<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/NCT04429022</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004549</org_study_id>
    <nct_id>NCT04429022</nct_id>
  </id_info>
  <brief_title>Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy</brief_title>
  <acronym>RA-TLH</acronym>
  <official_title>Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hysterectomy is the most common major gynecologic surgery performed in the US and is&#xD;
      performed for a variety of indications including malignancy, pelvic mass, endometriosis,&#xD;
      leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control&#xD;
      post-operatively is opioid-based however in light of the opioid epidemic, a transition to&#xD;
      non-opioid pain medication regimens is desired by both physicians and patients alike. The&#xD;
      goal of this study is to develop a multimodal non-opioid pain medication regimen that&#xD;
      minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy.&#xD;
      Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm&#xD;
      from November, 2020 to November, 2022. Included in our treatment protocol is paracervical&#xD;
      block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and&#xD;
      acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use&#xD;
      will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering&#xD;
      in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain&#xD;
      scores will additionally be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material and Methods:&#xD;
&#xD;
      This is a prospective cohort study with historical controls. Cases of those receiving a&#xD;
      non-opioid multimodal pain regimen will be compared to historical controls of those receiving&#xD;
      a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic&#xD;
      hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325&#xD;
      grams will be included in this study. Multimodal pain regimen will include the following:&#xD;
&#xD;
      Protocol:&#xD;
&#xD;
      Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area)&#xD;
&#xD;
        -  Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area)&#xD;
&#xD;
      Intra-Op:&#xD;
&#xD;
        -  Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point)&#xD;
           for total of 20mL&#xD;
&#xD;
        -  Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
&#xD;
        -  Will operate at &lt;15mmHg intra-abdominal pressure with goal of &lt;12mmHg&#xD;
&#xD;
        -  At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
&#xD;
      Post-Op:&#xD;
&#xD;
        -  Gabapentin 300mg PO BID for 7 days&#xD;
&#xD;
        -  Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
&#xD;
        -  Celecoxib 200mg PO q 12h x 7d&#xD;
&#xD;
        -  Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME)&#xD;
&#xD;
        -  if patient did not use any opioids postoperatively while inpatient, will not prescribe&#xD;
           opioid medication upon discharge&#xD;
&#xD;
        -  Also include standard post-op medications such as zofran, reglan, mylicon…&#xD;
&#xD;
      Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes&#xD;
      include pain scores as rated subjectively by the patient, length of stay in hours and whether&#xD;
      the patient returns to the clinic or emergency department due to post operative pain within a&#xD;
      2 week period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Prospective cohort with retrospective controls</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)</measure>
    <time_frame>0-3 hours after surgery</time_frame>
    <description>Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Opioid Pain Medications Required Through 3-24h Post op in MME</measure>
    <time_frame>3-24 hours after surgery</time_frame>
    <description>Total opioid pain medications required through 3-24h post op in MME</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>3-24 hours after surgery</time_frame>
    <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>0-3 hours after surgery</time_frame>
    <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay in Hours</measure>
    <time_frame>0- 240 hours</time_frame>
    <description>Length of stay in hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period</measure>
    <time_frame>0-14 days</time_frame>
    <description>Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative Time</measure>
    <time_frame>0-300 minutes</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Blood Loss</measure>
    <time_frame>0-300 minutes</time_frame>
    <description>milliliters (mL)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Prospective cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op</description>
    <arm_group_label>Prospective cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op</description>
    <arm_group_label>Prospective cohort</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Celecoxib 200mg PO q 12h x 7d post op</description>
    <arm_group_label>Prospective cohort</arm_group_label>
    <other_name>Celebrex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>30mg IV once at end of hysterectomy procedure</description>
    <arm_group_label>Prospective cohort</arm_group_label>
    <other_name>Toradol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paracervical block with ropivacaine</intervention_name>
    <description>0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL</description>
    <arm_group_label>Prospective cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites</intervention_name>
    <description>0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total</description>
    <arm_group_label>Prospective cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydromorphone</intervention_name>
    <description>1mg IV PRN q3h, post op, while inpatient</description>
    <arm_group_label>Historical Control</arm_group_label>
    <arm_group_label>Prospective cohort</arm_group_label>
    <other_name>Dilaudid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>To be discharged home with: 12 tabs of 5mg PRN q4h</description>
    <arm_group_label>Prospective cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without&#xD;
             bilateral salpingo-oophorectomy&#xD;
&#xD;
          -  Uterine weight ≤325 grams&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)&#xD;
&#xD;
          -  current opioid prescription&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Andres, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Millard Fillmore Suburban Hospital</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Adajar, A. (2018). 73: Eliminating post-operative narcotic use after mini-laparoscopic hysterectomy: Effectiveness of a multimodal pain management regimen adopted into clinical practice. American Journal of Obstetrics and Gynecology, 218(2), S937-S938. https://doi.org/10.1016/j.ajog.2017.12.092</citation>
  </reference>
  <reference>
    <citation>Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.</citation>
    <PMID>28043841</PMID>
  </reference>
  <reference>
    <citation>Chopra, V., Kown, D., &amp; Sangha, R. (2018). Decreasing Postoperative Narcotic Use for Patients Undergoing Hysterectomy. Journal of Minimally Invasive Gynecology, 25(7), S194-S194. https://doi.org/10.1016/j.jmig.2018.09.526</citation>
  </reference>
  <reference>
    <citation>Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.</citation>
    <PMID>30646274</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>April 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>May 10, 2023</results_first_submitted>
  <results_first_submitted_qc>July 28, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2023</results_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Sarah Andres, D.O.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hysterectomy</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>Acetaminophen</mesh_term>
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Hydromorphone</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be available to other researchers</ipd_description>
  </patient_data>
  <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>May 10, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04429022/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04429022/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>For the intervention arm, patients were recruited from November 24, 2020 to May 24, 2022. Data for the retrospective controls who underwent their hysterectomy from 11/27/2018 to 12/12/2019, was obtained via chart review. This was a prospective cohort study with retrospective controls. To allow for adjustment to this new protocol, 11 months were allocated to the institution and staff, prior to enrolling patients in the intervention arm.</recruitment_details>
      <pre_assignment_details>49 patients were analyzed as 18 of 28 intervention arm participants did not receive the intervention or their care required deviation from the from study protocol (e.g., no minimally invasive hysterectomy due to laparotomy, no paracervical block due to indocyanine green injection for lymph node mapping, no postoperative protocol medications due to limited resources and logistical issues). One of the 40 control participants was excluded due to uterine weight exceeding the study protocol range.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Prospective Cohort</title>
          <description>Pre-Op:&#xD;
Gabapentin 600mg PO x 1 and&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with 0.5% ropivacaine; 10 mL bilaterally (2 points), total of 20mL&#xD;
0.5% ropivacaine subcutaneous injection at all laparoscopic port sites; another 10mL&#xD;
Operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME). If patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
        </group>
        <group group_id="P2">
          <title>Historical Control</title>
          <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prospective Cohort</title>
          <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
        </group>
        <group group_id="B2">
          <title>Historical Control</title>
          <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</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="10"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.60" lower_limit="32" upper_limit="57"/>
                    <measurement group_id="B2" value="44.13" lower_limit="25" upper_limit="67"/>
                    <measurement group_id="B3" value="44.37" lower_limit="25" upper_limit="67"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="49"/>
                  </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 and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="39"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)</title>
        <description>Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)</description>
        <time_frame>0-3 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)</title>
          <description>Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)</description>
          <units>morphine milligram equivalents (MME)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="5.32" lower_limit="0" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Opioid Pain Medications Required Through 3-24h Post op in MME</title>
        <description>Total opioid pain medications required through 3-24h post op in MME</description>
        <time_frame>3-24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Pain Medications Required Through 3-24h Post op in MME</title>
          <description>Total opioid pain medications required through 3-24h post op in MME</description>
          <units>morphine milligram equivalents (MME)</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".20" lower_limit="0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="12.27" lower_limit="0" upper_limit="52.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores</title>
        <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
        <time_frame>3-24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores</title>
          <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" lower_limit="0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="5.43" lower_limit="0" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores</title>
        <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
        <time_frame>0-3 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores</title>
          <description>Subjective, Score 0-10 with 0 being no pain and 10 being severe pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.82" lower_limit="0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="5.13" lower_limit="0" upper_limit="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay in Hours</title>
        <description>Length of stay in hours</description>
        <time_frame>0- 240 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in Hours</title>
          <description>Length of stay in hours</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.05" lower_limit="6.0" upper_limit="34.0"/>
                    <measurement group_id="O2" value="35.82" lower_limit="10.0" upper_limit="239.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period</title>
        <description>Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period</description>
        <time_frame>0-14 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period</title>
          <description>Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period</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="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Operative Time</title>
        <description>minutes</description>
        <time_frame>0-300 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Operative Time</title>
          <description>minutes</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.80" lower_limit="90" upper_limit="179"/>
                    <measurement group_id="O2" value="139.69" lower_limit="73" upper_limit="262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Estimated Blood Loss</title>
        <description>milliliters (mL)</description>
        <time_frame>0-300 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prospective Cohort</title>
            <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
          </group>
          <group group_id="O2">
            <title>Historical Control</title>
            <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</description>
          </group>
        </group_list>
        <measure>
          <title>Estimated Blood Loss</title>
          <description>milliliters (mL)</description>
          <units>milliliters</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.50" lower_limit="10" upper_limit="150"/>
                    <measurement group_id="O2" value="58.46" lower_limit="5" upper_limit="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>14 days</time_frame>
      <desc>All participants were assessed for adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Prospective Cohort</title>
          <description>Pre-Op:&#xD;
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)&#xD;
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)&#xD;
Intra-Op:&#xD;
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL&#xD;
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL&#xD;
Will operate at &lt;15mmHg intra-abdominal pressure, with goal of &lt;12mmHg&#xD;
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1&#xD;
Post-Op:&#xD;
Gabapentin 300mg PO BID for 7 days&#xD;
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN&#xD;
Celecoxib 200mg PO q 12h x 7d&#xD;
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge</description>
        </group>
        <group group_id="E2">
          <title>Historical Control</title>
          <description>Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge&#xD;
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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 Sarah Andres, PI</name_or_title>
      <organization>University at Buffalo</organization>
      <phone>7163230631</phone>
      <email>seandres@buffalo.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/NCT04429022
org study id: STUDY00004549
nct id: NCT04429022
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Hysterectomy is the most common major gynecologic surgery performed in the US and is
      performed for a variety of indications including malignancy, pelvic mass, endometriosis,
      leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control
      post-operatively is opioid-based however in light of the opioid epidemic, a transition to
      non-opioid pain medication regimens is desired by both physicians and patients alike. The
      goal of this study is to develop a multimodal non-opioid pain medication regimen that
      minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy.
      Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm
      from November, 2020 to November, 2022. Included in our treatment protocol is paracervical
      block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and
      acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use
      will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering
      in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain
      scores will additionally be measured.
Material and Methods:

      This is a prospective cohort study with historical controls. Cases of those receiving a
      non-opioid multimodal pain regimen will be compared to historical controls of those receiving
      a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic
      hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325
      grams will be included in this study. Multimodal pain regimen will include the following:

      Protocol:

      Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area)

        -  Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area)

      Intra-Op:

        -  Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point)
           for total of 20mL

        -  Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL

        -  Will operate at <15mmHg intra-abdominal pressure with goal of <12mmHg

        -  At end of procedure during closure of fascia, give 30mg ketorolac IV x 1

      Post-Op:

        -  Gabapentin 300mg PO BID for 7 days

        -  Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN

        -  Celecoxib 200mg PO q 12h x 7d

        -  Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME)

        -  if patient did not use any opioids postoperatively while inpatient, will not prescribe
           opioid medication upon discharge

        -  Also include standard post-op medications such as zofran, reglan, mylicon…

      Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes
      include pain scores as rated subjectively by the patient, length of stay in hours and whether
      the patient returns to the clinic or emergency department due to post operative pain within a
      2 week period.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Prospective cohort with retrospective controls
primary purpose: Treatment
masking: None (Open Label)
measure: Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
time frame: 0-3 hours after surgery
description: Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
measure: Total Opioid Pain Medications Required Through 3-24h Post op in MME
time frame: 3-24 hours after surgery
description: Total opioid pain medications required through 3-24h post op in MME
measure: Pain Scores
time frame: 3-24 hours after surgery
description: Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
measure: Pain Scores
time frame: 0-3 hours after surgery
description: Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
measure: Length of Stay in Hours
time frame: 0- 240 hours
description: Length of stay in hours
measure: Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
time frame: 0-14 days
description: Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period
measure: Operative Time
time frame: 0-300 minutes
description: minutes
measure: Estimated Blood Loss
time frame: 0-300 minutes
description: milliliters (mL)
arm group label: Prospective cohort
arm group type: Experimental
description: Pre-Op:
Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
Will operate at <15mmHg intra-abdominal pressure, with goal of <12mmHg
At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
Gabapentin 300mg PO BID for 7 days
Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
Celecoxib 200mg PO q 12h x 7d
Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge
arm group label: Historical Control
arm group type: Active Comparator
description: Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
intervention type: Drug
intervention name: Gabapentin
description: 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
arm group label: Prospective cohort
intervention type: Drug
intervention name: Acetaminophen
description: Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
arm group label: Prospective cohort
other name: Tylenol
intervention type: Drug
intervention name: Celecoxib
description: Celecoxib 200mg PO q 12h x 7d post op
arm group label: Prospective cohort
other name: Celebrex
intervention type: Drug
intervention name: Ketorolac
description: 30mg IV once at end of hysterectomy procedure
arm group label: Prospective cohort
other name: Toradol
intervention type: Procedure
intervention name: Paracervical block with ropivacaine
description: 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
arm group label: Prospective cohort
intervention type: Procedure
intervention name: Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites
description: 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
arm group label: Prospective cohort
intervention type: Drug
intervention name: Hydromorphone
description: 1mg IV PRN q3h, post op, while inpatient
arm group label: Historical Control
arm group label: Prospective cohort
other name: Dilaudid
intervention type: Drug
intervention name: Oxycodone
description: To be discharged home with: 12 tabs of 5mg PRN q4h
arm group label: Prospective cohort
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Andres, D.O.
role: Principal Investigator
affiliation: University at Buffalo
facility: 
country: United States
citation: Adajar, A. (2018). 73: Eliminating post-operative narcotic use after mini-laparoscopic hysterectomy: Effectiveness of a multimodal pain management regimen adopted into clinical practice. American Journal of Obstetrics and Gynecology, 218(2), S937-S938. https://doi.org/10.1016/j.ajog.2017.12.092
citation: Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
PMID: 28043841
citation: Chopra, V., Kown, D., & Sangha, R. (2018). Decreasing Postoperative Narcotic Use for Patients Undergoing Hysterectomy. Journal of Minimally Invasive Gynecology, 25(7), S194-S194. https://doi.org/10.1016/j.jmig.2018.09.526
citation: Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.
PMID: 30646274
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Sarah Andres, D.O.
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Acetaminophen
mesh term: Celecoxib
mesh term: Ketorolac
mesh term: Oxycodone
mesh term: Gabapentin
mesh term: Hydromorphone
mesh term: Ropivacaine
mesh term: Anesthetics, Local
mesh term: Anesthetics
sharing ipd: No
ipd description: IPD will not be available to other researchers
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 