<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/NCT03007966</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00040354</org_study_id>
    <nct_id>NCT03007966</nct_id>
  </id_info>
  <brief_title>IINB vs. QLB for Elective Open Inguinal Herniorrhaphy</brief_title>
  <official_title>Ilioinguinal/Iliohypogastric vs. Quadratus Lumborum Nerve Blockade for Elective Open Inguinal Herniorrhaphy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain&#xD;
      can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be&#xD;
      treated with opioid therapy, but the literature supports that these agents are known to&#xD;
      create or exacerbate adverse effects and complications, including post-operative nausea and&#xD;
      vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional&#xD;
      anesthesia results in a decreased risk of the aforementioned complications.1 Because of this,&#xD;
      various regional anesthetic techniques have been developed to provide analgesia following&#xD;
      open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block&#xD;
      (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The&#xD;
      quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could&#xD;
      be as effective as IINB at providing pain control following open herniorrhaphy. Additionally,&#xD;
      because local anesthetic injected during a QLB has the potential to spread cranially into the&#xD;
      thoracic paravertebral space following its lumbar deposition it could lead to alleviation of&#xD;
      both somatic and visceral pain.3 This might therefore improve the quality and or duration of&#xD;
      analgesia as compared to the IINB. To the best of the author's knowledge there has been no&#xD;
      investigation comparing the efficacy, with regards to post-operative pain management, between&#xD;
      IINB and QLB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a double-blinded prospective randomized controlled equivalency trial&#xD;
      comparing QLB to IINB. Patients presenting for unilateral open inguinal herniorrhaphy who&#xD;
      agree to participate in the study and do not meet exclusion criteria will be randomized to&#xD;
      either receiving an IINB or a QLB for post-operative analgesia. After performing a timeout,&#xD;
      applying monitors (ECG, capnography, Sp02, non-invasive blood pressure), and confirming all&#xD;
      paperwork per the usual pre-procedural check list the study participants will be administered&#xD;
      procedural sedation (fentanyl and midazolam) to comfort as well as supplemental oxygen. The&#xD;
      anatomy of both block sites will be identified by palpation of landmarks, labeling of&#xD;
      structures with a skin marking pen, and visualization under ultrasound guidance. Both sites&#xD;
      will be administered a small skin wheal of lidocaine 1% at the site the block needle would be&#xD;
      introduced into the skin. Our intent with regards to administering a local anesthetic skin&#xD;
      wheal is to increase our success in blinding the patient to which block was actually&#xD;
      performed. A regional anesthetic block will only be performed at the randomized block site&#xD;
      (IINB vs. QLB). After 15-30 minutes post block or post operatively the block will be assessed&#xD;
      for success. Loss of cold sensation in the area of the surgical site would be indicative of&#xD;
      block success. The patient will then proceed to the operating room and receive a general&#xD;
      anesthetic with the final details of that anesthetic to be determined by the anesthesiologist&#xD;
      responsible for the patient in the operating room. We will ask the operating room&#xD;
      anesthesiologist and surgeon to avoid administration of medications that would confound our&#xD;
      results. Specifically, no additional local anesthetic is to be injected at the incision site,&#xD;
      no long acting opioids (hydromorphone, morphine, methadone etc…), dexamethasone or ketamine.&#xD;
      After completion of the procedure the patient will recover in the post anesthesia care unit&#xD;
      (PACU) where the participant will recover as per the usual process. The patient's discharge&#xD;
      disposition will be at the discretion of the surgeon and anesthesiologist responsible for the&#xD;
      participant's PACU care. The patient will be provided a diary that the participant will&#xD;
      complete at 8hrs and 24hrs post block that will help the participant compile the data&#xD;
      pertinent to the investigators primary and secondary outcomes. This diary should take no more&#xD;
      than a minute or two for each sampling time. Participants will receive two phone calls at&#xD;
      home to obtain this data at 8hrs and 24hrs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">February 17, 2018</completion_date>
  <primary_completion_date type="Actual">February 17, 2018</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Verbal Pain Score With Movement</measure>
    <time_frame>8 hrs Post Nerve Block</time_frame>
    <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Verbal Pain Score at Rest</measure>
    <time_frame>8 hrs Post Nerve Block</time_frame>
    <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Verbal Pain Score at Rest</measure>
    <time_frame>24 hrs Post Nerve Block</time_frame>
    <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Verbal Pain Score With Activity</measure>
    <time_frame>24hrs Post Nerve Block</time_frame>
    <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Oral Analgesic</measure>
    <time_frame>24hrs Post Nerve Block</time_frame>
    <description>When does the patient require their first post operative analgesic dose?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Onset of Post Operative Pain</measure>
    <time_frame>24hrs Post Nerve Block</time_frame>
    <description>When does the patient first note post operative pain?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Opioid Consumption</measure>
    <time_frame>24 hrs Post Nerve Block</time_frame>
    <description>Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Nausea</measure>
    <time_frame>8 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Itching</measure>
    <time_frame>24 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Itching</measure>
    <time_frame>8 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</measure>
    <time_frame>8 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Nausea</measure>
    <time_frame>24 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</measure>
    <time_frame>24 hrs Post Nerve Block</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nerve Block</condition>
  <condition>Herniorrhaphy</condition>
  <condition>Regional Anesthesia</condition>
  <arm_group>
    <arm_group_label>Ilioinguinal / Iliohypogastric Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ilioinguinal / Iliohypogastric Block</intervention_name>
    <description>Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
    <arm_group_label>Ilioinguinal / Iliohypogastric Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus Lumborum Block</intervention_name>
    <description>Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.</description>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.25%</intervention_name>
    <description>Administered as part of the local anesthetic mixture</description>
    <arm_group_label>Ilioinguinal / Iliohypogastric Block</arm_group_label>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine 1:200k</intervention_name>
    <description>Administered as part of the local anesthetic mixture</description>
    <arm_group_label>Ilioinguinal / Iliohypogastric Block</arm_group_label>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clonidine 1.66mcg/cc</intervention_name>
    <description>Administered as part of the local anesthetic mixture</description>
    <arm_group_label>Ilioinguinal / Iliohypogastric Block</arm_group_label>
    <arm_group_label>Quadratus Lumborum Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patient's scheduled for elective unilateral open inguinal hernia repair at WFUBMC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The anesthesiologist performing the intraoperative anesthetic deems the patient&#xD;
             inappropriate for general anesthesia.&#xD;
&#xD;
          -  If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on&#xD;
             extended release opioid formulations.&#xD;
&#xD;
          -  If there is a contraindication to the performance of a regional block&#xD;
&#xD;
          -  Concomitant anticoagulation use&#xD;
&#xD;
          -  Allergy to local anesthetic&#xD;
&#xD;
          -  Infectious or dermatologic conditions in the area of block placement that would&#xD;
             otherwise increase the risk of peripheral nerve blockade&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Institutionalized individuals&#xD;
&#xD;
          -  Extremes of age: Age &gt; 90 or &lt; 18&#xD;
&#xD;
          -  Non English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher J Edwards, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.</citation>
    <PMID>15108988</PMID>
  </reference>
  <reference>
    <citation>Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.</citation>
    <PMID>15025612</PMID>
  </reference>
  <reference>
    <citation>Børglum J, Jensen K, Moriggl B, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. BJA Out Blue E-Letters 2013. Available from http://bja.oxfordjournals. org/forum/topic/brjana_el%3B9919 (accessed 16 December 2015)</citation>
  </reference>
  <reference>
    <citation>Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.</citation>
    <PMID>12727037</PMID>
  </reference>
  <reference>
    <citation>Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. doi: 10.1093/bja/aei157. Epub 2005 May 27.</citation>
    <PMID>15923270</PMID>
  </reference>
  <reference>
    <citation>Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.</citation>
    <PMID>3450848</PMID>
  </reference>
  <reference>
    <citation>7. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010.</citation>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <results_first_submitted>October 2, 2019</results_first_submitted>
  <results_first_submitted_qc>November 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 18, 2019</results_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clonidine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03007966/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ilioinguinal / Iliohypogastric Block</title>
          <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
        </group>
        <group group_id="P2">
          <title>Quadratus Lumborum Block</title>
          <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did not meeting inclusion/exclusion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ilioinguinal / Iliohypogastric Block</title>
          <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
        </group>
        <group group_id="B2">
          <title>Quadratus Lumborum Block</title>
          <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</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="29"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="59"/>
          </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="53.4" spread="18.6"/>
                    <measurement group_id="B2" value="58.9" spread="11.2"/>
                    <measurement group_id="B3" value="56.2" spread="14.84"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.2" spread="4.3"/>
                    <measurement group_id="B2" value="26.4" spread="6.2"/>
                    <measurement group_id="B3" value="25.8" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Verbal Pain Score With Movement</title>
        <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.</description>
        <time_frame>8 hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Verbal Pain Score With Movement</title>
          <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.</description>
          <units>score 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="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.10" spread="3.02"/>
                    <measurement group_id="O2" value="5.03" spread="3.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Verbal Pain Score at Rest</title>
        <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
        <time_frame>8 hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Verbal Pain Score at Rest</title>
          <description>Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
          <units>score 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="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="3"/>
                    <measurement group_id="O2" value="3.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Verbal Pain Score at Rest</title>
        <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
        <time_frame>24 hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Verbal Pain Score at Rest</title>
          <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
          <units>score 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="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="2.4"/>
                    <measurement group_id="O2" value="2.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Verbal Pain Score With Activity</title>
        <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
        <time_frame>24hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Verbal Pain Score With Activity</title>
          <description>Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome</description>
          <units>score 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="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.5"/>
                    <measurement group_id="O2" value="5.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Oral Analgesic</title>
        <description>When does the patient require their first post operative analgesic dose?</description>
        <time_frame>24hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture&#xD;
Epinephrine 1:200k: Administered as part of the local anesthetic mixture&#xD;
Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Oral Analgesic</title>
          <description>When does the patient require their first post operative analgesic dose?</description>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141" lower_limit="71" upper_limit="742"/>
                    <measurement group_id="O2" value="91" lower_limit="58" upper_limit="390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Onset of Post Operative Pain</title>
        <description>When does the patient first note post operative pain?</description>
        <time_frame>24hrs Post Nerve Block</time_frame>
        <population>Data not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Onset of Post Operative Pain</title>
          <description>When does the patient first note post operative pain?</description>
          <population>Data not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Opioid Consumption</title>
        <description>Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent</description>
        <time_frame>24 hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption</title>
          <description>Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent</description>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
          <units>milligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="19"/>
                    <measurement group_id="O2" value="25.2" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Nausea</title>
        <time_frame>8 hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Nausea</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Itching</title>
        <time_frame>24 hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Itching</title>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</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="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Itching</title>
        <time_frame>8 hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Itching</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</title>
        <time_frame>8 hrs Post Nerve Block</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Nausea</title>
        <time_frame>24 hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Nausea</title>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</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="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</title>
        <time_frame>24 hrs Post Nerve Block</time_frame>
        <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</population>
        <group_list>
          <group group_id="O1">
            <title>Ilioinguinal / Iliohypogastric Block</title>
            <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Block</title>
            <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Presence of Opioid Related Side Effects--Vomiting</title>
          <population>One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.</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="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 - 24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ilioinguinal / Iliohypogastric Block</title>
          <description>Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Ilioinguinal / Iliohypogastric Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.</description>
        </group>
        <group group_id="E2">
          <title>Quadratus Lumborum Block</title>
          <description>Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.&#xD;
Quadratus Lumborum Block: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.&#xD;
Bupivacaine 0.25%: Administered as part of the local anesthetic mixture Epinephrine 1:200k: Administered as part of the local anesthetic mixture Clonidine 1.66mcg/c</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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="12" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="30"/>
              </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>Christopher Edwards</name_or_title>
      <organization>Wake Forest University Health Sciences</organization>
      <phone>336-716-4498</phone>
      <email>chedward@wakehealth.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/NCT03007966
org study id: IRB00040354
nct id: NCT03007966
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Open inguinal herniorrhaphy is a common outpatient surgical procedure. Post-operative pain
      can be a significant hindrance to discharge from the post anesthesia care unit. Pain can be
      treated with opioid therapy, but the literature supports that these agents are known to
      create or exacerbate adverse effects and complications, including post-operative nausea and
      vomiting, hypoxia, and urinary retention. In contrast, analgesia provided by regional
      anesthesia results in a decreased risk of the aforementioned complications.1 Because of this,
      various regional anesthetic techniques have been developed to provide analgesia following
      open herniorrhaphy. One technique is a combined ilioinguinal and iliohypogastric nerve block
      (IINB), which has been shown to decrease the initial pain after inguinal herniorrhaphy.2 The
      quadratus lumborum block (QLB) is a newer regional anesthetic technique that we think could
      be as effective as IINB at providing pain control following open herniorrhaphy. Additionally,
      because local anesthetic injected during a QLB has the potential to spread cranially into the
      thoracic paravertebral space following its lumbar deposition it could lead to alleviation of
      both somatic and visceral pain.3 This might therefore improve the quality and or duration of
      analgesia as compared to the IINB. To the best of the author's knowledge there has been no
      investigation comparing the efficacy, with regards to post-operative pain management, between
      IINB and QLB.
This study will be a double-blinded prospective randomized controlled equivalency trial
      comparing QLB to IINB. Patients presenting for unilateral open inguinal herniorrhaphy who
      agree to participate in the study and do not meet exclusion criteria will be randomized to
      either receiving an IINB or a QLB for post-operative analgesia. After performing a timeout,
      applying monitors (ECG, capnography, Sp02, non-invasive blood pressure), and confirming all
      paperwork per the usual pre-procedural check list the study participants will be administered
      procedural sedation (fentanyl and midazolam) to comfort as well as supplemental oxygen. The
      anatomy of both block sites will be identified by palpation of landmarks, labeling of
      structures with a skin marking pen, and visualization under ultrasound guidance. Both sites
      will be administered a small skin wheal of lidocaine 1% at the site the block needle would be
      introduced into the skin. Our intent with regards to administering a local anesthetic skin
      wheal is to increase our success in blinding the patient to which block was actually
      performed. A regional anesthetic block will only be performed at the randomized block site
      (IINB vs. QLB). After 15-30 minutes post block or post operatively the block will be assessed
      for success. Loss of cold sensation in the area of the surgical site would be indicative of
      block success. The patient will then proceed to the operating room and receive a general
      anesthetic with the final details of that anesthetic to be determined by the anesthesiologist
      responsible for the patient in the operating room. We will ask the operating room
      anesthesiologist and surgeon to avoid administration of medications that would confound our
      results. Specifically, no additional local anesthetic is to be injected at the incision site,
      no long acting opioids (hydromorphone, morphine, methadone etc…), dexamethasone or ketamine.
      After completion of the procedure the patient will recover in the post anesthesia care unit
      (PACU) where the participant will recover as per the usual process. The patient's discharge
      disposition will be at the discretion of the surgeon and anesthesiologist responsible for the
      participant's PACU care. The patient will be provided a diary that the participant will
      complete at 8hrs and 24hrs post block that will help the participant compile the data
      pertinent to the investigators primary and secondary outcomes. This diary should take no more
      than a minute or two for each sampling time. Participants will receive two phone calls at
      home to obtain this data at 8hrs and 24hrs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Post-operative Verbal Pain Score With Movement
time frame: 8 hrs Post Nerve Block
description: Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.
measure: Post-operative Verbal Pain Score at Rest
time frame: 8 hrs Post Nerve Block
description: Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome
measure: Post-operative Verbal Pain Score at Rest
time frame: 24 hrs Post Nerve Block
description: Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
measure: Post-operative Verbal Pain Score With Activity
time frame: 24hrs Post Nerve Block
description: Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome
measure: Time to First Oral Analgesic
time frame: 24hrs Post Nerve Block
description: When does the patient require their first post operative analgesic dose?
measure: Time to Onset of Post Operative Pain
time frame: 24hrs Post Nerve Block
description: When does the patient first note post operative pain?
measure: Total Opioid Consumption
time frame: 24 hrs Post Nerve Block
description: Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent
measure: Number of Participants With Presence of Opioid Related Side Effects--Nausea
time frame: 8 hrs Post Nerve Block
measure: Number of Participants With Presence of Opioid Related Side Effects--Itching
time frame: 24 hrs Post Nerve Block
measure: Number of Participants With Presence of Opioid Related Side Effects--Itching
time frame: 8 hrs Post Nerve Block
measure: Number of Participants With Presence of Opioid Related Side Effects--Vomiting
time frame: 8 hrs Post Nerve Block
measure: Number of Participants With Presence of Opioid Related Side Effects--Nausea
time frame: 24 hrs Post Nerve Block
measure: Number of Participants With Presence of Opioid Related Side Effects--Vomiting
time frame: 24 hrs Post Nerve Block
arm group label: Ilioinguinal / Iliohypogastric Block
arm group type: Active Comparator
description: Patient's randomized to receive an Ilioinguinal / Iliohypogastric nerve block (IINB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a supine position in a manner consistent with the technique described by Willschke, but modified to utilize an in-plane technique rather than an out-of-plane technique for needle to ultrasound probe orientation. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
arm group label: Quadratus Lumborum Block
arm group type: Experimental
description: Patient's randomized to receive a Quadratus Lumborum block (QLB) for post operative analgesia following inguinal herniorrhaphy will have said block performed in a lateral position in a manner consistent with the technique described by Børglum. Either a Sonosite linear HFL38x/13-6 MHz or Sonosite curvilinear C60x/5-2 MHz probe will be utilized to visualize the pertinent ultrasound anatomy. A Pajunk 21g x 100mm Sono Plex Stim Cannula will be utilized to appropriately deposit a single local anesthetic aliquot consisting of 25cc's of bupivacaine 0.25% with epinephrine 5mcg/cc and clonidine 1.66mcg/cc.
intervention type: Procedure
intervention name: Ilioinguinal / Iliohypogastric Block
description: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
arm group label: Ilioinguinal / Iliohypogastric Block
intervention type: Procedure
intervention name: Quadratus Lumborum Block
description: Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
arm group label: Quadratus Lumborum Block
intervention type: Drug
intervention name: Bupivacaine 0.25%
description: Administered as part of the local anesthetic mixture
arm group label: Ilioinguinal / Iliohypogastric Block
arm group label: Quadratus Lumborum Block
intervention type: Drug
intervention name: Epinephrine 1:200k
description: Administered as part of the local anesthetic mixture
arm group label: Ilioinguinal / Iliohypogastric Block
arm group label: Quadratus Lumborum Block
intervention type: Drug
intervention name: Clonidine 1.66mcg/cc
description: Administered as part of the local anesthetic mixture
arm group label: Ilioinguinal / Iliohypogastric Block
arm group label: Quadratus Lumborum Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Christopher J Edwards, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706. doi: 10.1097/00000542-200403000-00034.
PMID: 15108988
citation: Toivonen J, Permi J, Rosenberg PH. Analgesia and discharge following preincisional ilioinguinal and iliohypogastric nerve block combined with general or spinal anaesthesia for inguinal herniorrhaphy. Acta Anaesthesiol Scand. 2004 Apr;48(4):480-5. doi: 10.1111/j.1399-6576.2004.00346.x.
PMID: 15025612
citation: Børglum J, Jensen K, Moriggl B, et al. Ultrasound-Guided Transmuscular Quadratus Lumborum Blockade. BJA Out Blue E-Letters 2013. Available from http://bja.oxfordjournals. org/forum/topic/brjana_el%3B9919 (accessed 16 December 2015)
citation: Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Manage. 2003 May;25(5):406-11. doi: 10.1016/s0885-3924(03)00162-3.
PMID: 12727037
citation: Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. doi: 10.1093/bja/aei157. Epub 2005 May 27.
PMID: 15923270
citation: Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PMID: 3450848
citation: 7. Julious SA. Sample Sizes for Clinical Trials. Chapman and Hall/CRC, Boca Raton, FL, 2010.
responsible party type: Sponsor
mesh term: Clonidine
mesh term: Epinephrine
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 