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/NCT05972122</url>
    </required_header>
    <id_info>
      <org_study_id>Medipol Hospital 34</org_study_id>
      <nct_id>NCT05972122</nct_id>
    </id_info>
    <brief_title>Serratus Posterior Superior Interfascial Plane Block for Thoracoscopic Surgery</brief_title>
    <official_title>The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: 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 VATS. Ultrasound&#xD;
        (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block&#xD;
        defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior&#xD;
        muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such&#xD;
        as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and&#xD;
        shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges&#xD;
        of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal&#xD;
        nerves. With the SPS block, these nerves are blocked and analgesia is provided.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical&#xD;
        procedure for lung surgery in recent years. The advantages of VATS compared to open&#xD;
        thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications.&#xD;
        Although it is a less painful surgical procedure compared to thoracotomy, severe acute&#xD;
        postoperative pain can be observed especially in the first hours after VATS. Thoracic&#xD;
        epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used&#xD;
        in analgesia after VATS. However, due to the difference in surgical technique and trauma&#xD;
        between open surgery and VATS, what should be the gold standard for analgesia after VATS is a&#xD;
        matter of debate. It is supported that less invasive analgesic techniques should be applied&#xD;
        for minimally invasive surgical procedures, especially due to the difficulty of applying TEA&#xD;
        and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line&#xD;
        regional technique for VATS surgery. However, it is difficult to apply due to its anatomical&#xD;
        proximity to important structures such as the pleura and central neuraxial system, and it may&#xD;
        cause complications such as pneumothorax and vascular injury. Analgesia management is very&#xD;
        important in these patients, as insufficient analgesia in the postoperative period may cause&#xD;
        pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.&#xD;
  &#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;
  &#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 stained, while the rhomboid&#xD;
        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. There is no randomized study in the literature&#xD;
        evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.&#xD;
  &#xD;
        In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative&#xD;
        analgesia management after VATS. Our primary aim is to compare postoperative opioid&#xD;
        consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related&#xD;
        side effects (allergic reaction, nausea, vomiting), and dermatome levels.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">November 30, 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>Opioid consumption (Fentanyl PCA)</measure>
      <time_frame>Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.</time_frame>
      <description>The primary aim is to compare postoperative opioid consumption from the PCA device.</description>
    </primary_outcome>
    <secondary_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 secondary aim is to compare NRS at the postoperative 24 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>
    </secondary_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>
    <other_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>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Lung Diseases</condition>
    <arm_group>
      <arm_group_label>Group S = SPSIPB group</arm_group_label>
      <arm_group_type>Placebo 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 intercostal 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. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. 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-III&#xD;
  &#xD;
            -  Scheduled for VATS under general anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of bleeding diathesis,&#xD;
  &#xD;
            -  receiving anticoagulant treatment,&#xD;
  &#xD;
            -  known local anesthetics and opioid allergy,&#xD;
  &#xD;
            -  infection of the skin at the site of the needle puncture,&#xD;
  &#xD;
            -  pregnancy or lactation,&#xD;
  &#xD;
            -  patients who do not accept the procedure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 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>VATS</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>Lung 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/NCT05972122
  org study id: Medipol Hospital 34
  nct id: NCT05972122
  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 VATS. 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.
  Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical
        procedure for lung surgery in recent years. The advantages of VATS compared to open
        thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications.
        Although it is a less painful surgical procedure compared to thoracotomy, severe acute
        postoperative pain can be observed especially in the first hours after VATS. Thoracic
        epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used
        in analgesia after VATS. However, due to the difference in surgical technique and trauma
        between open surgery and VATS, what should be the gold standard for analgesia after VATS is a
        matter of debate. It is supported that less invasive analgesic techniques should be applied
        for minimally invasive surgical procedures, especially due to the difficulty of applying TEA
        and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line
        regional technique for VATS surgery. However, it is difficult to apply due to its anatomical
        proximity to important structures such as the pleura and central neuraxial system, and it may
        cause complications such as pneumothorax and vascular injury. Analgesia management is very
        important in these patients, as insufficient analgesia in the postoperative period may cause
        pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.
  
        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.
  
        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 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. There is no randomized study in the literature
        evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.
  
        In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative
        analgesia management after VATS. Our primary aim is to compare postoperative opioid
        consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related
        side effects (allergic reaction, nausea, vomiting), and dermatome levels.
  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: Opioid consumption (Fentanyl PCA)
  time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
  description: The primary aim is to compare postoperative opioid consumption from the PCA device.
  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 secondary aim is to compare NRS at the postoperative 24 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: Placebo 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 intercostal 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. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. 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: All
  minimum age: 18 Years
  maximum age: 80 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: Lung Diseases
  sharing ipd: No
  ipd description: We will not plan to share IPD