<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/NCT01688596</url>
  </required_header>
  <id_info>
    <org_study_id>40708</org_study_id>
    <nct_id>NCT01688596</nct_id>
  </id_info>
  <brief_title>Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy</brief_title>
  <official_title>Infiltration of Bupivacaine Local Anesthetic to Trocar Insertion Sites After Laparoscopic Hysterectomy: A Randomized, Double-Blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess if injection of local anesthetic to the&#xD;
      laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain&#xD;
      after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The growing interest in minimally invasive gynecologic surgeries have increased the number of&#xD;
      patients undergoing laparoscopic hysterectomies. Although many patients are being discharged&#xD;
      home the same day of surgery, majority of patients complain of immediate postoperative pain&#xD;
      after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves&#xD;
      over a short period of time, infiltration of local anesthetic to trocar insertion sites might&#xD;
      alleviate the patient's discomfort during the recovery period. Immediate post-operative pain&#xD;
      relief further facilitates early discharge and faster patient recovery.&#xD;
&#xD;
      Published data regarding the effects of preemptive port site local anesthesia in gynecologic&#xD;
      operative laparoscopy have been limited and controversial. Visceral pain control through&#xD;
      afferent nerve block could minimize pain perception especially during the first postoperative&#xD;
      hours. This study aims to assess the influence of infiltration of local anesthetic to trocar&#xD;
      insertion sites after laparoscopic hysterectomy on postoperative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)</measure>
    <time_frame>4 hours</time_frame>
    <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Score</measure>
    <time_frame>6 hours</time_frame>
    <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Score</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss &gt; 200 mL</measure>
    <time_frame>day of surgery after procedure completion</time_frame>
    <description>Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as &gt;200 mL vs. &lt;= 200 mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Complications</measure>
    <time_frame>From date of randomization up to 12 months</time_frame>
    <description>Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating Time</measure>
    <time_frame>start to end of patient's surgery</time_frame>
    <description>Operating time measured in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay &gt;= 24 Hours</measure>
    <time_frame>from time surgery completed to time patient discharged</time_frame>
    <description>Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histopathologic Diagnosis</measure>
    <time_frame>Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.</time_frame>
    <description>Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Primary Surgical Finding</measure>
    <time_frame>Surgical findings will be measured on the day of surgery after completing the procedure.</time_frame>
    <description>The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>No Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
    <arm_group_label>Bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled for a laparoscopic hysterectomy for benign indications at&#xD;
             the Department of Obstetrics &amp; Gynecology's Division of Minimally Invasive Surgery at&#xD;
             Milton S. Hershey Medical Center will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are scheduled for a hysterectomy through the vaginal or abdominal&#xD;
             approach will be excluded. Patients with preoperative indications of endometriosis or&#xD;
             chronic pelvic pain will also be excluded since these patients could potentially have&#xD;
             higher thresholds of pain.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerald Harkins, MD</last_name>
    <role>Study Director</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria Teresa Tam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Davies, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Milton S. Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.</citation>
    <PMID>15572499</PMID>
  </reference>
  <reference>
    <citation>Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005 Jul-Aug;33(4):372-8. doi: 10.1177/147323000503300402.</citation>
    <PMID>16104440</PMID>
  </reference>
  <reference>
    <citation>Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6.</citation>
    <PMID>11342725</PMID>
  </reference>
  <reference>
    <citation>Ghezzi F, Cromi A, Bergamini V, Raffaelli R, Crotti S, Segredini R, Bolis P. Preemptive port site local anesthesia in gynecologic laparoscopy: a randomized, controlled trial. J Minim Invasive Gynecol. 2005 May-Jun;12(3):210-5. doi: 10.1016/j.jmig.2005.03.007.</citation>
    <PMID>15922977</PMID>
  </reference>
  <reference>
    <citation>Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.</citation>
    <PMID>22763313</PMID>
  </reference>
  <reference>
    <citation>Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.</citation>
    <PMID>16036193</PMID>
  </reference>
  <reference>
    <citation>Fong SY, Pavy TJ, Yeo ST, Paech MJ, Gurrin LC. Assessment of wound infiltration with bupivacaine in women undergoing day-case gynecological laparoscopy. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):131-6. doi: 10.1053/rapm.2001.21836.</citation>
    <PMID>11251136</PMID>
  </reference>
  <reference>
    <citation>Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.</citation>
    <PMID>9840560</PMID>
  </reference>
  <reference>
    <citation>Salman MA, Yucebas ME, Coskun F, Aypar U. Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia. Acta Anaesthesiol Scand. 2000 May;44(5):536-42. doi: 10.1034/j.1399-6576.2000.00508.x.</citation>
    <PMID>10786738</PMID>
  </reference>
  <reference>
    <citation>Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.</citation>
    <PMID>10910857</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <results_first_submitted>January 4, 2017</results_first_submitted>
  <results_first_submitted_qc>July 31, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2019</results_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Matthew Davies</investigator_full_name>
    <investigator_title>Professor, Division of Urogynecology and Minimally Invasive GYN Surgery</investigator_title>
  </responsible_party>
  <keyword>Local</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Pain</keyword>
  <keyword>Laparoscopic hysterectomy</keyword>
  <keyword>Trocar site</keyword>
  <keyword>Port site</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients undergoing laparoscopic surgery at Penn State Milton S. Hershey Medical Center were recruited between 3/13 and 6/13. Allocated to CPP or no CPP based on usual clinical definitions.</recruitment_details>
      <pre_assignment_details>Patients in each group (Chronic Pelvic Pain and No Chronic Pelvic Pain) were randomized to receive either a bupivacaine block at each trocar site or no block. Standardization of amount of local block received was based on trocar size of 5mm or less vs. 8mm and or greater.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>No Treatment</title>
          <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
        </group>
        <group group_id="P2">
          <title>Bupivacaine</title>
          <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>No Treatment</title>
          <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
        </group>
        <group group_id="B2">
          <title>Bupivacaine</title>
          <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</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="67"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="135"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.3" spread="8.4"/>
                    <measurement group_id="B2" value="38.6" spread="10.5"/>
                    <measurement group_id="B3" value="38.5" spread="9.5"/>
                  </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="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic Pelvic Pain</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)</title>
        <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
        <time_frame>4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)</title>
          <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.4"/>
                    <measurement group_id="O2" value="3.4" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Score</title>
        <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Score</title>
          <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.3"/>
                    <measurement group_id="O2" value="4.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Score</title>
        <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
        <time_frame>24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Score</title>
          <description>Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to &quot;no pain&quot; and 10 equates to &quot;unable to move&quot;.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.4"/>
                    <measurement group_id="O2" value="4.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss &gt; 200 mL</title>
        <description>Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as &gt;200 mL vs. &lt;= 200 mL.</description>
        <time_frame>day of surgery after procedure completion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss &gt; 200 mL</title>
          <description>Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as &gt;200 mL vs. &lt;= 200 mL.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgical Complications</title>
        <description>Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.</description>
        <time_frame>From date of randomization up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgical Complications</title>
          <description>Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operating Time</title>
        <description>Operating time measured in minutes</description>
        <time_frame>start to end of patient's surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Operating Time</title>
          <description>Operating time measured in minutes</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3" spread="33.9"/>
                    <measurement group_id="O2" value="63.8" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay &gt;= 24 Hours</title>
        <description>Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.</description>
        <time_frame>from time surgery completed to time patient discharged</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay &gt;= 24 Hours</title>
          <description>Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Histopathologic Diagnosis</title>
        <description>Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.</description>
        <time_frame>Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Histopathologic Diagnosis</title>
          <description>Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Endometriosis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Leiomyoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adenomyosis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Primary Surgical Finding</title>
        <description>The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.</description>
        <time_frame>Surgical findings will be measured on the day of surgery after completing the procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>No Treatment</title>
            <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Surgical Finding</title>
          <description>The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Endometriosis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pelvic adhesive disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Leiomyoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>No Treatment</title>
          <description>The &quot;No Treatment&quot; group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.</description>
        </group>
        <group group_id="E2">
          <title>Bupivacaine</title>
          <description>The &quot;Bupivacaine Arm&quot; includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.&#xD;
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Matthew F. Davies, M.D.</name_or_title>
      <organization>Penn State Milton S. Hershey Medical Center</organization>
      <phone>7175310003 ext 283519</phone>
      <email>mdavies@hmc.psu.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/NCT01688596
org study id: 40708
nct id: NCT01688596
lead sponsor: 
has dmc: Yes
The primary objective of this study is to assess if injection of local anesthetic to the
      laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain
      after surgery.
The growing interest in minimally invasive gynecologic surgeries have increased the number of
      patients undergoing laparoscopic hysterectomies. Although many patients are being discharged
      home the same day of surgery, majority of patients complain of immediate postoperative pain
      after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves
      over a short period of time, infiltration of local anesthetic to trocar insertion sites might
      alleviate the patient's discomfort during the recovery period. Immediate post-operative pain
      relief further facilitates early discharge and faster patient recovery.

      Published data regarding the effects of preemptive port site local anesthesia in gynecologic
      operative laparoscopy have been limited and controversial. Visceral pain control through
      afferent nerve block could minimize pain perception especially during the first postoperative
      hours. This study aims to assess the influence of infiltration of local anesthetic to trocar
      insertion sites after laparoscopic hysterectomy on postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)
time frame: 4 hours
description: Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".
measure: Postoperative Pain Score
time frame: 6 hours
description: Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".
measure: Postoperative Pain Score
time frame: 24 hours
description: Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to "no pain" and 10 equates to "unable to move".
measure: Estimated Blood Loss > 200 mL
time frame: day of surgery after procedure completion
description: Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as >200 mL vs. <= 200 mL.
measure: Surgical Complications
time frame: From date of randomization up to 12 months
description: Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.
measure: Operating Time
time frame: start to end of patient's surgery
description: Operating time measured in minutes
measure: Length of Hospital Stay >= 24 Hours
time frame: from time surgery completed to time patient discharged
description: Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.
measure: Histopathologic Diagnosis
time frame: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.
description: Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.
measure: Primary Surgical Finding
time frame: Surgical findings will be measured on the day of surgery after completing the procedure.
description: The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.
arm group label: No Treatment
arm group type: No Intervention
description: The "No Treatment" group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine.
arm group label: Bupivacaine
arm group type: Active Comparator
description: The "Bupivacaine Arm" includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
arm group label: Bupivacaine
other name: Marcaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gerald Harkins, MD
role: Study Director
affiliation: Milton S. Hershey Medical Center
last name: Maria Teresa Tam, MD
role: Principal Investigator
affiliation: Milton S. Hershey Medical Center
last name: Matthew Davies, MD
role: Study Chair
affiliation: Milton S. Hershey Medical Center
facility: 
country: United States
citation: Einarsson JI, Sun J, Orav J, Young AE. Local analgesia in laparoscopy: a randomized trial. Obstet Gynecol. 2004 Dec;104(6):1335-9. doi: 10.1097/01.AOG.0000146283.90934.fd.
PMID: 15572499
citation: Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005 Jul-Aug;33(4):372-8. doi: 10.1177/147323000503300402.
PMID: 16104440
citation: Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6.
PMID: 11342725
citation: Ghezzi F, Cromi A, Bergamini V, Raffaelli R, Crotti S, Segredini R, Bolis P. Preemptive port site local anesthesia in gynecologic laparoscopy: a randomized, controlled trial. J Minim Invasive Gynecol. 2005 May-Jun;12(3):210-5. doi: 10.1016/j.jmig.2005.03.007.
PMID: 15922977
citation: Marks JL, Ata B, Tulandi T. Systematic review and metaanalysis of intraperitoneal instillation of local anesthetics for reduction of pain after gynecologic laparoscopy. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):545-53. doi: 10.1016/j.jmig.2012.04.002. Epub 2012 Jul 3.
PMID: 22763313
citation: Chou YJ, Ou YC, Lan KC, Jawan B, Chang SY, Kung FT. Preemptive analgesia installation during gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol. 2005 Jul-Aug;12(4):330-5. doi: 10.1016/j.jmig.2005.05.005.
PMID: 16036193
citation: Fong SY, Pavy TJ, Yeo ST, Paech MJ, Gurrin LC. Assessment of wound infiltration with bupivacaine in women undergoing day-case gynecological laparoscopy. Reg Anesth Pain Med. 2001 Mar-Apr;26(2):131-6. doi: 10.1053/rapm.2001.21836.
PMID: 11251136
citation: Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
PMID: 9840560
citation: Salman MA, Yucebas ME, Coskun F, Aypar U. Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia. Acta Anaesthesiol Scand. 2000 May;44(5):536-42. doi: 10.1034/j.1399-6576.2000.00508.x.
PMID: 10786738
citation: Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.
PMID: 10910857
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Matthew Davies
investigator title: Professor, Division of Urogynecology and Minimally Invasive GYN Surgery
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 