<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/NCT03277391</url>
  </required_header>
  <id_info>
    <org_study_id>P2017/170</org_study_id>
    <nct_id>NCT03277391</nct_id>
  </id_info>
  <brief_title>Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery</brief_title>
  <acronym>Serrathos</acronym>
  <official_title>Serratus Anterior Plane Block: Post-operative Analgesia Technique in Video-assisted Thoracic Surgery. Efficacy Pilot Study and Population Pharmacokinetic Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Libre de Bruxelles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Libre de Bruxelles</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>
      The objective of the study is to compare the efficacy of the Serratus Anterior Plane block&#xD;
      (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours,&#xD;
      to a standard intravenous analgesia for small videoassisted thoracic surgery interventions.&#xD;
      The objective is also to evaluate the resorption rate of local anesthetic at this level, and&#xD;
      make a population pharmacokinetic analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, 20 patients will be randomly assigned to one of two groups: ten patients will&#xD;
      have a Serratus anterior plane block (SPB), with a first ropivacaine 0,375% bolus (0,4ml/kg),&#xD;
      followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter&#xD;
      located under the serratus anterior muscle, for a duration of 24 hours. The other group will&#xD;
      have a standard intravenous analgesia with a PCA morphine-dehydrobenzperidol pump. Anesthesia&#xD;
      protocol will be standardized. Except the infusion of ropivacaine for the SPB, per operative&#xD;
      anesthesia and post operative analgesia will be the same for every usual patients.&#xD;
&#xD;
      The investigators will evaluate post operative pain based on the visual analog scale, 24&#xD;
      hours morphine consumption, sensitivity of concerned territory. The investigators will also&#xD;
      evaluate post operative chronic pain by assessing pain two months post operatively,&#xD;
      completing two questionnaires of neuropathic pain: DN4 and QDSA short form.&#xD;
&#xD;
      Finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over&#xD;
      24 hours after realizing the SPB, in order to make a population pharmacokinetic analysis, and&#xD;
      evaluate the degree of ropivacaine resorption at this level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 14, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>Single (Participant)</masking>
    <masking_description>Random attribution by computer</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption (mg)</measure>
    <time_frame>24 hours</time_frame>
    <description>Consumption of intravenous morphine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>24 hours</time_frame>
    <description>Visual Analog Score: assess pain on surgical site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative nausea</measure>
    <time_frame>24 hours</time_frame>
    <description>Presence or absence of nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative vomiting</measure>
    <time_frame>24hrs</time_frame>
    <description>Presence or absence of vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of SPB zone</measure>
    <time_frame>24 hours</time_frame>
    <description>Cold (ether) applied on the skin of the operated hemithorax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative chronic pain</measure>
    <time_frame>2 months</time_frame>
    <description>Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative chronic pain</measure>
    <time_frame>2 months</time_frame>
    <description>Two months after surgery: DN4 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Regional Anesthesia</condition>
  <condition>Thoracic Surgery</condition>
  <condition>Post-operative Pain</condition>
  <condition>Post-operative Chronic Pain</condition>
  <condition>Pharmacokinetic Analysis</condition>
  <condition>Serratus Anterior Plane Block</condition>
  <arm_group>
    <arm_group_label>Serratus anterior plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Deep serratus anterior plane block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient-controlled analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Serratus anterior plane block</intervention_name>
    <description>SPB realized under ultrasound guidance. Infiltration of local anesthetic (bolus then infusion through a multi-holed catheter) is realized under the serratus anterior muscle at a level situated around the 5th to 6th intercostal space on the anterior axillary lign, in order to anesthetize the cutaneous lateral branches of the intercostal nerves, with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter, for a duration of 24 hours.</description>
    <arm_group_label>Serratus anterior plane block</arm_group_label>
    <other_name>Deep serratus anterior plane block</other_name>
    <other_name>SPB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>patient-controlled analgesia</intervention_name>
    <description>Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.</description>
    <arm_group_label>Serratus anterior plane block</arm_group_label>
    <arm_group_label>patient-controlled analgesia</arm_group_label>
    <other_name>PCA morphine dehydrobenzperidol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        American Society of Anesthesiologists physic status 1, 2 and 3 who require surgical&#xD;
        video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy&#xD;
&#xD;
          1. Lung pathologies:&#xD;
&#xD;
               -  biopsies&#xD;
&#xD;
               -  symphysis, pleurectomy&#xD;
&#xD;
               -  emphysema bullae resection&#xD;
&#xD;
          2. pleural pathologies:&#xD;
&#xD;
               -  biopsies&#xD;
&#xD;
               -  collections, intra pleural effusion&#xD;
&#xD;
          3. mediastinal pathologies:&#xD;
&#xD;
               -  adenopathy staging&#xD;
&#xD;
               -  cysts&#xD;
&#xD;
               -  sympathectomy T2-T5&#xD;
&#xD;
               -  vagotomy&#xD;
&#xD;
               -  splanchnicectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. refusal&#xD;
&#xD;
          2. allergy to local anesthetic - contra-indication to the use of ropivacaine&#xD;
&#xD;
          3. pregnancy&#xD;
&#xD;
          4. liver failure&#xD;
&#xD;
          5. severe kidney disease (GFR &lt; 15ml/min)&#xD;
&#xD;
          6. chronic intake of opioids&#xD;
&#xD;
          7. neurological or psychiatric disorders interfering with pain assessment&#xD;
&#xD;
          8. severe and morbid obesity (BMI &gt; 35)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luc Van Obbergh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology chief</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul Gruson</last_name>
    <phone>0032 2 555 5850</phone>
    <email>paulgruson.dr@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hopital Erasme</name>
      <address>
        <city>Anderlecht</city>
        <state>Bruxelles</state>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>+3225553111</phone>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.</citation>
    <PMID>15232812</PMID>
  </reference>
  <reference>
    <citation>Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.</citation>
    <PMID>23923989</PMID>
  </reference>
  <reference>
    <citation>Font MC, Navarro-Martinez J, Nadal SB, Munoz CG, Galiana-Ivars M, Montero PC. Continuous Analgesia Using a Multi-Holed Catheter in Serratus Plane for Thoracic Surgery. Pain Physician. 2016 May;19(4):E684-5. No abstract available.</citation>
    <PMID>27228541</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>
  <reference>
    <citation>Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available.</citation>
    <PMID>26449303</PMID>
  </reference>
  <reference>
    <citation>Cruccu G, Sommer C, Anand P, Attal N, Baron R, Garcia-Larrea L, Haanpaa M, Jensen TS, Serra J, Treede RD. EFNS guidelines on neuropathic pain assessment: revised 2009. Eur J Neurol. 2010 Aug;17(8):1010-8. doi: 10.1111/j.1468-1331.2010.02969.x. Epub 2010 Mar 8.</citation>
    <PMID>20298428</PMID>
  </reference>
  <reference>
    <citation>Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, Kim M. Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015 Apr;16(4):357-66. doi: 10.1016/j.jpain.2015.01.012. Epub 2015 Jan 29.</citation>
    <PMID>25640290</PMID>
  </reference>
  <reference>
    <citation>Kopacz DJ, Emanuelsson BM, Thompson GE, Carpenter RL, Stephenson CA. Pharmacokinetics of ropivacaine and bupivacaine for bilateral intercostal blockade in healthy male volunteers. Anesthesiology. 1994 Nov;81(5):1139-48. doi: 10.1097/00000542-199411000-00007.</citation>
    <PMID>7978472</PMID>
  </reference>
  <reference>
    <citation>Scott DB, Lee A, Fagan D, Bowler GM, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989 Nov;69(5):563-9.</citation>
    <PMID>2679230</PMID>
  </reference>
  <results_reference>
    <citation>Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.</citation>
    <PMID>18713924</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Libre de Bruxelles</investigator_affiliation>
    <investigator_full_name>Paul Gruson</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Droperidol</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_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/NCT03277391
org study id: P2017/170
nct id: NCT03277391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to compare the efficacy of the Serratus Anterior Plane block
      (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours,
      to a standard intravenous analgesia for small videoassisted thoracic surgery interventions.
      The objective is also to evaluate the resorption rate of local anesthetic at this level, and
      make a population pharmacokinetic analysis.
In this study, 20 patients will be randomly assigned to one of two groups: ten patients will
      have a Serratus anterior plane block (SPB), with a first ropivacaine 0,375% bolus (0,4ml/kg),
      followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter
      located under the serratus anterior muscle, for a duration of 24 hours. The other group will
      have a standard intravenous analgesia with a PCA morphine-dehydrobenzperidol pump. Anesthesia
      protocol will be standardized. Except the infusion of ropivacaine for the SPB, per operative
      anesthesia and post operative analgesia will be the same for every usual patients.

      The investigators will evaluate post operative pain based on the visual analog scale, 24
      hours morphine consumption, sensitivity of concerned territory. The investigators will also
      evaluate post operative chronic pain by assessing pain two months post operatively,
      completing two questionnaires of neuropathic pain: DN4 and QDSA short form.

      Finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over
      24 hours after realizing the SPB, in order to make a population pharmacokinetic analysis, and
      evaluate the degree of ropivacaine resorption at this level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Random attribution by computer
measure: Morphine consumption (mg)
time frame: 24 hours
description: Consumption of intravenous morphine
measure: Pain score
time frame: 24 hours
description: Visual Analog Score: assess pain on surgical site
measure: Post operative nausea
time frame: 24 hours
description: Presence or absence of nausea
measure: Post operative vomiting
time frame: 24hrs
description: Presence or absence of vomiting
measure: Sensitivity of SPB zone
time frame: 24 hours
description: Cold (ether) applied on the skin of the operated hemithorax
measure: Post operative chronic pain
time frame: 2 months
description: Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine)
measure: Post operative chronic pain
time frame: 2 months
description: Two months after surgery: DN4 questionnaire
arm group label: Serratus anterior plane block
arm group type: Active Comparator
description: Deep serratus anterior plane block
arm group label: patient-controlled analgesia
arm group type: Active Comparator
description: patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).
intervention type: Procedure
intervention name: Serratus anterior plane block
description: SPB realized under ultrasound guidance. Infiltration of local anesthetic (bolus then infusion through a multi-holed catheter) is realized under the serratus anterior muscle at a level situated around the 5th to 6th intercostal space on the anterior axillary lign, in order to anesthetize the cutaneous lateral branches of the intercostal nerves, with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter, for a duration of 24 hours.
arm group label: Serratus anterior plane block
other name: Deep serratus anterior plane block
other name: SPB
intervention type: Device
intervention name: patient-controlled analgesia
description: Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.
arm group label: Serratus anterior plane block
arm group label: patient-controlled analgesia
other name: PCA morphine dehydrobenzperidol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Luc Van Obbergh
role: Principal Investigator
affiliation: Anesthesiology chief
last name: Paul Gruson
phone: 0032 2 555 5850
email: paulgruson.dr@gmail.com
facility: 
status: Recruiting
contact: 
country: Belgium
citation: Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.
PMID: 15232812
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
PMID: 23923989
citation: Font MC, Navarro-Martinez J, Nadal SB, Munoz CG, Galiana-Ivars M, Montero PC. Continuous Analgesia Using a Multi-Holed Catheter in Serratus Plane for Thoracic Surgery. Pain Physician. 2016 May;19(4):E684-5. No abstract available.
PMID: 27228541
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
citation: Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available.
PMID: 26449303
citation: Cruccu G, Sommer C, Anand P, Attal N, Baron R, Garcia-Larrea L, Haanpaa M, Jensen TS, Serra J, Treede RD. EFNS guidelines on neuropathic pain assessment: revised 2009. Eur J Neurol. 2010 Aug;17(8):1010-8. doi: 10.1111/j.1468-1331.2010.02969.x. Epub 2010 Mar 8.
PMID: 20298428
citation: Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, Kim M. Validation of the Short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015 Apr;16(4):357-66. doi: 10.1016/j.jpain.2015.01.012. Epub 2015 Jan 29.
PMID: 25640290
citation: Kopacz DJ, Emanuelsson BM, Thompson GE, Carpenter RL, Stephenson CA. Pharmacokinetics of ropivacaine and bupivacaine for bilateral intercostal blockade in healthy male volunteers. Anesthesiology. 1994 Nov;81(5):1139-48. doi: 10.1097/00000542-199411000-00007.
PMID: 7978472
citation: Scott DB, Lee A, Fagan D, Bowler GM, Bloomfield P, Lundh R. Acute toxicity of ropivacaine compared with that of bupivacaine. Anesth Analg. 1989 Nov;69(5):563-9.
PMID: 2679230
citation: Joshi GP, Bonnet F, Shah R, Wilkinson RC, Camu F, Fischer B, Neugebauer EA, Rawal N, Schug SA, Simanski C, Kehlet H. A systematic review of randomized trials evaluating regional techniques for postthoracotomy analgesia. Anesth Analg. 2008 Sep;107(3):1026-40. doi: 10.1213/01.ane.0000333274.63501.ff.
PMID: 18713924
responsible party type: Principal Investigator
investigator affiliation: Université Libre de Bruxelles
investigator full name: Paul Gruson
investigator title: Principal investigator
mesh term: Chronic Pain
mesh term: Pain, Postoperative
mesh term: Droperidol
mesh term: Morphine
sharing ipd: No