<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/NCT04474366</url>
  </required_header>
  <id_info>
    <org_study_id>19-28267</org_study_id>
    <nct_id>NCT04474366</nct_id>
  </id_info>
  <brief_title>The Effect of Pectoral Blocks on Perioperative Pain in Gender Affirmation Top Surgery</brief_title>
  <official_title>The Effect of Pectoral Blocks on Perioperative Pain in Simple Mastectomy and Breast Reduction in Gender Affirmation Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      Despite recent advancements with regional and local anesthesia, postoperative pain continues&#xD;
      to be a major concern for patients undergoing breast surgery. Opioids, often in combination&#xD;
      with NSAIDS and/or gabapentioids, have been the main pharmacologic pain control strategy in&#xD;
      the postoperative period. The pectoral nerve block is a regional anesthetic technique, which&#xD;
      is effective at providing postoperative anesthesia in breast surgeries. However, this has&#xD;
      only been studied in oncologic-related breast operations. It is our aim to study the effects&#xD;
      of pectoral regional nerve blocks in patients undergoing breast reduction for gender&#xD;
      affirmation. The overall goal is to establish an effective pain control regimen utilizing&#xD;
      regional anesthetic techniques in this patient population. The specific objective of this&#xD;
      proposal is to evaluate the effectiveness of these blocks on perioperative and postoperative&#xD;
      analgesia. The hypothesis is that participants undergoing gender-affirmation breast surgery&#xD;
      who receive a pectoral nerve block will have less perioperative and postoperative pain as&#xD;
      well as reduced opioid consumption compared to those receiving a placebo. Participants who&#xD;
      are undergoing gender affirmation breast reduction surgery will be randomized to either&#xD;
      receive a preoperative nerve block or to receive a placebo. Intraoperative and postoperative&#xD;
      opioid requirements will be compared in addition to post-operative pain scores. Participants&#xD;
      will be asked to fill out a pain diary during their first week postoperatively. They will&#xD;
      also be asked to document if, and when, narcotic pain medication was required for pain&#xD;
      control. The two groups will be compared to determine if there was any difference in pain&#xD;
      scores as well as narcotic medication requirements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will be seen in clinic with the attending surgeon anywhere from two weeks to&#xD;
      a few months prior to the date of surgery. Participants will also have a pre-op visit with&#xD;
      anesthesia a few weeks before surgery. They will undergo a standard anesthesia preoperative&#xD;
      evaluation, which will include a medical chart review, physical exam, and appropriate&#xD;
      laboratory studies. The preoperative evaluation will be identical for those participating in&#xD;
      the study and those who do not. If no contraindications to the Pectoralis Nerve Block (PECS I&#xD;
      and II block) are identified by the surgeon and/or anesthesiologist, participants will be&#xD;
      approved to participate. The participants will be introduced to the study either during their&#xD;
      clinic visit prior to surgery or over the telephone a few days prior to surgery. All&#xD;
      questions will be answered by one of the study investigators. A study consent will be&#xD;
      obtained from the participants and they will then will be randomized into either control&#xD;
      (sham block) or experimental (PECS I and II block) group.&#xD;
&#xD;
      On the day of surgery, as per standard of care, each participant will undergo a general&#xD;
      anesthetic in the same manner with conventional perioperative management. During induction of&#xD;
      anesthesia, up to 2mg of midazolam and/or up to 100mcg of fentanyl will be given. The above&#xD;
      protocol will be followed regardless of study participation and study group (if&#xD;
      participating). After induction of anesthesia, the nerve blocks, or control blocks, will be&#xD;
      performed. The regional anesthesia team will be involved in all patients, whether in the&#xD;
      control or intervention group. All patients will be come and go regardless of group.&#xD;
&#xD;
      Group 1 (control) will receive an injection of 20ml of saline between the pectoralis minor&#xD;
      and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and&#xD;
      pectoralis major muscles bilaterally.&#xD;
&#xD;
      Group 2 (treatment) will receive an injection of 20ml of 0.2% Ropivacaine between the&#xD;
      pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine&#xD;
      between the pectoralis minor and pectoralis major muscles bilaterally. (Not to exceed 225mg&#xD;
      or 3.5mg/kg).&#xD;
&#xD;
      PECS I and II Block Technique: Performed in the supine position with the arms abducted 90&#xD;
      degrees at the shoulder. Using an ultrasound transducer in the parasagittal plane, the&#xD;
      axillary artery and vein are identified just inferior to clavicle and medial to coracoid&#xD;
      process. Additionally, the 2nd rib is identified and the transducer is slid inferiorly until&#xD;
      the 3rd and 4th rib are identified. At this point the pectoralis major, minor, and serratus&#xD;
      anterior muscles are seen. Then the block needle is inserted through the skin and advanced&#xD;
      into the fascial plane between pectoralis minor and serratus anterior muscles. After negative&#xD;
      aspiration, the anesthetic is injected into the plane watching for hydrodissection of the&#xD;
      muscles. A total volume of 20ml is injected. Then the needed is withdrawn until the tip is&#xD;
      located in the fascial plane between the pectoralis major and minor muscles. 10ml of&#xD;
      anesthetic is injected into this plane.&#xD;
&#xD;
      General anesthesia is maintained in the standard fashion. The anesthesiologist will&#xD;
      administer Fentanyl as he or she feels necessary during the operation. Post operatively, in&#xD;
      the PACU, participants will be given IV hydromorphone as needed for pain. Pain scales will be&#xD;
      documented at set time points post operatively and participants will be given pain diaries to&#xD;
      document these pain scores as well as their opioid consumption. All patients will be sent&#xD;
      home with a prescription for 20 tablets of Norco 5mg/325mg. Participants will be asked to&#xD;
      document their pain scores at the following post op time points: 1 hour, 2 hours, 4 hours, 6&#xD;
      hours, 12 hours, 24 hours, 48 hours, 72 hours, 1 week. Participants will return their pain&#xD;
      diaries at the 1 week post operative visit. This visit is a standard of care follow up visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 2022</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Post Operative Pain Scores</measure>
    <time_frame>1 week post operative</time_frame>
    <description>Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Intra Operative Narcotic Requirements</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of Post Operative Narcotic Requirements</measure>
    <time_frame>1 week post operative</time_frame>
    <description>Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Gender Dysphoria</condition>
  <condition>Opioid Use</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine 0.2% Injectable Solution</intervention_name>
    <description>Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</description>
    <arm_group_label>Ropivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline (0.9%)</intervention_name>
    <description>Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class I-III&#xD;
&#xD;
          -  Ages 18-65&#xD;
&#xD;
          -  Undergoing gender confirmation breast reduction surgery by a single surgeon at a&#xD;
             single center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous breast surgeries&#xD;
&#xD;
          -  Current breast cancer or history of treatment for breast cancer&#xD;
&#xD;
          -  Current chronic pain syndromes&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Infection at the injection site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.</citation>
    <PMID>25376971</PMID>
  </reference>
  <reference>
    <citation>M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.</citation>
    <PMID>29241077</PMID>
  </reference>
  <reference>
    <citation>Benotsch EG, Zimmerman R, Cathers L, McNulty S, Pierce J, Heck T, Perrin PB, Snipes D. Non-medical use of prescription drugs, polysubstance use, and mental health in transgender adults. Drug Alcohol Depend. 2013 Sep 1;132(1-2):391-4. doi: 10.1016/j.drugalcdep.2013.02.027. Epub 2013 Mar 17.</citation>
    <PMID>23510637</PMID>
  </reference>
  <reference>
    <citation>Day JK, Fish JN, Perez-Brumer A, Hatzenbuehler ML, Russell ST. Transgender Youth Substance Use Disparities: Results From a Population-Based Sample. J Adolesc Health. 2017 Dec;61(6):729-735. doi: 10.1016/j.jadohealth.2017.06.024. Epub 2017 Sep 21.</citation>
    <PMID>28942238</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <results_first_submitted>February 7, 2023</results_first_submitted>
  <results_first_submitted_qc>June 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2023</results_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Gender Dysphoria</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data. For any purpose.</ipd_access_criteria>
  </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>February 4, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT04474366/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Saline</title>
          <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
        </group>
        <group group_id="P2">
          <title>Ropivacaine</title>
          <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Saline</title>
          <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
        </group>
        <group group_id="B2">
          <title>Ropivacaine</title>
          <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</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="21"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.5" spread="8.7"/>
                    <measurement group_id="B2" value="27.1" spread="7.2"/>
                    <measurement group_id="B3" value="27.3" spread="7.9"/>
                  </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="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </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="21"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Comparison of Post Operative Pain Scores</title>
        <description>Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.</description>
        <time_frame>1 week post operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Saline</title>
            <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine</title>
            <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Post Operative Pain Scores</title>
          <description>Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.8"/>
                    <measurement group_id="O2" value="3.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Intra Operative Narcotic Requirements</title>
        <description>Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.</description>
        <time_frame>Intraoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Saline</title>
            <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine</title>
            <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Intra Operative Narcotic Requirements</title>
          <description>Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.</description>
          <units>Morphine Milligram Equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" spread="3.5"/>
                    <measurement group_id="O2" value="9.8" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of Post Operative Narcotic Requirements</title>
        <description>Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.</description>
        <time_frame>1 week post operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Saline</title>
            <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine</title>
            <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of Post Operative Narcotic Requirements</title>
          <description>Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.</description>
          <units>Morphine Milligram 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="21"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="15" upper_limit="65"/>
                    <measurement group_id="O2" value="37.5" lower_limit="15.4" upper_limit="71.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.72</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Subjects were followed post operatively at designated time points after the surgery. These included 1 week, 2 weeks, 6 weeks, 3 months, and 6 months. Any adverse event encountered in this time frame was reported</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Saline</title>
          <description>Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.&#xD;
Saline (0.9%): Saline injection as sham block in identical fashion as Pectoralis Nerve Block</description>
        </group>
        <group group_id="E2">
          <title>Ropivacaine</title>
          <description>Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).&#xD;
Ropivacaine 0.2% Injectable Solution: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </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>Esther Kim</name_or_title>
      <organization>University of California, San Francisco</organization>
      <phone>415-353-9392</phone>
      <email>Esther.kim@ucsf.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/NCT04474366
org study id: 19-28267
nct id: NCT04474366
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Despite recent advancements with regional and local anesthesia, postoperative pain continues
      to be a major concern for patients undergoing breast surgery. Opioids, often in combination
      with NSAIDS and/or gabapentioids, have been the main pharmacologic pain control strategy in
      the postoperative period. The pectoral nerve block is a regional anesthetic technique, which
      is effective at providing postoperative anesthesia in breast surgeries. However, this has
      only been studied in oncologic-related breast operations. It is our aim to study the effects
      of pectoral regional nerve blocks in patients undergoing breast reduction for gender
      affirmation. The overall goal is to establish an effective pain control regimen utilizing
      regional anesthetic techniques in this patient population. The specific objective of this
      proposal is to evaluate the effectiveness of these blocks on perioperative and postoperative
      analgesia. The hypothesis is that participants undergoing gender-affirmation breast surgery
      who receive a pectoral nerve block will have less perioperative and postoperative pain as
      well as reduced opioid consumption compared to those receiving a placebo. Participants who
      are undergoing gender affirmation breast reduction surgery will be randomized to either
      receive a preoperative nerve block or to receive a placebo. Intraoperative and postoperative
      opioid requirements will be compared in addition to post-operative pain scores. Participants
      will be asked to fill out a pain diary during their first week postoperatively. They will
      also be asked to document if, and when, narcotic pain medication was required for pain
      control. The two groups will be compared to determine if there was any difference in pain
      scores as well as narcotic medication requirements.
All participants will be seen in clinic with the attending surgeon anywhere from two weeks to
      a few months prior to the date of surgery. Participants will also have a pre-op visit with
      anesthesia a few weeks before surgery. They will undergo a standard anesthesia preoperative
      evaluation, which will include a medical chart review, physical exam, and appropriate
      laboratory studies. The preoperative evaluation will be identical for those participating in
      the study and those who do not. If no contraindications to the Pectoralis Nerve Block (PECS I
      and II block) are identified by the surgeon and/or anesthesiologist, participants will be
      approved to participate. The participants will be introduced to the study either during their
      clinic visit prior to surgery or over the telephone a few days prior to surgery. All
      questions will be answered by one of the study investigators. A study consent will be
      obtained from the participants and they will then will be randomized into either control
      (sham block) or experimental (PECS I and II block) group.

      On the day of surgery, as per standard of care, each participant will undergo a general
      anesthetic in the same manner with conventional perioperative management. During induction of
      anesthesia, up to 2mg of midazolam and/or up to 100mcg of fentanyl will be given. The above
      protocol will be followed regardless of study participation and study group (if
      participating). After induction of anesthesia, the nerve blocks, or control blocks, will be
      performed. The regional anesthesia team will be involved in all patients, whether in the
      control or intervention group. All patients will be come and go regardless of group.

      Group 1 (control) will receive an injection of 20ml of saline between the pectoralis minor
      and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and
      pectoralis major muscles bilaterally.

      Group 2 (treatment) will receive an injection of 20ml of 0.2% Ropivacaine between the
      pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine
      between the pectoralis minor and pectoralis major muscles bilaterally. (Not to exceed 225mg
      or 3.5mg/kg).

      PECS I and II Block Technique: Performed in the supine position with the arms abducted 90
      degrees at the shoulder. Using an ultrasound transducer in the parasagittal plane, the
      axillary artery and vein are identified just inferior to clavicle and medial to coracoid
      process. Additionally, the 2nd rib is identified and the transducer is slid inferiorly until
      the 3rd and 4th rib are identified. At this point the pectoralis major, minor, and serratus
      anterior muscles are seen. Then the block needle is inserted through the skin and advanced
      into the fascial plane between pectoralis minor and serratus anterior muscles. After negative
      aspiration, the anesthetic is injected into the plane watching for hydrodissection of the
      muscles. A total volume of 20ml is injected. Then the needed is withdrawn until the tip is
      located in the fascial plane between the pectoralis major and minor muscles. 10ml of
      anesthetic is injected into this plane.

      General anesthesia is maintained in the standard fashion. The anesthesiologist will
      administer Fentanyl as he or she feels necessary during the operation. Post operatively, in
      the PACU, participants will be given IV hydromorphone as needed for pain. Pain scales will be
      documented at set time points post operatively and participants will be given pain diaries to
      document these pain scores as well as their opioid consumption. All patients will be sent
      home with a prescription for 20 tablets of Norco 5mg/325mg. Participants will be asked to
      document their pain scores at the following post op time points: 1 hour, 2 hours, 4 hours, 6
      hours, 12 hours, 24 hours, 48 hours, 72 hours, 1 week. Participants will return their pain
      diaries at the 1 week post operative visit. This visit is a standard of care follow up visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Comparison of Post Operative Pain Scores
time frame: 1 week post operative
description: Participant recorded Numerical Rating Scale (NRS) pain scores post operatively. Scale ranges from 0 to 10. 0 represents no pain at all. 10 represents most severe pain.
measure: Comparison of Intra Operative Narcotic Requirements
time frame: Intraoperative
description: Intraoperative narcotic administration will be compared. Narcotic administration will be acquired through chart review. Total dose of IV hydromorphone intraoperatively will be collected.
measure: Comparison of Post Operative Narcotic Requirements
time frame: 1 week post operative
description: Self reported narcotic intake postoperatively. Number of pills taken will be recorded. Each group's number of pills will be averaged.
arm group label: Saline
arm group type: Sham Comparator
description: Control group will receive an injection of 20ml of saline between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of saline between the pectoralis minor and pectoralis major muscles bilaterally.
arm group label: Ropivacaine
arm group type: Experimental
description: Intervention group will receive an injection of 20ml of 0.2% Ropivacaine between the pectoralis minor and serratus anterior muscles bilaterally and 10ml of 0.2% Ropivacaine between the pectoralis minor and pectoralis major muscles bilaterally (Not to exceed 225mg or 3.5mg/kg).
intervention type: Drug
intervention name: Ropivacaine 0.2% Injectable Solution
description: Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
arm group label: Ropivacaine
intervention type: Other
intervention name: Saline (0.9%)
description: Saline injection as sham block in identical fashion as Pectoralis Nerve Block
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Esther Kim, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PMID: 25376971
citation: M N, Pandey RK, Sharma A, Darlong V, Punj J, Sinha R, Singh PM, Hamshi N, Garg R, Chandralekha C, Srivastava A. Pectoral nerve blocks to improve analgesia after breast cancer surgery: A prospective, randomized and controlled trial. J Clin Anesth. 2018 Mar;45:12-17. doi: 10.1016/j.jclinane.2017.11.027. Epub 2017 Dec 11.
PMID: 29241077
citation: Benotsch EG, Zimmerman R, Cathers L, McNulty S, Pierce J, Heck T, Perrin PB, Snipes D. Non-medical use of prescription drugs, polysubstance use, and mental health in transgender adults. Drug Alcohol Depend. 2013 Sep 1;132(1-2):391-4. doi: 10.1016/j.drugalcdep.2013.02.027. Epub 2013 Mar 17.
PMID: 23510637
citation: Day JK, Fish JN, Perez-Brumer A, Hatzenbuehler ML, Russell ST. Transgender Youth Substance Use Disparities: Results From a Population-Based Sample. J Adolesc Health. 2017 Dec;61(6):729-735. doi: 10.1016/j.jadohealth.2017.06.024. Epub 2017 Sep 21.
PMID: 28942238
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Gender Dysphoria
mesh term: Ropivacaine
sharing ipd: Yes
ipd description: All of the individual participant data collected during the trial, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Anyone who wishes to access the data. For any purpose.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 