<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/NCT03768193</url>
  </required_header>
  <id_info>
    <org_study_id>1/378/1918</org_study_id>
    <nct_id>NCT03768193</nct_id>
  </id_info>
  <brief_title>Deep Serratus Anterior Plane Block vs Surgically-placed Paravertebral Block for VATS Surgery</brief_title>
  <acronym>SAPB</acronym>
  <official_title>Comparison of Ultrasound-guided Continuous Serratus Anterior Plane Blockade With Continuous Thoracic Paravertebral Blockade for Perioperative Analgesia Following Video-assisted Thoracoscopic Surgery (VATS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mater Misericordiae University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mater Misericordiae University 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly&#xD;
      controlled acute pain, which may result in delayed functional recovery, and may progress to&#xD;
      chronic pain. Multimodal opioid-sparing analgesia regimens are a key component of the&#xD;
      thoracic surgery enhanced recovery pathway, the aim of which is to improve outcomes in&#xD;
      patients undergoing both minimally invasive and open thoracic surgical procedures. Novel&#xD;
      interfascial plane blocks are emerging as feasible alternatives to central neuraxial&#xD;
      analgesia techniques in a variety of clinical settings.&#xD;
&#xD;
      The aim of this study is to show non-inferiority of serratus anterior blockade compared with&#xD;
      surgically placed paravertebral blocks in the management of perioperative acute pain in&#xD;
      patients undergoing VATS procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-thoracotomy pain syndrome is an unwanted complication of thoracic surgery. Poorly&#xD;
      controlled pain may precipitate increased morbidity in the immediate and early postoperative&#xD;
      periods due to its adverse effects on respiratory mechanics and mobilisation, which may&#xD;
      result in further morbidity such as postoperative pulmonary complications and thrombosis.&#xD;
      Poor perioperative management of this pain may also result in the development of chronic&#xD;
      pain. Enhanced recovery, particularly functional recovery has become an important goal in the&#xD;
      perioperative management of our patients. A key principle of this pathway is multimodal&#xD;
      opioid-sparing analgesia to facilitate improved recovery and patient outcomes. Regional&#xD;
      anaesthesia forms the cornerstone of this multimodal analgesia regimen.&#xD;
&#xD;
      Traditionally, thoracic epidural and thoracic paravertebral blockade have been the main forms&#xD;
      of regional anaesthesia utilised in thoracic surgical patients undergoing lung resection.&#xD;
      With the increasing use of minimally invasive thoracic surgery and with a cohort of patients&#xD;
      who may not always be suitable for central neuraxial blockade, alternatives are needed. More&#xD;
      recently, there has been an emerging use of interfascial plane blocks in this patient group.&#xD;
      The interest in these techniques is derived from case reports, case series, cadaveric&#xD;
      studies, and small clinical trials, which have demonstrated clinical efficacy in a variety of&#xD;
      elective and emergency thoracic surgical procedures and also in chronic thoracic pain&#xD;
      syndromes.&#xD;
&#xD;
      The deep serratus anterior plane (deep SAP) block is a relatively new interfascial plane&#xD;
      regional anaesthesia technique, which has been postulated to provide analgesia of the entire&#xD;
      hemithorax. The mechanism of its analgesic effects are believed to occur via blockade of the&#xD;
      lateral cutaneous branches of the thoracic intercostal nerves (T2-T12), which produces&#xD;
      analgesia of the anterolateral chest wall. A recent anatomical study by Mayes et al.&#xD;
      demonstrated consistent blockade of the lateral cutaneous branches of the intercostal nerves.&#xD;
      Clinical studies, although small, have shown dermatomal spread in the T2 - T9 distribution of&#xD;
      the anterolateral chest wall. Therefore, this block presents a potential alternative to&#xD;
      central neuraxial blockade.&#xD;
&#xD;
      However, whether SAP blockade can produce non-inferior analgesia compared with either&#xD;
      thoracic epidural or thoracic paravertebral, both in terms of somatic +/- autonomic blockade,&#xD;
      and the reliability of dermatomal spread, has been questioned by some.&#xD;
&#xD;
      The aim of this randomised controlled trial is to demonstrate non-inferiority of&#xD;
      ultrasound-guided continuous deep serratus anterior plane blockade compared with&#xD;
      surgically-placed continuous paravertebral blockade, for perioperative analgesia, in the&#xD;
      patients undergoing minimally-invasive videoscopic thoracic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Expressed as oral morphine equivalent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative numerical pain scores</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid side - effects - 1</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Sedation scale. 0 = wide awake, 1 = drowsy but responds to normal verbal communication, 2 = asleep, but awakes with verbal communication. 3 = asleep, awakens with mild physical stimulation. 4 = asleep, unresponsive to physical stimulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid side - effects - 2</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid side - effects - 3</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure</measure>
    <time_frame>Over the first 48 hours postoperatively.</time_frame>
    <description>Calculated from systolic and diastolic blood pressure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dermatomal sensory block distribution</measure>
    <time_frame>Within the first 24 hours postoperatively</time_frame>
    <description>Dermatomal sensory block distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional assessment</measure>
    <time_frame>Within the first 48 hours postoperatively</time_frame>
    <description>Walking distance in meters assessed by physiotherapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Over the first 48 hours postoperatively</time_frame>
    <description>Subjective patient satisfaction scale. Subjective scale assessing Level of overall patient satisfaction with perioperative analgesia. Patient rates their experience as either 1 = insufficient, 2 = sufficient, 3 = very good, 4 =excellent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of inpatient hospital admission</measure>
    <time_frame>From date of admission for surgery to date of discharge by the thoracic team; through to study completion.</time_frame>
    <description>Measured in days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Thoracic Diseases</condition>
  <condition>Thoracic Surgery</condition>
  <condition>Rib Fractures</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Pain, Procedural</condition>
  <condition>Anaesthesia, Regional</condition>
  <arm_group>
    <arm_group_label>Deep serratus anterior plane block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided deposition of 40mls of 2mg/ kg levobupivacaine into the deep serratus anterior plane space, in the mid axillary line, at the level of the 4th/5th rib. Insertion of a continuous local anaesthetic infusion catheter(Portex™) and continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgically-placed paravertebral block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical placement of paravertebral local anaesthetic infusion catheters (Portex™) prior to closure. Bolus of levobupivacaine as per protocol. Continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep serratus anterior plane block</intervention_name>
    <description>Deposition of local anaesthetic in the space between the serratus anterior muscle and the external intercostal muscle, at the level of the 4th-5th rib, in the midaxillary line. Procedure performed under ultrasound guidance. Catheter - based infusion of local anaesthetic into this space for 48 hours.</description>
    <arm_group_label>Deep serratus anterior plane block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgically-placed paravertebral block</intervention_name>
    <description>Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.</description>
    <arm_group_label>Surgically-placed paravertebral block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • All adults greater than or equal to 18 years of age presenting for minimally-invasive&#xD;
        thoracic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Local infection at site of insertion.&#xD;
&#xD;
          -  Allergy to amide local anaesthetics, opioids, paracetamol, NSAIDs, ketamine, NMBs,&#xD;
             volatile anaesthetics.&#xD;
&#xD;
          -  Concurrent use of antiarrhythmics with local anaesthetic activity.&#xD;
&#xD;
          -  Concurrent use of MAOIs or within 2 weeks of MAOI use.&#xD;
&#xD;
          -  Severe renal, liver or cardiac dysfunction.&#xD;
&#xD;
          -  Coagulopathy/ anticoagulants that preclude use of PVB/ SAP techniques.&#xD;
&#xD;
          -  Inability to comprehend pain scoring system.&#xD;
&#xD;
          -  Elderly or frail patients that require a reduction in levobupivacaine dose&#xD;
             commensurate with their physical status, resulting in the protocol not being followed.&#xD;
&#xD;
          -  Pregnancy, breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Anaesthetist, Mater Misericordiae University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mater Misericordiae University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Conor Hearty</investigator_full_name>
    <investigator_title>Consultant Anaesthetist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Pain, Procedural</mesh_term>
    <mesh_term>Rib Fractures</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>February 3, 2021</submitted>
    <returned>February 23, 2021</returned>
    <submitted>April 13, 2021</submitted>
    <returned>May 7, 2021</returned>
  </pending_results>
  <!-- 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/NCT03768193
org study id: 1/378/1918
nct id: NCT03768193
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Thoracic surgery, and surgery involving the chest wall in general, is associated with poorly
      controlled acute pain, which may result in delayed functional recovery, and may progress to
      chronic pain. Multimodal opioid-sparing analgesia regimens are a key component of the
      thoracic surgery enhanced recovery pathway, the aim of which is to improve outcomes in
      patients undergoing both minimally invasive and open thoracic surgical procedures. Novel
      interfascial plane blocks are emerging as feasible alternatives to central neuraxial
      analgesia techniques in a variety of clinical settings.

      The aim of this study is to show non-inferiority of serratus anterior blockade compared with
      surgically placed paravertebral blocks in the management of perioperative acute pain in
      patients undergoing VATS procedures.
Post-thoracotomy pain syndrome is an unwanted complication of thoracic surgery. Poorly
      controlled pain may precipitate increased morbidity in the immediate and early postoperative
      periods due to its adverse effects on respiratory mechanics and mobilisation, which may
      result in further morbidity such as postoperative pulmonary complications and thrombosis.
      Poor perioperative management of this pain may also result in the development of chronic
      pain. Enhanced recovery, particularly functional recovery has become an important goal in the
      perioperative management of our patients. A key principle of this pathway is multimodal
      opioid-sparing analgesia to facilitate improved recovery and patient outcomes. Regional
      anaesthesia forms the cornerstone of this multimodal analgesia regimen.

      Traditionally, thoracic epidural and thoracic paravertebral blockade have been the main forms
      of regional anaesthesia utilised in thoracic surgical patients undergoing lung resection.
      With the increasing use of minimally invasive thoracic surgery and with a cohort of patients
      who may not always be suitable for central neuraxial blockade, alternatives are needed. More
      recently, there has been an emerging use of interfascial plane blocks in this patient group.
      The interest in these techniques is derived from case reports, case series, cadaveric
      studies, and small clinical trials, which have demonstrated clinical efficacy in a variety of
      elective and emergency thoracic surgical procedures and also in chronic thoracic pain
      syndromes.

      The deep serratus anterior plane (deep SAP) block is a relatively new interfascial plane
      regional anaesthesia technique, which has been postulated to provide analgesia of the entire
      hemithorax. The mechanism of its analgesic effects are believed to occur via blockade of the
      lateral cutaneous branches of the thoracic intercostal nerves (T2-T12), which produces
      analgesia of the anterolateral chest wall. A recent anatomical study by Mayes et al.
      demonstrated consistent blockade of the lateral cutaneous branches of the intercostal nerves.
      Clinical studies, although small, have shown dermatomal spread in the T2 - T9 distribution of
      the anterolateral chest wall. Therefore, this block presents a potential alternative to
      central neuraxial blockade.

      However, whether SAP blockade can produce non-inferior analgesia compared with either
      thoracic epidural or thoracic paravertebral, both in terms of somatic +/- autonomic blockade,
      and the reliability of dermatomal spread, has been questioned by some.

      The aim of this randomised controlled trial is to demonstrate non-inferiority of
      ultrasound-guided continuous deep serratus anterior plane blockade compared with
      surgically-placed continuous paravertebral blockade, for perioperative analgesia, in the
      patients undergoing minimally-invasive videoscopic thoracic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Opioid consumption
time frame: Over the first 48 hours postoperatively
description: Expressed as oral morphine equivalent
measure: Postoperative numerical pain scores
time frame: Over the first 48 hours postoperatively
description: Numerical rating scale. 0 - 10. 0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain.
measure: Opioid side - effects - 1
time frame: Over the first 48 hours postoperatively
description: Sedation scale. 0 = wide awake, 1 = drowsy but responds to normal verbal communication, 2 = asleep, but awakes with verbal communication. 3 = asleep, awakens with mild physical stimulation. 4 = asleep, unresponsive to physical stimulation.
measure: Opioid side - effects - 2
time frame: Over the first 48 hours postoperatively
description: Nausea/ vomiting scale. Questionnaire. 0= none, 1=mild, 2=moderate, 3=severe
measure: Opioid side - effects - 3
time frame: Over the first 48 hours postoperatively
description: Itch/ Pruritis scale 0= none, 1=mild, 2=moderate, 3=severe
measure: Mean arterial blood pressure
time frame: Over the first 48 hours postoperatively.
description: Calculated from systolic and diastolic blood pressure.
measure: Presence of dermatomal sensory block distribution
time frame: Within the first 24 hours postoperatively
description: Dermatomal sensory block distribution
measure: Functional assessment
time frame: Within the first 48 hours postoperatively
description: Walking distance in meters assessed by physiotherapist
measure: Patient satisfaction
time frame: Over the first 48 hours postoperatively
description: Subjective patient satisfaction scale. Subjective scale assessing Level of overall patient satisfaction with perioperative analgesia. Patient rates their experience as either 1 = insufficient, 2 = sufficient, 3 = very good, 4 =excellent.
measure: Duration of inpatient hospital admission
time frame: From date of admission for surgery to date of discharge by the thoracic team; through to study completion.
description: Measured in days.
arm group label: Deep serratus anterior plane block
arm group type: Experimental
description: Ultrasound-guided deposition of 40mls of 2mg/ kg levobupivacaine into the deep serratus anterior plane space, in the mid axillary line, at the level of the 4th/5th rib. Insertion of a continuous local anaesthetic infusion catheter(Portex™) and continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours.
arm group label: Surgically-placed paravertebral block
arm group type: Active Comparator
description: Surgical placement of paravertebral local anaesthetic infusion catheters (Portex™) prior to closure. Bolus of levobupivacaine as per protocol. Continuation of an infusion of 0.125% levobupivacaine at a rate of 8-12mls/ hour for 48 hours.
intervention type: Procedure
intervention name: Deep serratus anterior plane block
description: Deposition of local anaesthetic in the space between the serratus anterior muscle and the external intercostal muscle, at the level of the 4th-5th rib, in the midaxillary line. Procedure performed under ultrasound guidance. Catheter - based infusion of local anaesthetic into this space for 48 hours.
arm group label: Deep serratus anterior plane block
intervention type: Procedure
intervention name: Surgically-placed paravertebral block
description: Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.
arm group label: Surgically-placed paravertebral block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Conor Hearty, FFPMCAI,FFPMANZCA,FCARCSI,FIPP
role: Principal Investigator
affiliation: Consultant Anaesthetist, Mater Misericordiae University Hospital
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: Mater Misericordiae University Hospital
investigator full name: Dr Conor Hearty
investigator title: Consultant Anaesthetist
mesh term: Thoracic Diseases
mesh term: Pain, Postoperative
mesh term: Pain, Procedural
mesh term: Rib Fractures
submitted: February 3, 2021
returned: February 23, 2021
submitted: April 13, 2021
returned: May 7, 2021