<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/NCT03807505</url>
  </required_header>
  <id_info>
    <org_study_id>48351</org_study_id>
    <nct_id>NCT03807505</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery</brief_title>
  <official_title>Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 goal of this study is the evaluation of erector spinae plane (ESP) blocks as an&#xD;
      alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total&#xD;
      shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are&#xD;
      performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for&#xD;
      total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part&#xD;
      of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The&#xD;
      investigators would like to study whether an ESP block can provide similar pain control&#xD;
      compared to an interscalene nerve block, with less risk of upper extremity motor block and&#xD;
      phrenic nerve block.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 22, 2019</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of diaphragmatic paresis or paralysis</measure>
    <time_frame>Before block placement, and 30 minutes after catheter is bolused in recovery</time_frame>
    <description>Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>48 hours</time_frame>
    <description>Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brachial plexus sensory exam change</measure>
    <time_frame>Before block placement, and 30 minutes after catheter is bolused in recovery</time_frame>
    <description>Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brachial plexus motor exam change</measure>
    <time_frame>Before block placement, and 30 minutes after catheter is bolused in recovery</time_frame>
    <description>Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>48 hours</time_frame>
    <description>Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>72 hours</time_frame>
    <description>Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>72 hours</time_frame>
    <description>Patient satisfaction with the nerve block (dichotomous measure: yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incentive spirometry volume change</measure>
    <time_frame>24 hours</time_frame>
    <description>Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Phrenic Nerve Paralysis</condition>
  <condition>Upper Extremity Injury</condition>
  <condition>Shoulder Injury</condition>
  <arm_group>
    <arm_group_label>Interscalene nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erector Spinae Plane block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interscalene brachial plexus nerve block</intervention_name>
    <description>An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.</description>
    <arm_group_label>Interscalene nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae plane block</intervention_name>
    <description>An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.</description>
    <arm_group_label>Erector Spinae Plane block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All adult patients (18 years and over) scheduled for rotator cuff surgery or total&#xD;
        shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant life-threatening injuries and other concomitant injuries causing&#xD;
             significant pain.&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  any condition impairing patient's ability to consent to participation in study&#xD;
&#xD;
          -  an existing condition contraindicating a nerve block, i.e. nerve injury, existing&#xD;
             bleeding disorder&#xD;
&#xD;
          -  infection in the vicinity of the block, and patient refusal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ban Tsui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Health Care (SHC)</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.</citation>
    <PMID>2006740</PMID>
  </reference>
  <reference>
    <citation>Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.</citation>
    <PMID>18682410</PMID>
  </reference>
  <reference>
    <citation>Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.</citation>
    <PMID>30292068</PMID>
  </reference>
  <reference>
    <citation>Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.</citation>
    <PMID>29868941</PMID>
  </reference>
  <reference>
    <citation>Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.</citation>
    <PMID>29134518</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Chi-Ho Ban Tsui</investigator_full_name>
    <investigator_title>Professor of Anesthesiology, Perioperative and Pain Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Shoulder Injuries</mesh_term>
    <mesh_term>Arm Injuries</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/NCT03807505
org study id: 48351
nct id: NCT03807505
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an
      alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total
      shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are
      performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for
      total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part
      of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The
      investigators would like to study whether an ESP block can provide similar pain control
      compared to an interscalene nerve block, with less risk of upper extremity motor block and
      phrenic nerve block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Incidence of diaphragmatic paresis or paralysis
time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
description: Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery
measure: Pain score
time frame: 48 hours
description: Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).
measure: Brachial plexus sensory exam change
time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
description: Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes
measure: Brachial plexus motor exam change
time frame: Before block placement, and 30 minutes after catheter is bolused in recovery
description: Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance
measure: Opioid Consumption
time frame: 48 hours
description: Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded
measure: Adverse effects
time frame: 72 hours
description: Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block
measure: Patient satisfaction
time frame: 72 hours
description: Patient satisfaction with the nerve block (dichotomous measure: yes/no)
measure: Incentive spirometry volume change
time frame: 24 hours
description: Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.
arm group label: Interscalene nerve block
arm group type: Active Comparator
description: Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.
arm group label: Erector Spinae Plane block
arm group type: Active Comparator
description: Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.
intervention type: Procedure
intervention name: Interscalene brachial plexus nerve block
description: An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
arm group label: Interscalene nerve block
intervention type: Procedure
intervention name: Erector spinae plane block
description: An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
arm group label: Erector Spinae Plane block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ban Tsui, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PMID: 2006740
citation: Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
PMID: 18682410
citation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PMID: 30292068
citation: Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
PMID: 29868941
citation: Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
PMID: 29134518
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Chi-Ho Ban Tsui
investigator title: Professor of Anesthesiology, Perioperative and Pain Medicine
mesh term: Paralysis
mesh term: Wounds and Injuries
mesh term: Shoulder Injuries
mesh term: Arm Injuries
sharing ipd: No