xml: <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/NCT06019325</url>
    </required_header>
    <id_info>
      <org_study_id>230022</org_study_id>
      <nct_id>NCT06019325</nct_id>
    </id_info>
    <brief_title>Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy</brief_title>
    <official_title>The Effect of Single Shot Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muğla Sıtkı Koçman University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Muğla Sıtkı Koçman 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>
        Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves&#xD;
        between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute&#xD;
        pain following breast surgeries. However, it's effect on chronic pain has not been evaluated&#xD;
        yet. The primary hypothesis of the study is that the incidence of chronic pain of the&#xD;
        patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery&#xD;
        will be lower than the patients who will receive no block intervention at the postoperative&#xD;
        3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who&#xD;
        will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower&#xD;
        than the patients who will receive no block intervention at the postoperative 6th month. An&#xD;
        other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group&#xD;
        than control group at the postoperative 3rd and the 6th months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is designed as a prospective, double-blinded, randomize controlled study. The&#xD;
        patients who will undergo mastectomy surgery with or without axillary dissection will be&#xD;
        included in the study. Anesthesia will be inducted with intravenous (iv) thiopental 5 mg/kg,&#xD;
        fentanyl 2 mcg/kg and rocuronium bromide 0.6 mg/kg. Following intubation, patients will be&#xD;
        allocated into two groups according to a randomization table created by a professional&#xD;
        statistician. In the study group, patients will receive a single shot Rhomboid Intercostal&#xD;
        Block (RIB) with 30 milliliters of %0.25 bupivacaine and in the control group no block&#xD;
        procedure will be performed. All patients will receive a standard analgesia protocol which&#xD;
        will include an intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv&#xD;
        tramadol 1 mg/kg 15 minutes prior to the end of the surgery. Postoperative pain intensity of&#xD;
        the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges&#xD;
        between 0 (no pain) and 10 (the worst pain that a person can stand). Pain scores of the&#xD;
        patients will be recorded at the postoperative 15. and 30. min in the recovery room and if&#xD;
        the NRS score is 4 or more, iv fentanyl 1 mcg/kg will be applied. At the surgical ward, pain&#xD;
        scores will be evaluated at the postoperative 1st, 2nd, 6th, 12th and 24th hours and if the&#xD;
        NRS score is 4 or more, iv tramadol 50 mg will be applied as rescue analgesia. Opioid&#xD;
        consumptions of the patients will be recorded at the postoperative 24th hour. At the&#xD;
        postoperative 3. and 6. months, a pain doctor will evaluate all patients by using Brief Pain&#xD;
        Inventory Short Form (BPI-SF) and Douleur Neuropathique 4 (DN4) questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 7, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <intervention_model_description>Prospective, randomized, controlled study</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>The patients will be under general anesthesia and will not be aware if they receive a block procedure or not.&#xD;
  The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups, but she will not involve in data collection.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>3rd month chronic pain</measure>
      <time_frame>At the postoperative 3. month</time_frame>
      <description>The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>6th month chronic pain</measure>
      <time_frame>At the postoperative 6. month</time_frame>
      <description>The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 6th month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Secondary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 6th month.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3rd month total Brief Pain Inventory Short Form Score</measure>
      <time_frame>At the postoperative 3. month</time_frame>
      <description>Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 3rd month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 3rd month.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6th month total Brief Pain Inventory Short Form Score</measure>
      <time_frame>At the postoperative 6. month</time_frame>
      <description>Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 6th month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 6th month.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3rd month neuropathic pain</measure>
      <time_frame>At the postoperative 3. month</time_frame>
      <description>The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 5th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6th month neuropathic pain</measure>
      <time_frame>At the postoperative 6. month</time_frame>
      <description>The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 6th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups at the postoperative 6th month.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>acute pain</measure>
      <time_frame>Postoperative 15. minute, 30. minute, 1.hour, 2nd hour, 6th hour, 12th hour, 24th hour</time_frame>
      <description>Postoperative acute pain of the patients will be evaluated by using Numerical Rating Scale which ranges between 0 point (no pain) and 10 points (worst pain). The 7th outcome of the study is the difference in numerical rating scale scores between study and control groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>opioid consumption</measure>
      <time_frame>Postoperative 24th hour.</time_frame>
      <description>Total opioid consumption of the patients will be recorded at the postoperative 24. hour.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">254</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Postoperative Pain, Acute</condition>
    <condition>Postoperative Pain, Chronic</condition>
    <condition>Neuropathic Pain</condition>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 30 ml of bupivacaine 0.25%.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No block procedure will be performed in this group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>RIB</intervention_name>
      <description>After endotracheal intubation, patients will be positioned in lateral decubitus position. A RIB will be performed at the level of T5-T6 by ultrasound guidance. A single shot block will be performed by injecting 30 ml of 0.25% bupivacaine to the interfacial plane between rhomboid major muscle and intercostal muscle.</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA I-II patients&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Ages between 18-65&#xD;
  &#xD;
            -  Patients who will receive breast cancer surgery under general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Alcohol or substance or chronic opioid consumption story&#xD;
  &#xD;
            -  Any pain killers intake in the last 24 hours prior to surgery&#xD;
  &#xD;
            -  Body mass index over 35 kg/m2&#xD;
  &#xD;
            -  Infection at the injection sites&#xD;
  &#xD;
            -  Known allergy to local anesthetics&#xD;
  &#xD;
            -  Known psychiatric diseases which prevents communication&#xD;
  &#xD;
            -  Operations longer than 3 hours&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>BAKİYE UĞUR</last_name>
      <role>Study Chair</role>
      <affiliation>Muğla Sıtkı Koçman University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>BAŞAK ALTIPARMAK, Ass Prof</last_name>
      <phone>+905326726533</phone>
      <email>basak_ugurlu@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Muğla Training and Research Hospital</name>
        <address>
          <city>Mugla</city>
          <state>Menteşe</state>
          <zip>48000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>BAŞAK ALTIPARMAK, ASSPROF</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Muğla Sıtkı Koçman University</investigator_affiliation>
      <investigator_full_name>Başak Altıparmak</investigator_full_name>
      <investigator_title>Associated Professor</investigator_title>
    </responsible_party>
    <keyword>analgesia</keyword>
    <keyword>acute pain</keyword>
    <keyword>chronic pain</keyword>
    <keyword>neuropathic pain</keyword>
    <keyword>rhomboid intercostal block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuralgia</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>IPD will not be shared with anyone</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019325
  org study id: 230022
  nct id: NCT06019325
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves
        between T3 and T9 dermatomes. RIB has been reported to be successful in attenuating acute
        pain following breast surgeries. However, it's effect on chronic pain has not been evaluated
        yet. The primary hypothesis of the study is that the incidence of chronic pain of the
        patients who will receive Rhomboid intercostal block (RIB) following breast cancer surgery
        will be lower than the patients who will receive no block intervention at the postoperative
        3rd month. The secondary hypothesis is that the incidence ofchronic pain of the patients who
        will receive Rhomboid intercostal block (RIB) following breast cancer surgery will be lower
        than the patients who will receive no block intervention at the postoperative 6th month. An
        other secondary hypothesis is that the total BPI-SF scores will be lower in the RIB group
        than control group at the postoperative 3rd and the 6th months.
  The study is designed as a prospective, double-blinded, randomize controlled study. The
        patients who will undergo mastectomy surgery with or without axillary dissection will be
        included in the study. Anesthesia will be inducted with intravenous (iv) thiopental 5 mg/kg,
        fentanyl 2 mcg/kg and rocuronium bromide 0.6 mg/kg. Following intubation, patients will be
        allocated into two groups according to a randomization table created by a professional
        statistician. In the study group, patients will receive a single shot Rhomboid Intercostal
        Block (RIB) with 30 milliliters of %0.25 bupivacaine and in the control group no block
        procedure will be performed. All patients will receive a standard analgesia protocol which
        will include an intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv
        tramadol 1 mg/kg 15 minutes prior to the end of the surgery. Postoperative pain intensity of
        the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges
        between 0 (no pain) and 10 (the worst pain that a person can stand). Pain scores of the
        patients will be recorded at the postoperative 15. and 30. min in the recovery room and if
        the NRS score is 4 or more, iv fentanyl 1 mcg/kg will be applied. At the surgical ward, pain
        scores will be evaluated at the postoperative 1st, 2nd, 6th, 12th and 24th hours and if the
        NRS score is 4 or more, iv tramadol 50 mg will be applied as rescue analgesia. Opioid
        consumptions of the patients will be recorded at the postoperative 24th hour. At the
        postoperative 3. and 6. months, a pain doctor will evaluate all patients by using Brief Pain
        Inventory Short Form (BPI-SF) and Douleur Neuropathique 4 (DN4) questionnaire.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, randomized, controlled study
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: The patients will be under general anesthesia and will not be aware if they receive a block procedure or not.
  The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups, but she will not involve in data collection.
  measure: 3rd month chronic pain
  time frame: At the postoperative 3. month
  description: The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 3rd month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Primary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 3rd month.
  measure: 6th month chronic pain
  time frame: At the postoperative 6. month
  description: The presence of chronic pain will be evaluated by using the 5. question of Brief Pain Inventory Short Form at the postoperative 6th month. The question ranges from 0 (which means no pain) to 10 points (which means worst pain). The score equal to or over 4 points indicates the presence of chronic pain. Secondary outcome of the study is the difference in the incidence of chronic pain between study and control groups at the postoperative 6th month.
  measure: 3rd month total Brief Pain Inventory Short Form Score
  time frame: At the postoperative 3. month
  description: Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 3rd month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 3rd month.
  measure: 6th month total Brief Pain Inventory Short Form Score
  time frame: At the postoperative 6. month
  description: Total score of Brief Pain Inventory Short Form of all patients will be recorded at the postoperative 6th month. The form ranges from 0 point (best score) to 120 (worst score) points. The 3rd outcome of the study is the difference in total Brief Pain Inventory Short Form scores of patients in the study and control groups at the postoperative 6th month.
  measure: 3rd month neuropathic pain
  time frame: At the postoperative 3. month
  description: The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 5th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups.
  measure: 6th month neuropathic pain
  time frame: At the postoperative 6. month
  description: The presence of neuropathic pain which will be evaluated by using Douleur Neuropathique 4 (DN4) which ranges from 0 point (no pain) to 10 points (worst pain). Score equal to or over 4 points indicates the presence of neuropathic pain. The 6th outcome of the study is the difference in the incidence of neuropathic pain between the study and control groups at the postoperative 6th month.
  measure: acute pain
  time frame: Postoperative 15. minute, 30. minute, 1.hour, 2nd hour, 6th hour, 12th hour, 24th hour
  description: Postoperative acute pain of the patients will be evaluated by using Numerical Rating Scale which ranges between 0 point (no pain) and 10 points (worst pain). The 7th outcome of the study is the difference in numerical rating scale scores between study and control groups.
  measure: opioid consumption
  time frame: Postoperative 24th hour.
  description: Total opioid consumption of the patients will be recorded at the postoperative 24. hour.
  arm group label: Study Group
  arm group type: Experimental
  description: After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 30 ml of bupivacaine 0.25%.
  arm group label: Control Group
  arm group type: No Intervention
  description: No block procedure will be performed in this group.
  intervention type: Procedure
  intervention name: RIB
  description: After endotracheal intubation, patients will be positioned in lateral decubitus position. A RIB will be performed at the level of T5-T6 by ultrasound guidance. A single shot block will be performed by injecting 30 ml of 0.25% bupivacaine to the interfacial plane between rhomboid major muscle and intercostal muscle.
  arm group label: Study Group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: BAKİYE UĞUR
  role: Study Chair
  affiliation: Muğla Sıtkı Koçman University
  last name: BAŞAK ALTIPARMAK, Ass Prof
  phone: +905326726533
  email: basak_ugurlu@yahoo.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Muğla Sıtkı Koçman University
  investigator full name: Başak Altıparmak
  investigator title: Associated Professor
  mesh term: Neuralgia
  mesh term: Pain, Postoperative
  mesh term: Chronic Pain
  mesh term: Acute Pain
  sharing ipd: No
  ipd description: IPD will not be shared with anyone