<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/NCT03768440</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00030317</org_study_id>
    <nct_id>NCT03768440</nct_id>
  </id_info>
  <brief_title>Continuous Erector Spinae Block Versus Continuous Paravertebral Block</brief_title>
  <official_title>Continuous Erector Spinae Block Versus Continuous Paravertebral Block Following Thoracotomy: A Randomized, Controlled Non-Inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overall Aim: To evaluate the efficacy of continuous erector spinae block (ESB) versus&#xD;
      continuous paravertebral block (PVB) for postoperative analgesia in children and adolescents&#xD;
      undergoing surgical procedures via unilateral thoracotomy.&#xD;
&#xD;
      Hypothesis: The investigators hypothesize that ESP block efficacy is not inferior to that of&#xD;
      PVB with respect to pain control and consumed opiate equivalents at 24 hours postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving&#xD;
      subfield of anesthesia practice driven with considerable urgency by the growing recognition&#xD;
      that even appropriate perioperative narcotic administration can have significant derogatory&#xD;
      long-term effects.&#xD;
&#xD;
      Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with&#xD;
      minimal additional patient risk and have become routine components of opioid-sparing&#xD;
      intraoperative and postoperative pain management plans for surgical patients at BCH. In&#xD;
      addition to the postulated benefit of reducing overall opioid exposure and potentially&#xD;
      reducing the risk for long term physiologic and behavioral dependence upon opioids, regional&#xD;
      anesthetics may allow for earlier extubation after selected surgeries, shorter ICU, PACU and&#xD;
      inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and&#xD;
      improved patient satisfaction scores.&#xD;
&#xD;
      Given the rapid evolution of the field of regional anesthesia and the fact that there are&#xD;
      often multiple approaches for achieving analgesia in a select set of dermatomes, there are&#xD;
      often a variety of regional anesthetic options for any given surgery. Some approaches are&#xD;
      longstanding and well-studied, but with increasing frequency since the advent of ultrasound&#xD;
      guidance, newer, novel nerve block options exist. As it is often expensive and work-intensive&#xD;
      to thoroughly evaluate a given regional technique with a controlled pediatric trial, many of&#xD;
      these blocks become standards of practice based on anecdote, retrospective analysis, or&#xD;
      simply belief in the putative benefits of regional anesthetics.&#xD;
&#xD;
      The investigators are fortunate at BCH to have one of the largest concentrated pediatric&#xD;
      surgical populations in the US. They also have an active, and well organized regional&#xD;
      anesthesia service. Because of this, the investigators are in a unique position to more&#xD;
      thoroughly evaluate the effectiveness and safety of regional anesthesia in children.&#xD;
      Furthermore, the investigators feel it is critical that institutions such as BCH take a&#xD;
      leading role in documenting the effects of regional anesthesia on the most important outcome&#xD;
      measures when considering perioperative medicine. These include overall pain management,&#xD;
      surgical healing, functional recovery, long-term pain symptoms, and emotional/behavioral&#xD;
      outcomes after surgery.&#xD;
&#xD;
      Recently the ESB has become popular for providing analgesia after a number of anterior chest&#xD;
      and abdominal procedures. This is a simple interfascial plane block that can reliably provide&#xD;
      unilateral chest and/or abdominal wall analgesia. It has been described in numerous case&#xD;
      reports and one case series as an effective block for management of unilateral thoracotomies,&#xD;
      unilateral rib fractures, unilateral abdominal incisions and (when used bilaterally) for&#xD;
      management of post-sternotomy pain.&#xD;
&#xD;
      As an interfascial plane block in a compressible anatomical space, the ESB is thought to be&#xD;
      safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred&#xD;
      anesthetic option for these patients as opposed to neuraxial (e.g. epidural) and&#xD;
      paraneuraxial (i.e. paravertebral) nerve blocks.&#xD;
&#xD;
      Given the ESB's potentially favorable risk profile versus the other blocks (it is technically&#xD;
      less challenging, more distant from critical structures, and thought to be safe in&#xD;
      anticoagulated patients) it could provide both a safer and easier to perform regional&#xD;
      anesthesia option for many patients. It also offers a new option for a subset of&#xD;
      anticoagulated patients for whom other regional techniques (epidural, paravertebral) are&#xD;
      contraindicated.&#xD;
&#xD;
      Indeed, given the current information available related to the ESB, the regional anesthesia&#xD;
      service at BCH has begun employing it when possible in circumstances where a PVB would&#xD;
      commonly be used but is relatively or absolutely contraindicated. Patients undergoing&#xD;
      thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have&#xD;
      been successfully managed with continuous ESBs. In addition, thoracotomies in patients with&#xD;
      acquired (e.g. dilutional) and other pathologic coagulopathies have been managed with ESBs.&#xD;
      As such, the ESB has been adopted for routine use in specific patient populations at BCH and&#xD;
      has even occasionally been utilized in lieu of the more longstanding routine PVBs or epidural&#xD;
      blocks for patients without contraindication for such.&#xD;
&#xD;
      Retrospective review of BCH outcomes data for 47 ESBs done for a variety of surgeries and&#xD;
      populations has not revealed any significant differences between PVBs and ESBs in terms of&#xD;
      adverse events, postoperative opiate use, median pain scores, or other standard outcomes&#xD;
      measures. As this data is observational in nature, it is difficult to draw firm conclusions&#xD;
      as to the comparative efficacy of the two blocks. However, since there are differences in&#xD;
      technical difficulty, relative contraindications, and there exist populations that might&#xD;
      benefit from these blocks, it would be prudent to comparatively evaluate these blocks in a&#xD;
      controlled, randomized, trial.&#xD;
&#xD;
      The investigators propose to evaluate the comparative efficacy of ESBs and PVBs for patients&#xD;
      undergoing unilateral non-cardiac thoracotomy by means of a randomized, controlled&#xD;
      non-inferiority study (based on a threshold of clinical significance being defined as a 15%&#xD;
      difference) comparing rescue analgesic requirements, rendered as opiate equivalents, at 24&#xD;
      postoperatively. Rescue opiates will be available as needed by means of standard PCA/NCA&#xD;
      demand protocols. Secondary measures will include rescue opiate requirements at 48 and 72&#xD;
      hours, pain scores, adverse events, time to discharge from the ICU, time to extubation,&#xD;
      patient disposition after surgery, and time to perform the block in the operating room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 16, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rescue analgesic consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>24, 48 and 72 hours</time_frame>
    <description>Pain scores measured by the numeric rating scale (NRS: 0/none -&gt; 10/worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to perform the block in the operating room</measure>
    <time_frame>1 hour</time_frame>
    <description>Total time required for intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse events</measure>
    <time_frame>1 week</time_frame>
    <description>Any intervention related (or unrelated) adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesic consumption</measure>
    <time_frame>48 hours</time_frame>
    <description>rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesic consumption</measure>
    <time_frame>72 hours</time_frame>
    <description>rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>continuous erector spinae block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continuous paravertebral block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>continuous erector spinae block (ESB)</intervention_name>
    <description>Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.</description>
    <arm_group_label>continuous erector spinae block</arm_group_label>
    <other_name>ESB with ropivacaine</other_name>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>continuous paravertebral block (PVB)</intervention_name>
    <description>The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.</description>
    <arm_group_label>continuous paravertebral block</arm_group_label>
    <other_name>PVB with ropivacaine</other_name>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)</description>
    <arm_group_label>continuous erector spinae block</arm_group_label>
    <arm_group_label>continuous paravertebral block</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I - III status, undergoing unilateral thoracotomy for either esophageal atresia&#xD;
             related intrathoracic procedures or other non-cardiac general surgical intrathoracic&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing procedures including pleurodesis, pleural stripping, and&#xD;
             decortication or other procedures with widely distributed pleural disruption.&#xD;
&#xD;
          -  Patients with severe neurodevelopmental delays.&#xD;
&#xD;
          -  Patients with previous chronic pain syndromes.&#xD;
&#xD;
          -  Patients with a history of opioid treatment at any point in the 2 months prior to&#xD;
             surgery.&#xD;
&#xD;
          -  Lack of parental consent and/or child assent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ROLAND BRUSSEAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ROLAND BRUSSEAU, MD</last_name>
    <phone>8572184814</phone>
    <email>roland.brusseau@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children&quot;S Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ROLAND BRUSSEAU, MD</last_name>
      <phone>857-218-4814</phone>
      <email>roland.brusseau@childrens.harvard.du</email>
    </contact>
    <contact_backup>
      <last_name>WALID ALRAYASHI, MD</last_name>
      <phone>617-355-2604</phone>
      <email>walid.alrayashi@childrens.harvard.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Rachel Bernier, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jocelyn Booth, BSN-RN</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hanna Van Pelt, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 16, 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>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Roland Brusseau</investigator_full_name>
    <investigator_title>Associate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Havard Medical School</investigator_title>
  </responsible_party>
  <keyword>ropivacaine infusion</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>paravertebral block</keyword>
  <keyword>erector spinae block</keyword>
  <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>Ropivacaine</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/NCT03768440
org study id: IRB-P00030317
nct id: NCT03768440
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Overall Aim: To evaluate the efficacy of continuous erector spinae block (ESB) versus
      continuous paravertebral block (PVB) for postoperative analgesia in children and adolescents
      undergoing surgical procedures via unilateral thoracotomy.

      Hypothesis: The investigators hypothesize that ESP block efficacy is not inferior to that of
      PVB with respect to pain control and consumed opiate equivalents at 24 hours postoperatively.
Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving
      subfield of anesthesia practice driven with considerable urgency by the growing recognition
      that even appropriate perioperative narcotic administration can have significant derogatory
      long-term effects.

      Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with
      minimal additional patient risk and have become routine components of opioid-sparing
      intraoperative and postoperative pain management plans for surgical patients at BCH. In
      addition to the postulated benefit of reducing overall opioid exposure and potentially
      reducing the risk for long term physiologic and behavioral dependence upon opioids, regional
      anesthetics may allow for earlier extubation after selected surgeries, shorter ICU, PACU and
      inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and
      improved patient satisfaction scores.

      Given the rapid evolution of the field of regional anesthesia and the fact that there are
      often multiple approaches for achieving analgesia in a select set of dermatomes, there are
      often a variety of regional anesthetic options for any given surgery. Some approaches are
      longstanding and well-studied, but with increasing frequency since the advent of ultrasound
      guidance, newer, novel nerve block options exist. As it is often expensive and work-intensive
      to thoroughly evaluate a given regional technique with a controlled pediatric trial, many of
      these blocks become standards of practice based on anecdote, retrospective analysis, or
      simply belief in the putative benefits of regional anesthetics.

      The investigators are fortunate at BCH to have one of the largest concentrated pediatric
      surgical populations in the US. They also have an active, and well organized regional
      anesthesia service. Because of this, the investigators are in a unique position to more
      thoroughly evaluate the effectiveness and safety of regional anesthesia in children.
      Furthermore, the investigators feel it is critical that institutions such as BCH take a
      leading role in documenting the effects of regional anesthesia on the most important outcome
      measures when considering perioperative medicine. These include overall pain management,
      surgical healing, functional recovery, long-term pain symptoms, and emotional/behavioral
      outcomes after surgery.

      Recently the ESB has become popular for providing analgesia after a number of anterior chest
      and abdominal procedures. This is a simple interfascial plane block that can reliably provide
      unilateral chest and/or abdominal wall analgesia. It has been described in numerous case
      reports and one case series as an effective block for management of unilateral thoracotomies,
      unilateral rib fractures, unilateral abdominal incisions and (when used bilaterally) for
      management of post-sternotomy pain.

      As an interfascial plane block in a compressible anatomical space, the ESB is thought to be
      safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred
      anesthetic option for these patients as opposed to neuraxial (e.g. epidural) and
      paraneuraxial (i.e. paravertebral) nerve blocks.

      Given the ESB's potentially favorable risk profile versus the other blocks (it is technically
      less challenging, more distant from critical structures, and thought to be safe in
      anticoagulated patients) it could provide both a safer and easier to perform regional
      anesthesia option for many patients. It also offers a new option for a subset of
      anticoagulated patients for whom other regional techniques (epidural, paravertebral) are
      contraindicated.

      Indeed, given the current information available related to the ESB, the regional anesthesia
      service at BCH has begun employing it when possible in circumstances where a PVB would
      commonly be used but is relatively or absolutely contraindicated. Patients undergoing
      thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have
      been successfully managed with continuous ESBs. In addition, thoracotomies in patients with
      acquired (e.g. dilutional) and other pathologic coagulopathies have been managed with ESBs.
      As such, the ESB has been adopted for routine use in specific patient populations at BCH and
      has even occasionally been utilized in lieu of the more longstanding routine PVBs or epidural
      blocks for patients without contraindication for such.

      Retrospective review of BCH outcomes data for 47 ESBs done for a variety of surgeries and
      populations has not revealed any significant differences between PVBs and ESBs in terms of
      adverse events, postoperative opiate use, median pain scores, or other standard outcomes
      measures. As this data is observational in nature, it is difficult to draw firm conclusions
      as to the comparative efficacy of the two blocks. However, since there are differences in
      technical difficulty, relative contraindications, and there exist populations that might
      benefit from these blocks, it would be prudent to comparatively evaluate these blocks in a
      controlled, randomized, trial.

      The investigators propose to evaluate the comparative efficacy of ESBs and PVBs for patients
      undergoing unilateral non-cardiac thoracotomy by means of a randomized, controlled
      non-inferiority study (based on a threshold of clinical significance being defined as a 15%
      difference) comparing rescue analgesic requirements, rendered as opiate equivalents, at 24
      postoperatively. Rescue opiates will be available as needed by means of standard PCA/NCA
      demand protocols. Secondary measures will include rescue opiate requirements at 48 and 72
      hours, pain scores, adverse events, time to discharge from the ICU, time to extubation,
      patient disposition after surgery, and time to perform the block in the operating room.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Rescue analgesic consumption
time frame: 24 hours
description: rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
measure: Pain scores
time frame: 24, 48 and 72 hours
description: Pain scores measured by the numeric rating scale (NRS: 0/none -> 10/worst)
measure: Time to perform the block in the operating room
time frame: 1 hour
description: Total time required for intervention
measure: Number of Adverse events
time frame: 1 week
description: Any intervention related (or unrelated) adverse events
measure: Rescue analgesic consumption
time frame: 48 hours
description: rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
measure: Rescue analgesic consumption
time frame: 72 hours
description: rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
arm group label: continuous erector spinae block
arm group type: Experimental
description: An erector spinae block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
arm group label: continuous paravertebral block
arm group type: Active Comparator
description: A paravertebral block is placed at end of the thoracotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
intervention type: Procedure
intervention name: continuous erector spinae block (ESB)
description: Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
arm group label: continuous erector spinae block
other name: ESB with ropivacaine
other name: Naropin
intervention type: Procedure
intervention name: continuous paravertebral block (PVB)
description: The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
arm group label: continuous paravertebral block
other name: PVB with ropivacaine
other name: Naropin
intervention type: Drug
intervention name: Ropivacaine
description: Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
arm group label: continuous erector spinae block
arm group label: continuous paravertebral block
other name: Naropin
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ROLAND BRUSSEAU, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: ROLAND BRUSSEAU, MD
phone: 8572184814
email: roland.brusseau@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Roland Brusseau
investigator title: Associate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Havard Medical School
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No