<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/NCT03240562</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2017-06-123</org_study_id>
    <nct_id>NCT03240562</nct_id>
  </id_info>
  <brief_title>Ultrasound-guided Block for Thoracic Surgery Pain</brief_title>
  <official_title>Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be&#xD;
      effective in acute postoperative pain following thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Analgesic options for thoracotomy are various with each having their own merits and&#xD;
      demerits.Thoracic epidural is said to be the gold standard for management of thoracotomy&#xD;
      pain. However, it is invasive procedure and many side effects. Other options include&#xD;
      paravertebral block, interpleural block, intrathecal opioids. Especially, paravertebral block&#xD;
      is thought good alternative to epidural anethesia. Most of these invasive neuraxial&#xD;
      techniques demand normal coagulation parameters to be present.&#xD;
&#xD;
      The serratus anterior plane block(SAPB) was done under ultrasound guidance in the&#xD;
      mid-axillary line at the level of the fourth rib and the catheter was placed superficial to&#xD;
      the serratus plane. The patient expressed relief in pain within 10 minutes of being given the&#xD;
      bolus of local anaesthetic.Pain following thoracotomy is chiefly due to rib retraction, and&#xD;
      damage to the serratus/intercostal muscles and intercostal nerves. A SAPB addresses both&#xD;
      these aspects. SAPB has been mentioned in previous studies for management of rib fractures&#xD;
      and breast surgeries. The investigators try to evaluate whether the SAPB is easy to perform&#xD;
      and provides effective analgesia in patients undergoing thoracotomy with minimal side&#xD;
      effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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 (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>opioid consumption</measure>
    <time_frame>the first 24hour in postoperative phase</time_frame>
    <description>the dose of PCA and residual opioid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain scale</measure>
    <time_frame>intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour</time_frame>
    <description>numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>opioid consumption</measure>
    <time_frame>the first 6,12 hour in postoperative phase</time_frame>
    <description>the dose of PCA and residual opioid</description>
  </secondary_outcome>
  <other_outcome>
    <measure>questionnaire about patient's satisfaction for pain management</measure>
    <time_frame>postoperative 24 hour</time_frame>
    <description>score 1(bad)-5(good)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Thoracic Cancer</condition>
  <arm_group>
    <arm_group_label>IV-PCA group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>no block performing, only use intravenous patient controled analgesia(IV-PCA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAPB group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>serratus anterior plane block</intervention_name>
    <description>before surgery :ultrasound-guided serratus anterior plane block</description>
    <arm_group_label>SAPB group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>patient controlled analgesia</intervention_name>
    <description>two groups have same intravenous patient controlled analgesia</description>
    <arm_group_label>IV-PCA group</arm_group_label>
    <arm_group_label>SAPB group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •undergoing thoracic surgery (lobectomy or segmentectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • allergy to any drugs chronic pain disease with medication psychologic disorder&#xD;
        anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung medical center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Chu GM, Jarvis GC. Serratus Anterior Plane Block to Address Postthoracotomy and Chest Tube-Related Pain: A Report on 3 Cases. A A Case Rep. 2017 Jun 15;8(12):322-325. doi: 10.1213/XAA.0000000000000502.</citation>
    <PMID>28614112</PMID>
  </reference>
  <reference>
    <citation>Duceau B, Baubillier M, Bouroche G, Albi-Feldzer A, Jayr C. Pupillary Reflex for Evaluation of Thoracic Paravertebral Block: A Prospective Observational Feasibility Study. Anesth Analg. 2017 Oct;125(4):1342-1347. doi: 10.1213/ANE.0000000000002003.</citation>
    <PMID>28489642</PMID>
  </reference>
  <reference>
    <citation>Liu F, Zhang H, Zuo Y. Bilateral thoracic Paravertebral block for immediate postoperative pain relief in the PACU: a prospective, observational study. BMC Anesthesiol. 2017 Jul 5;17(1):89. doi: 10.1186/s12871-017-0378-3.</citation>
    <PMID>28679359</PMID>
  </reference>
  <reference>
    <citation>Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.</citation>
    <PMID>26431130</PMID>
  </reference>
  <reference>
    <citation>Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.</citation>
    <PMID>22219442</PMID>
  </reference>
  <reference>
    <citation>Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.</citation>
    <PMID>26000690</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>serratus anterior plane block</keyword>
  <keyword>ultrasound-guided</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>thoracic surgery</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03240562
org study id: SMC2017-06-123
nct id: NCT03240562
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be
      effective in acute postoperative pain following thoracic surgery.
Analgesic options for thoracotomy are various with each having their own merits and
      demerits.Thoracic epidural is said to be the gold standard for management of thoracotomy
      pain. However, it is invasive procedure and many side effects. Other options include
      paravertebral block, interpleural block, intrathecal opioids. Especially, paravertebral block
      is thought good alternative to epidural anethesia. Most of these invasive neuraxial
      techniques demand normal coagulation parameters to be present.

      The serratus anterior plane block(SAPB) was done under ultrasound guidance in the
      mid-axillary line at the level of the fourth rib and the catheter was placed superficial to
      the serratus plane. The patient expressed relief in pain within 10 minutes of being given the
      bolus of local anaesthetic.Pain following thoracotomy is chiefly due to rib retraction, and
      damage to the serratus/intercostal muscles and intercostal nerves. A SAPB addresses both
      these aspects. SAPB has been mentioned in previous studies for management of rib fractures
      and breast surgeries. The investigators try to evaluate whether the SAPB is easy to perform
      and provides effective analgesia in patients undergoing thoracotomy with minimal side
      effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: opioid consumption
time frame: the first 24hour in postoperative phase
description: the dose of PCA and residual opioid
measure: postoperative pain scale
time frame: intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
description: numeric rating scale
measure: opioid consumption
time frame: the first 6,12 hour in postoperative phase
description: the dose of PCA and residual opioid
measure: questionnaire about patient's satisfaction for pain management
time frame: postoperative 24 hour
description: score 1(bad)-5(good)
arm group label: IV-PCA group
arm group type: Sham Comparator
description: no block performing, only use intravenous patient controled analgesia(IV-PCA)
arm group label: SAPB group
arm group type: Experimental
description: serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)
intervention type: Procedure
intervention name: serratus anterior plane block
description: before surgery :ultrasound-guided serratus anterior plane block
arm group label: SAPB group
intervention type: Drug
intervention name: patient controlled analgesia
description: two groups have same intravenous patient controlled analgesia
arm group label: IV-PCA group
arm group label: SAPB group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
citation: Chu GM, Jarvis GC. Serratus Anterior Plane Block to Address Postthoracotomy and Chest Tube-Related Pain: A Report on 3 Cases. A A Case Rep. 2017 Jun 15;8(12):322-325. doi: 10.1213/XAA.0000000000000502.
PMID: 28614112
citation: Duceau B, Baubillier M, Bouroche G, Albi-Feldzer A, Jayr C. Pupillary Reflex for Evaluation of Thoracic Paravertebral Block: A Prospective Observational Feasibility Study. Anesth Analg. 2017 Oct;125(4):1342-1347. doi: 10.1213/ANE.0000000000002003.
PMID: 28489642
citation: Liu F, Zhang H, Zuo Y. Bilateral thoracic Paravertebral block for immediate postoperative pain relief in the PACU: a prospective, observational study. BMC Anesthesiol. 2017 Jul 5;17(1):89. doi: 10.1186/s12871-017-0378-3.
PMID: 28679359
citation: Terkawi AS, Tsang S, Sessler DI, Terkawi RS, Nunemaker MS, Durieux ME, Shilling A. Improving Analgesic Efficacy and Safety of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-Analysis. Pain Physician. 2015 Sep-Oct;18(5):E757-80.
PMID: 26431130
citation: Wildgaard K, Petersen RH, Hansen HJ, Moller-Sorensen H, Ringsted TK, Kehlet H. Multimodal analgesic treatment in video-assisted thoracic surgery lobectomy using an intraoperative intercostal catheter. Eur J Cardiothorac Surg. 2012 May;41(5):1072-7. doi: 10.1093/ejcts/ezr151. Epub 2011 Dec 21.
PMID: 22219442
citation: Madabushi R, Tewari S, Gautam SK, Agarwal A, Agarwal A. Serratus anterior plane block: a new analgesic technique for post-thoracotomy pain. Pain Physician. 2015 May-Jun;18(3):E421-4.
PMID: 26000690
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No