<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/NCT03283436</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001804</org_study_id>
    <nct_id>NCT03283436</nct_id>
  </id_info>
  <brief_title>RCT Superior Hypogastric Block During LH</brief_title>
  <official_title>Superior Hypogastric Plexus Block During Laparoscopic Hysterectomy: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jon I. Einarsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      The goal of this study is to assess the efficacy of a superior hypogastric plexus block&#xD;
      (SHPB) for pain relief following a laparoscopic hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to assess the efficacy of a SHPB for pain relief following&#xD;
      laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and&#xD;
      supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role&#xD;
      in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB&#xD;
      using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption&#xD;
      following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid&#xD;
      consumption will be collected from the Medication Administration Record by the nursing staff.&#xD;
      The nursing staff will also be asked to complete a recovery worksheet that details the Visual&#xD;
      Analog Scale pain score and opioid administration on admission to the recovery unit and every&#xD;
      postoperative hour until six hours or the patient is discharged. Patients will also be asked&#xD;
      to complete a daily diary for one week following the procedure, which details their pain&#xD;
      level and daily opioid consumption. Patients will be followed for thirty days after surgery&#xD;
      to assess for the occurrence of any postoperative complications. Detailed patient and&#xD;
      procedure characteristics including age, race, body mass index, parity, surgical history,&#xD;
      surgery indication, procedure type, and surgical approach will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2018</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">February 21, 2019</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
    <masking_description>Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain Scores</measure>
    <time_frame>Admission to recovery unit and every hour after for 2 hours</time_frame>
    <description>The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Opioid Use</measure>
    <time_frame>Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery</time_frame>
    <description>Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain Scores</measure>
    <time_frame>Discharge to 1 week after surgery, assessed up to 1 week after surgery</time_frame>
    <description>Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hysterectomy</condition>
  <arm_group>
    <arm_group_label>Superior hypogastric plexus block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No block</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control arm will undergo the hysterectomy with no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Hydrochloride 0.25% Injection Solution</intervention_name>
    <description>10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
    <arm_group_label>Superior hypogastric plexus block</arm_group_label>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over age 18&#xD;
&#xD;
          -  English Speaking&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Undergoing laparoscopic hysterectomy for benign indications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned laparotomy incision&#xD;
&#xD;
          -  Planned procedure that requires dissection of the presacral space&#xD;
&#xD;
          -  Allergy to block medication (s)&#xD;
&#xD;
          -  Known or suspected malignancy&#xD;
&#xD;
          -  Non-English speaker&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faulkner Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>August 12, 2020</results_first_submitted>
  <results_first_submitted_qc>August 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2020</results_first_posted>
  <last_update_submitted>October 4, 2020</last_update_submitted>
  <last_update_submitted_qc>October 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Jon I. Einarsson</investigator_full_name>
    <investigator_title>Division Chair, Minimally Invasive Gynecology</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>Superior hypogastric plexus block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>July 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03283436/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Superior Hypogastric Plexus Block</title>
          <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
        </group>
        <group group_id="P2">
          <title>No Block</title>
          <description>Patients in the control arm will undergo the hysterectomy with no intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Superior Hypogastric Plexus Block</title>
          <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
        </group>
        <group group_id="B2">
          <title>No Block</title>
          <description>Patients in the control arm will undergo the hysterectomy with no intervention.</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="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" lower_limit="40" upper_limit="48"/>
                    <measurement group_id="B2" value="45" lower_limit="41" upper_limit="49"/>
                    <measurement group_id="B3" value="45" lower_limit="41" upper_limit="48"/>
                  </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="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </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>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White/Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.7" lower_limit="24.2" upper_limit="33.2"/>
                    <measurement group_id="B2" value="30.5" lower_limit="25.4" upper_limit="35.6"/>
                    <measurement group_id="B3" value="29.5" lower_limit="24.4" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gravidity</title>
          <units>Pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="0.5" upper_limit="3.5"/>
                    <measurement group_id="B2" value="2" lower_limit="0.5" upper_limit="3.5"/>
                    <measurement group_id="B3" value="2" lower_limit="0.5" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parity</title>
          <units>Pregnancies</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2" lower_limit="1.5" upper_limit="2.5"/>
                    <measurement group_id="B2" value="2" lower_limit="0.5" upper_limit="3.5"/>
                    <measurement group_id="B3" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indication for Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Fibroids</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal Uterine Bleeding</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pelvic pain</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain Scores</title>
        <description>The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.</description>
        <time_frame>Admission to recovery unit and every hour after for 2 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superior Hypogastric Plexus Block</title>
            <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
          </group>
          <group group_id="O2">
            <title>No Block</title>
            <description>Patients in the control arm will undergo the hysterectomy with no intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Scores</title>
          <description>The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="1.6" upper_limit="6.3"/>
                    <measurement group_id="O2" value="4.7" lower_limit="3.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Opioid Use</title>
        <description>Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.</description>
        <time_frame>Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superior Hypogastric Plexus Block</title>
            <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
          </group>
          <group group_id="O2">
            <title>No Block</title>
            <description>Patients in the control arm will undergo the hysterectomy with no intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Opioid Use</title>
          <description>Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.</description>
          <units>milligrams morphine equivalents</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>postoperative day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="-1.9" upper_limit="11.9"/>
                    <measurement group_id="O2" value="10.2" lower_limit="4" upper_limit="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-2.5" upper_limit="2.5"/>
                    <measurement group_id="O2" value="2.5" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1.3" upper_limit="1.3"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1.3" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0" lower_limit="-1.3" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Pain Scores</title>
        <description>Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.</description>
        <time_frame>Discharge to 1 week after surgery, assessed up to 1 week after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superior Hypogastric Plexus Block</title>
            <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
          </group>
          <group group_id="O2">
            <title>No Block</title>
            <description>Patients in the control arm will undergo the hysterectomy with no intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain Scores</title>
          <description>Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>postoperative day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2.3" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6" lower_limit="4.6" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="4.5" upper_limit="8.1"/>
                    <measurement group_id="O2" value="5.6" lower_limit="4.2" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3.6" upper_limit="7.5"/>
                    <measurement group_id="O2" value="5" lower_limit="3.9" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="2.4" upper_limit="5.8"/>
                    <measurement group_id="O2" value="4" lower_limit="2.6" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2.3" upper_limit="5.7"/>
                    <measurement group_id="O2" value="4" lower_limit="2.5" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.5" upper_limit="4.6"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2.3" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>postoperative day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="1.3" upper_limit="4.4"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.6" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>one month after surgery for each study participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Superior Hypogastric Plexus Block</title>
          <description>Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.&#xD;
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)</description>
        </group>
        <group group_id="E2">
          <title>No Block</title>
          <description>Patients in the control arm will undergo the hysterectomy with no intervention.</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jon Einarsson</name_or_title>
      <organization>Brigham and Women's Hospital</organization>
      <phone>617-525-8582</phone>
      <email>jeinarsson@partners.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283436
org study id: 2017P001804
nct id: NCT03283436
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The goal of this study is to assess the efficacy of a superior hypogastric plexus block
      (SHPB) for pain relief following a laparoscopic hysterectomy.
The objective of this study is to assess the efficacy of a SHPB for pain relief following
      laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and
      supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role
      in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB
      using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption
      following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid
      consumption will be collected from the Medication Administration Record by the nursing staff.
      The nursing staff will also be asked to complete a recovery worksheet that details the Visual
      Analog Scale pain score and opioid administration on admission to the recovery unit and every
      postoperative hour until six hours or the patient is discharged. Patients will also be asked
      to complete a daily diary for one week following the procedure, which details their pain
      level and daily opioid consumption. Patients will be followed for thirty days after surgery
      to assess for the occurrence of any postoperative complications. Detailed patient and
      procedure characteristics including age, race, body mass index, parity, surgical history,
      surgery indication, procedure type, and surgical approach will also be collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.
measure: Postoperative Pain Scores
time frame: Admission to recovery unit and every hour after for 2 hours
description: The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
measure: Postoperative Opioid Use
time frame: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
description: Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
measure: Postoperative Pain Scores
time frame: Discharge to 1 week after surgery, assessed up to 1 week after surgery
description: Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
arm group label: Superior hypogastric plexus block
arm group type: Experimental
description: Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
arm group label: No block
arm group type: No Intervention
description: Patients in the control arm will undergo the hysterectomy with no intervention.
intervention type: Drug
intervention name: Bupivacaine Hydrochloride 0.25% Injection Solution
description: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
arm group label: Superior hypogastric plexus block
other name: Bupivacaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Jon I. Einarsson
investigator title: Division Chair, Minimally Invasive Gynecology
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 