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/NCT05972083</url>
    </required_header>
    <id_info>
      <org_study_id>Medipol Hospital 33</org_study_id>
      <nct_id>NCT05972083</nct_id>
    </id_info>
    <brief_title>Serratus Posterior Superior Interfascial Plane Block for Breast Surgery</brief_title>
    <official_title>The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Pain Control in Female Patients Underwent Mastectomy and Axillary Lymph Node Dissection: A Randomized, Prospective, Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medipol University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medipol 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>
        Regional techniques can be used for postoperative pain control following breast surgery.&#xD;
        Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane&#xD;
        block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior&#xD;
        superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in&#xD;
        conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal&#xD;
        syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the&#xD;
        lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper&#xD;
        intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mastectomy and axillary lymph node dissection are among the most frequently performed&#xD;
        surgeries today, and pain control is an important problem affecting patient comfort in the&#xD;
        postoperative period in these patients. Postoperative pain is an acute pain associated with&#xD;
        the inflammatory process that occurs due to surgical trauma and gradually decreases with&#xD;
        tissue healing. Several analgesic drugs such as opioids are used to prevent this pain, but&#xD;
        these agents have many unwanted side effects. Successful postoperative analgesia occurs in&#xD;
        the patient due to pain; it is a known fact that it prevents many of the effects such as not&#xD;
        being able to breathe easily and delayed mobilization.&#xD;
  &#xD;
        Regional techniques can be used for postoperative pain control following breast surgery.&#xD;
        Ultrasound (US) guided serratus posterior superior block (SPSIPB) is a new interfacial plane&#xD;
        block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior&#xD;
        superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in&#xD;
        conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal&#xD;
        syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the&#xD;
        lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper&#xD;
        intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.&#xD;
  &#xD;
        In the cadaveric study of Tulgar et al., it was determined that the spread of serratus&#xD;
        posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in&#xD;
        the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal&#xD;
        levels, absent on the right. There was prominent staining on both sides of the deep trapezius&#xD;
        muscle. Both the surface and skin of the rhomboid major were clearly stained, while the&#xD;
        rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in&#xD;
        procedures involving the thoracic region such as chronic myofascial pain, breast surgery,&#xD;
        thoracic surgery, and shoulder surgery.&#xD;
  &#xD;
        In this study, our aim is to investigate the efficacy of US-guided SPSIPB for postoperative&#xD;
        analgesia management after mastectomy and axillary lymph node dissection surgery. Our primary&#xD;
        aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate the&#xD;
        need for rescue analgesics, block-related complications, dermatome level, and side effects&#xD;
        (allergic reaction, nausea, vomiting) associated with opioid use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">November 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 20, 2023</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>There are two models for this study. The first group is the SPSIPB group. The second one is the control group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain scores (Numerical rating scale-NRS)</measure>
      <time_frame>Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours</time_frame>
      <description>The primary aim is to compare NRS at the postoperative 1st h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Need for rescue analgesia (meperidine)</measure>
      <time_frame>Postoperative 24 hours period</time_frame>
      <description>The secondary aim is to compare rescue analgesia used in the postoperative 24 h.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Postoperative 24 hours period</time_frame>
      <description>The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dermatomal analyses</measure>
      <time_frame>Postoperative 1st hour</time_frame>
      <description>The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Breast Diseases</condition>
    <arm_group>
      <arm_group_label>Group S = SPSIPB group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C = Control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The wound infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Analgesia management; group S and C</intervention_name>
      <description>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.</description>
      <arm_group_label>Group C = Control group</arm_group_label>
      <arm_group_label>Group S = SPSIPB group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
  &#xD;
            -  Scheduled for mastectomy and axillary dissection surgery under general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  receiving anticoagulant treatment,&#xD;
  &#xD;
            -  known study drugs allergy,&#xD;
  &#xD;
            -  opioid addiction&#xD;
  &#xD;
            -  infection of the skin at the site of the block,&#xD;
  &#xD;
            -  pregnancy or lactation,&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female patients who will undergo breast surgery will be included</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bahadır Çiftçi, Assoc prof, MD</last_name>
      <phone>05343736865</phone>
      <email>bciftci@medipol.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Selçuk Alver, Assist prof, MD</last_name>
      <email>selcukalver@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istanbul Medipol University Hospital</name>
        <address>
          <city>Istanbul</city>
          <state>Bagcilar</state>
          <zip>34070</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bahadir Ciftci, MD</last_name>
        <phone>+905325034428</phone>
        <email>bciftci@medipol.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.</citation>
      <PMID>36883093</PMID>
    </reference>
    <reference>
      <citation>Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Jun 1. doi: 10.23736/S0375-9393.23.17432-3. Online ahead of print. No abstract available.</citation>
      <PMID>37272274</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medipol University</investigator_affiliation>
      <investigator_full_name>Bahadir Ciftci</investigator_full_name>
      <investigator_title>Primary researcher</investigator_title>
    </responsible_party>
    <keyword>Mastectomy and axillary dissection surgery</keyword>
    <keyword>Postoperative pain management</keyword>
    <keyword>Serratus Posterior Superior Interfascial Plane Block</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>We will not plan to share IPD</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/NCT05972083
  org study id: Medipol Hospital 33
  nct id: NCT05972083
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Regional techniques can be used for postoperative pain control following breast surgery.
        Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane
        block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior
        superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in
        conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal
        syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the
        lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper
        intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
  Mastectomy and axillary lymph node dissection are among the most frequently performed
        surgeries today, and pain control is an important problem affecting patient comfort in the
        postoperative period in these patients. Postoperative pain is an acute pain associated with
        the inflammatory process that occurs due to surgical trauma and gradually decreases with
        tissue healing. Several analgesic drugs such as opioids are used to prevent this pain, but
        these agents have many unwanted side effects. Successful postoperative analgesia occurs in
        the patient due to pain; it is a known fact that it prevents many of the effects such as not
        being able to breathe easily and delayed mobilization.
  
        Regional techniques can be used for postoperative pain control following breast surgery.
        Ultrasound (US) guided serratus posterior superior block (SPSIPB) is a new interfacial plane
        block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior
        superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in
        conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal
        syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the
        lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper
        intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
  
        In the cadaveric study of Tulgar et al., it was determined that the spread of serratus
        posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in
        the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal
        levels, absent on the right. There was prominent staining on both sides of the deep trapezius
        muscle. Both the surface and skin of the rhomboid major were clearly stained, while the
        rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in
        procedures involving the thoracic region such as chronic myofascial pain, breast surgery,
        thoracic surgery, and shoulder surgery.
  
        In this study, our aim is to investigate the efficacy of US-guided SPSIPB for postoperative
        analgesia management after mastectomy and axillary lymph node dissection surgery. Our primary
        aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate the
        need for rescue analgesics, block-related complications, dermatome level, and side effects
        (allergic reaction, nausea, vomiting) associated with opioid use.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: There are two models for this study. The first group is the SPSIPB group. The second one is the control group.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.
  measure: Pain scores (Numerical rating scale-NRS)
  time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours
  description: The primary aim is to compare NRS at the postoperative 1st h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
  measure: Need for rescue analgesia (meperidine)
  time frame: Postoperative 24 hours period
  description: The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
  measure: Adverse events
  time frame: Postoperative 24 hours period
  description: The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.
  measure: Dermatomal analyses
  time frame: Postoperative 1st hour
  description: The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.
  arm group label: Group S = SPSIPB group
  arm group type: Active Comparator
  description: A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
  arm group label: Group C = Control group
  arm group type: Other
  description: The wound infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.
  intervention type: Drug
  intervention name: Analgesia management; group S and C
  description: Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
  arm group label: Group C = Control group
  arm group label: Group S = SPSIPB group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female patients who will undergo breast surgery will be included
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Bahadır Çiftçi, Assoc prof, MD
  phone: 05343736865
  email: bciftci@medipol.edu.tr
  last name: Selçuk Alver, Assist prof, MD
  email: selcukalver@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
  PMID: 36883093
  citation: Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Jun 1. doi: 10.23736/S0375-9393.23.17432-3. Online ahead of print. No abstract available.
  PMID: 37272274
  responsible party type: Principal Investigator
  investigator affiliation: Medipol University
  investigator full name: Bahadir Ciftci
  investigator title: Primary researcher
  mesh term: Breast Diseases
  sharing ipd: No
  ipd description: We will not plan to share IPD