<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/NCT04440995</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0430</org_study_id>
    <nct_id>NCT04440995</nct_id>
  </id_info>
  <brief_title>The Effects of Perioperative PECS Block During Robotic Breast Surgery and Breast Reconstruction</brief_title>
  <official_title>The Effects of Perioperative PECS Block on Postoperative Pain Control During Robotic Breast Surgery and Breast Reconstruction - Double Blind Randomized Controlled Trial -</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in&#xD;
      nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and&#xD;
      postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate&#xD;
      the efficacy of intraoperative PECS block for postoperative analgesia after robot breast&#xD;
      surgery and immediate breast reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty patients were randomly allocated into two groups by computerised process, each&#xD;
      including 30 patients. PECS group (P) received general anesthesia and pectoral nerve&#xD;
      block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.&#xD;
      Control group(C) only received general anesthesia.&#xD;
&#xD;
      A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.&#xD;
&#xD;
      The Primary outcome measures total dose of fentanyl consumption during the postoperative 24&#xD;
      hours, and secondary outcome measures pain scores at rest and movement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">October 10, 2021</completion_date>
  <primary_completion_date type="Actual">October 10, 2021</primary_completion_date>
  <phase>N/A</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total dose of fentanyl consumption during the postoperative 24h</measure>
    <time_frame>after 24 hours postoperative period</time_frame>
    <description>To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>0 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>0.5 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>8 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at rest</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>0 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>0.5 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>8 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>a numeric rating score at movement</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>PECS block(P) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control(c) group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>only received general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pectoral nerve block</intervention_name>
    <description>Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block</description>
    <arm_group_label>PECS block(P) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 20years or older&#xD;
&#xD;
          2. Scheduled for robot-assisted nipple-sparing mastectomy with immediate gel implant or&#xD;
             tissue expander breast reconstruction&#xD;
&#xD;
          3. American Society of Anesthesiologists(ASA) physical status I and III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Emergency operation&#xD;
&#xD;
          2. Reoperation&#xD;
&#xD;
          3. Patients with local anesthetic allergy&#xD;
&#xD;
          4. Patients with coagulopathy&#xD;
&#xD;
          5. Patients on anticoagulants&#xD;
&#xD;
          6. Patients who cannot use patient controlled analgesia(PCA)&#xD;
&#xD;
          7. Patients with morbid obesity [body mass index (BMI) &gt;35 kg/m2]&#xD;
&#xD;
          8. Patients with history of uncontrolled hypertension (diastolic BP &gt;110mmHg) or DM&#xD;
&#xD;
          9. Patients with history of heart failure (unstable angina, congestive heart failure)&#xD;
&#xD;
         10. Patients with history of liver failure, renal failure, allergic to medicine&#xD;
&#xD;
         11. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral&#xD;
             ischemia)&#xD;
&#xD;
         12. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)&#xD;
&#xD;
         13. Patients who cannot read the consent form (examples: Illiterate, foreigner)&#xD;
&#xD;
         14. Patients who withdraw the consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sun Jun Bai, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast neoplasms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04440995
org study id: 4-2020-0430
nct id: NCT04440995
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pectoral nerve blocks (PECS blok) are used in postoperative analgesia after breast surgery in
      nowadays. Many studies shows that pectoral nerve blocks is effective for reducing pain and
      postoperative opioid consumption undergoing mastectomy. This study was planned to evaluate
      the efficacy of intraoperative PECS block for postoperative analgesia after robot breast
      surgery and immediate breast reconstruction.
Sixty patients were randomly allocated into two groups by computerised process, each
      including 30 patients. PECS group (P) received general anesthesia and pectoral nerve
      block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
      Control group(C) only received general anesthesia.

      A Patient -controlled analgesia(PCA) device provides fentanyl for postoperative pain control.

      The Primary outcome measures total dose of fentanyl consumption during the postoperative 24
      hours, and secondary outcome measures pain scores at rest and movement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Total dose of fentanyl consumption during the postoperative 24h
time frame: after 24 hours postoperative period
description: To evaluate the effect of PECS block undergoing robot-assisted nipple-sparing mastectomy (RANSM) with immediate breast reconstruction (IBR), total cumulative dose of fentanyl was measured for the first postoperative 24h
measure: a numeric rating score at rest
time frame: 0 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 0.5 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 1 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 2 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 4 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 6 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 8 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 12 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at rest
time frame: 24 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 0 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 0.5 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 1 hour after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 2 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 4 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 6 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 8 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 12 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
measure: a numeric rating score at movement
time frame: 24 hours after surgery
description: Secondary outcome measures were postoperative pain using numeric rating score (NRS, 0-10; 0=no pain and 10=worst imaginable pain)
arm group label: PECS block(P) group
arm group type: Experimental
description: PECS group (P) received general anesthesia and pectoral nerve block(PECS block) with 025% ropivacaine after surgical resection of breast by operator.
arm group label: Control(c) group
arm group type: No Intervention
description: only received general anesthesia
intervention type: Procedure
intervention name: pectoral nerve block
description: Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block
arm group label: PECS block(P) group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sun Jun Bai, Ph.D
role: Study Director
affiliation: Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No