<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/NCT03839160</url>
  </required_header>
  <id_info>
    <org_study_id>truncal block SAPB</org_study_id>
    <nct_id>NCT03839160</nct_id>
  </id_info>
  <brief_title>The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study</brief_title>
  <official_title>The Efficacy of Serratus Anterior Plane Block in Analgesia for Thoracotomy: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</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>
      Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus&#xD;
      anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy&#xD;
      pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural&#xD;
      analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided&#xD;
      serratus anterior plane block (SAPB) is a relatively new truncal block method treating&#xD;
      thoracotomy pain, yet more evidence is needed to ascertain its efficacy.&#xD;
&#xD;
      This is a prospective study carried out in a tertiary hospital. Patients scheduled for&#xD;
      thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia&#xD;
      morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine&#xD;
      consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours&#xD;
      respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic&#xD;
      pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of&#xD;
      opioids-related side effects and length of hospital stay are documented. The primary&#xD;
      objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to&#xD;
      compare the opioids-related side effects (including nausea, vomiting and pruritus),&#xD;
      hemodynamic parameters and the length of hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analog scale</measure>
    <time_frame>Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>Adult Pain Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic profile - Heart rate</measure>
    <time_frame>At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic profile - blood pressure</measure>
    <time_frame>At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic profile - SpO2</measure>
    <time_frame>At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>SpO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioids-related side effects - nausea</measure>
    <time_frame>At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter-related profile</measure>
    <time_frame>at Day 1, Day2 and Day 3 post-operation</time_frame>
    <description>The position of the catheter tip and the level of blockade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation</time_frame>
    <description>Morphine consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Anesthesia</condition>
  <condition>Thoracotomy</condition>
  <arm_group>
    <arm_group_label>SAPB group. Group S</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group. Group C</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Serratus anterior plane block</intervention_name>
    <description>Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.</description>
    <arm_group_label>SAPB group. Group S</arm_group_label>
    <other_name>Serratus plane block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous patient-controlled-analgesia morphine</intervention_name>
    <description>Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.</description>
    <arm_group_label>Control group. Group C</arm_group_label>
    <arm_group_label>SAPB group. Group S</arm_group_label>
    <other_name>PCIA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  BMI 18-28kg/m2&#xD;
&#xD;
          -  Wedge incision and lobectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension or chronic conditions&#xD;
&#xD;
          -  History of opioid dependence&#xD;
&#xD;
          -  Allergy to bupivacaine hydrochloride&#xD;
&#xD;
          -  Severe bleeding during operation or post operation&#xD;
&#xD;
          -  Inability to communicate with investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jing Cang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 23, 2017</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03839160
org study id: truncal block SAPB
nct id: NCT03839160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus
      anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy
      pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.
Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural
      analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided
      serratus anterior plane block (SAPB) is a relatively new truncal block method treating
      thoracotomy pain, yet more evidence is needed to ascertain its efficacy.

      This is a prospective study carried out in a tertiary hospital. Patients scheduled for
      thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia
      morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine
      consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours
      respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic
      pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of
      opioids-related side effects and length of hospital stay are documented. The primary
      objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to
      compare the opioids-related side effects (including nausea, vomiting and pruritus),
      hemodynamic parameters and the length of hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: visual analog scale
time frame: Changes at 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: Adult Pain Visual Analog Scale
measure: Hemodynamic profile - Heart rate
time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: Heart rate
measure: Hemodynamic profile - blood pressure
time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: blood pressure
measure: Hemodynamic profile - SpO2
time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: SpO2
measure: Opioids-related side effects - nausea
time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: nausea
measure: Catheter-related profile
time frame: at Day 1, Day2 and Day 3 post-operation
description: The position of the catheter tip and the level of blockade
measure: Morphine consumption
time frame: At 2hr, 6hr, 12hr, 24hr, 48hr and 72hr post-operation
description: Morphine consumption
arm group label: SAPB group. Group S
arm group type: Active Comparator
description: In this group, serratus anterior plane block (SAPB) was performed before extubation with injection of 30 ml of 0.25% bupivacaine hydrochloride followed by 0.1ml/kg/hr of 0.12% bupivacaine hydrochloride. In addition to SAPB, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
arm group label: Control group. Group C
arm group type: Placebo Comparator
description: In this group, intravenous patient-controlled-analgesia morphine was used. Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
intervention type: Procedure
intervention name: Serratus anterior plane block
description: Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.
arm group label: SAPB group. Group S
other name: Serratus plane block
intervention type: Drug
intervention name: Intravenous patient-controlled-analgesia morphine
description: Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
arm group label: Control group. Group C
arm group label: SAPB group. Group S
other name: PCIA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jing Cang, MD
role: Study Chair
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Morphine