury neural blockade using local&#xD;
      anesthetics has been shown to reduce post-injury sensitization of the central nervous system,&#xD;
      while similar techniques applied after the injury had less or no effect (FILOS).&#xD;
      Investigators have therefore designed this study to examine the timing of FICB&#xD;
      (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing&#xD;
      anterior hip replacement surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain During PACU Admission</measure>
    <time_frame>From time of PACU admission until discharge from PACU, an average of 2 hours</time_frame>
    <description>Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:&#xD;
Baseline assessment in Preoperative area&#xD;
Upon arrival to the post-anesthesia care unit (PACU)&#xD;
Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain During Recovery</measure>
    <time_frame>From discharge from PACU until discharge from hospital, an average of 2-3 days</time_frame>
    <description>Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.</time_frame>
    <description>Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Postoperative Pain Control</measure>
    <time_frame>At the 3 week post-op visit</time_frame>
    <description>Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Pre-operative Ultrasound FICB Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intra-operative FICB Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pre-operative Ultrasound FICB Group</intervention_name>
    <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator in the preoperative area. Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.</description>
    <arm_group_label>Pre-operative Ultrasound FICB Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intra-operative FICB Group</intervention_name>
    <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
    <arm_group_label>Intra-operative FICB Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18-65 years of age&#xD;
&#xD;
          -  Female patients must be surgically sterile, postmenopausal or have a negative&#xD;
             pregnancy test on the day of surgery&#xD;
&#xD;
          -  Willing and able to sign the informed consent approved by the Institutional Review&#xD;
             Board (IRB)&#xD;
&#xD;
          -  Willing and able to complete the study procedures and pain scales, and to communicate&#xD;
             meaningfully in English with study personnel&#xD;
&#xD;
          -  Elective anterior hip replacement to be performed at Beaumont Hospital, Royal Oak&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification 1, 2, and 3&#xD;
             (patients that have either no systemic illness, or mild to moderate systemic disease,&#xD;
             eg. asthma, diabetes or hypertension)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to study medications including ropivacaine and other local&#xD;
             anesthetic agents of the amide-type&#xD;
&#xD;
          -  Enrollment in concurrent research study&#xD;
&#xD;
          -  Female patients who are pregnant or lactating, or who have a positive urine pregnancy&#xD;
             test&#xD;
&#xD;
          -  Opioid tolerant, ie, A patient taking a narcotic &gt; 30mg per day morphine equivalent.&#xD;
             (Source: www.globalrph.com/narcotic.cgi) for pain in the 2 months prior to surgery&#xD;
&#xD;
          -  A medical condition that in the investigator's opinion could adversely impact the&#xD;
             patient's participation or safety, conducts of the study, or interferes with the pain&#xD;
             assessments&#xD;
&#xD;
          -  Previous hip arthroplasty (partial or total) of the index hip&#xD;
&#xD;
          -  History of illicit drug use, or prescription medicine or alcohol abuse within the past&#xD;
             2 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Randy Fayne, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beaumont Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Health System</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>January 9, 2017</results_first_submitted>
  <results_first_submitted_qc>March 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2017</results_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Randy Fayne, DO</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>joint replacement</keyword>
  <keyword>total hip replacement</keyword>
  <keyword>regional pain block</keyword>
  <keyword>ultrasound guidance</keyword>
  <keyword>fascia iliaca compartment block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This single-center, prospective, randomized study enrolled 50 subjects who were scheduled for elective anterior hip replacement. Once informed consent was obtained, patients were randomized to either preoperative ultrasound-guided fascia iliaca compartment block (FICB) or intraoperative surgeon-placed FICB.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pre-operative Ultrasound FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
        </group>
        <group group_id="P2">
          <title>Intra-operative FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data lost for one participant in Intra-operative FICB group leaving 24 analyzed for all measures.</population>
      <group_list>
        <group group_id="B1">
          <title>Pre-operative Ultrasound FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
        </group>
        <group group_id="B2">
          <title>Intra-operative FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</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="25"/>
            <count group_id="B2" value="24"/>
            <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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </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>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="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <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>Postoperative Pain During PACU Admission</title>
        <description>Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:&#xD;
Baseline assessment in Preoperative area&#xD;
Upon arrival to the post-anesthesia care unit (PACU)&#xD;
Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject.</description>
        <time_frame>From time of PACU admission until discharge from PACU, an average of 2 hours</time_frame>
        <population>Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-operative Ultrasound FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
          </group>
          <group group_id="O2">
            <title>Intra-operative FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain During PACU Admission</title>
          <description>Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:&#xD;
Baseline assessment in Preoperative area&#xD;
Upon arrival to the post-anesthesia care unit (PACU)&#xD;
Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject.</description>
          <population>Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.</population>
          <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="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" lower_limit="35" upper_limit="44"/>
                    <measurement group_id="O2" value="36" lower_limit="26" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain During Recovery</title>
        <description>Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.</description>
        <time_frame>From discharge from PACU until discharge from hospital, an average of 2-3 days</time_frame>
        <population>Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-operative Ultrasound FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
          </group>
          <group group_id="O2">
            <title>Intra-operative FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain During Recovery</title>
          <description>Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.</description>
          <population>Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group</population>
          <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="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" lower_limit="15" upper_limit="50"/>
                    <measurement group_id="O2" value="26" lower_limit="11" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Adverse Events</title>
        <description>Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.</description>
        <time_frame>From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.</time_frame>
        <population>Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-operative Ultrasound FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
          </group>
          <group group_id="O2">
            <title>Intra-operative FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Adverse Events</title>
          <description>Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.</description>
          <population>Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Postoperative Pain Control</title>
        <description>Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.</description>
        <time_frame>At the 3 week post-op visit</time_frame>
        <population>Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.</population>
        <group_list>
          <group group_id="O1">
            <title>Pre-operative Ultrasound FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
          </group>
          <group group_id="O2">
            <title>Intra-operative FICB Group</title>
            <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Postoperative Pain Control</title>
          <description>Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.</description>
          <population>Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="0.6"/>
                    <measurement group_id="O2" value="8.8" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were assessed from time of consent until end of study at the 3 week-postoperative assessment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pre-operative Ultrasound FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.&#xD;
Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.</description>
        </group>
        <group group_id="E2">
          <title>Intra-operative FICB Group</title>
          <description>Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.&#xD;
Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Acute blood loss anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Swelling of knee/thigh</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Swelling of lips</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Tape burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </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>
    <limitations_and_caveats>Small sample size limited conclusions that could be drawn.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Randy Fayne, DO</name_or_title>
      <organization>Beaumont Health</organization>
      <phone>248-898-1905</phone>
      <email>rfyane@beaumont.org</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/NCT01693900
org study id: 2011-285
nct id: NCT01693900
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Surgical trauma causes nerve sensitization leading to amplification and prolongation of
      postoperative pain. In experimental studies, pre-injury neural blockade using local
      anesthetics has been shown to reduce post-injury sensitization of the central nervous system,
      while similar techniques applied after the injury had less or no effect (FILOS).
      Investigators have therefore designed this study to examine the timing of FICB
      (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing
      anterior hip replacement surgery.
Though still uncommonly used in the United States, the popularity of the anterior approach
      for total hip replacement is rapidly growing because of its clinical advantages.
      Rehabilitation is simplified and accelerated, dislocation risk is reduced, leg length is more
      accurately controlled, and incision is smaller than with traditional approaches (GOEBEL).
      Nevertheless, although pain is lessened, it is still considerable, and new techniques have
      been developed to improve postoperative pain control for this procedure.

      Surgical incision and tissue trauma result in postoperative pain. Regional pain blocks,
      especially when done under ultrasound guidance, have proven to be extremely effective at
      reducing postoperative pain and improving patient satisfaction. One such block, the fascia
      iliaca compartment block (FICB), has been shown to be effective in controlling pain
      associated with surgery involving the hip and femur.

      Although possible without ultrasound guidance, using this technique allows for identification
      of specific tissue planes and precise placement of medication near the nerves responsible for
      postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle
      is identified at the anterior edge of the ilium, and a needle is placed just beneath that
      fascia. A high volume of local anesthetic is then injected under ultrasound guidance,
      ensuring cephalad spread of medication, in an attempt to provide anesthesia of the lateral
      femoral cutaneous, femoral and obturator nerves.

      Unlike other approaches to hip replacement, anterior repair allows for direct visualization
      of the fascial layers described above. This allows for direct injection of local anesthetic
      beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound
      guided, FICB. The primary differences in approach (ultrasound guided preop versus direct
      visualization intraop) is the timing of injection, and it is unclear if nerve block prior to
      or after tissue damage affects postoperative pain in these patients.

      Surgical trauma causes nerve sensitization leading to amplification and prolongation of
      postoperative pain. In experimental studies, pre-injury neural blockade using local
      anesthetics has been shown to reduce post-injury sensitization of the central nervous system,
      while similar techniques applied after the injury had less or no effect (FILOS).
      Investigators have therefore designed this study to examine the timing of FICB
      (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing
      anterior hip replacement surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative Pain During PACU Admission
time frame: From time of PACU admission until discharge from PACU, an average of 2 hours
description: Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:
Baseline assessment in Preoperative area
Upon arrival to the post-anesthesia care unit (PACU)
Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject.
measure: Postoperative Pain During Recovery
time frame: From discharge from PACU until discharge from hospital, an average of 2-3 days
description: Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.
measure: Incidence of Adverse Events
time frame: From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.
description: Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.
measure: Patient Satisfaction With Postoperative Pain Control
time frame: At the 3 week post-op visit
description: Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.
arm group label: Pre-operative Ultrasound FICB Group
arm group type: Experimental
description: Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.
arm group label: Intra-operative FICB Group
arm group type: Active Comparator
description: Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.
intervention type: Procedure
intervention name: Pre-operative Ultrasound FICB Group
description: Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator in the preoperative area. Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.
arm group label: Pre-operative Ultrasound FICB Group
intervention type: Procedure
intervention name: Intra-operative FICB Group
description: Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
arm group label: Intra-operative FICB Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Randy Fayne, DO
role: Principal Investigator
affiliation: Beaumont Health System
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Randy Fayne, DO
investigator title: Principle Investigator
mesh term: Pain, Postoperative
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size limited conclusions that could be drawn.
point of contact: 