<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/NCT02970097</url>
  </required_header>
  <id_info>
    <org_study_id>825465</org_study_id>
    <nct_id>NCT02970097</nct_id>
  </id_info>
  <brief_title>Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery</brief_title>
  <official_title>Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare infraclavicular brachial plexus shot single shot&#xD;
      block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual&#xD;
      analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours&#xD;
      post operatively will be used for comparison.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If the patient is willing to participate and signs the consent, he/she will be randomized to&#xD;
      one of the two treatment groups:&#xD;
&#xD;
        1. Single shot block&#xD;
&#xD;
        2. Local Infiltration&#xD;
&#xD;
      In the institution investigators usually advocate for regional anesthesia and intravenous&#xD;
      sedation for the repair of open fracture of the distal radius.&#xD;
&#xD;
      Patients will be monitored during block performance with standard ASA monitors. All patients&#xD;
      will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect.&#xD;
      Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.&#xD;
&#xD;
      Block time out will be preformed according to standard operating procedure. All blocks will&#xD;
      be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency&#xD;
      curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and local infiltration&#xD;
      will be performed according to the SOP in the department. Ultrasound survey of the&#xD;
      deltopectoral groove below the clavicle will take place. The axillary artery and the three&#xD;
      cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis&#xD;
      view deeper to the pectoralis minor muscle.&#xD;
&#xD;
      For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced&#xD;
      in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%)&#xD;
      bolus will be used to verify correct placement of the needle in the vicinity of the posterior&#xD;
      cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine&#xD;
      0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus&#xD;
      injection.&#xD;
&#xD;
      For local infiltration: At the end of surgery, surgeon will inject 10 ml of Ropivacaine 0.5%&#xD;
      into the arthroscopy portals and the wrist. Specifically, 1 ml to 2 ml of Ropivacaine 0.5%&#xD;
      will be injected into each portal with the remainder of the volume injected into the joint&#xD;
      space itself.&#xD;
&#xD;
      Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad&#xD;
      in the posterior, medial and lateral cord distribution over the forearm and the hand within&#xD;
      30min after injection. Subjects with successful catheter placement per protocol and nerve&#xD;
      block onset will be retained in the study. Subjects with a failed catheter insertion or&#xD;
      misplaced catheter indicated by a lack of sensory changes will have their catheter replaced&#xD;
      or will be single shot blocked and withdrawn from the study.&#xD;
&#xD;
      Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl&#xD;
      (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50&#xD;
      mcg/kg/min).&#xD;
&#xD;
      All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during&#xD;
      surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of&#xD;
      dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before&#xD;
      recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled&#xD;
      diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250&#xD;
      mg/dl.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    lack of resources&#xD;
  </why_stopped>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Scores as measured by the Visual Analog Scale</measure>
    <time_frame>72 hours</time_frame>
    <description>Pain scores at rest and with movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participants need for pain relief as measured by opiate consumption</measure>
    <time_frame>72 hours</time_frame>
    <description>Amount of opiate consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery score</measure>
    <time_frame>7 days</time_frame>
    <description>Score of QoR survey to determine recovery status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of sleep as measured by modified Pittsburgh Sleep Quality Index</measure>
    <time_frame>72 hours</time_frame>
    <description>a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion as measured by the Disability assessment of shoulder and hand questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Wrist Injuries</condition>
  <condition>Postoperative Pain Control</condition>
  <arm_group>
    <arm_group_label>single shot IBP block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive local infiltration into portal space and joint space with 10ml of 0.5% ropivicaine given intraoperatively to help with operative and postoperative pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20ml bolus of 0.5% ropivicaine</intervention_name>
    <description>local anesthetic</description>
    <arm_group_label>single shot IBP block</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10 ml of 0.5% ropivicaine</intervention_name>
    <description>local anesthetic</description>
    <arm_group_label>local infiltration</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>1-2 mg of medication given intravenously before nerve block</description>
    <arm_group_label>single shot IBP block</arm_group_label>
    <other_name>Versed</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>50-100 mcg of medication given intravenously before nerve block</description>
    <arm_group_label>single shot IBP block</arm_group_label>
    <other_name>Sublimaze</other_name>
    <other_name>Actiq</other_name>
    <other_name>Durogesic</other_name>
    <other_name>Fentora</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for wrist arthroscopy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I -III&#xD;
&#xD;
          -  Mentally competent and able to give consent for enrollment in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient younger than 18 years old&#xD;
&#xD;
          -  Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and&#xD;
             any of the drugs included in the standard of care&#xD;
&#xD;
          -  Patients opting to go under light anesthesia and those refusing the block&#xD;
&#xD;
          -  Chronic pain syndromes; Patients will be defined to have chronic pain if they are&#xD;
             using regular daily doses of systemic narcotics for the past 6 months prior to the&#xD;
             surgery&#xD;
&#xD;
          -  BMI of 40 or more&#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>Nabil Elkassabany, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania, Anesthesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infraclavicular brachial plexus block</keyword>
  <keyword>wrist arthroscopy</keyword>
  <keyword>quality of recovery score</keyword>
  <keyword>pain score</keyword>
  <keyword>modified sleep quality assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wrist Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02970097
org study id: 825465
nct id: NCT02970097
lead sponsor: 
has dmc: No
The purpose of this study is to compare infraclavicular brachial plexus shot single shot
      block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual
      analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours
      post operatively will be used for comparison.
If the patient is willing to participate and signs the consent, he/she will be randomized to
      one of the two treatment groups:

        1. Single shot block

        2. Local Infiltration

      In the institution investigators usually advocate for regional anesthesia and intravenous
      sedation for the repair of open fracture of the distal radius.

      Patients will be monitored during block performance with standard ASA monitors. All patients
      will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect.
      Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

      Block time out will be preformed according to standard operating procedure. All blocks will
      be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency
      curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and local infiltration
      will be performed according to the SOP in the department. Ultrasound survey of the
      deltopectoral groove below the clavicle will take place. The axillary artery and the three
      cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis
      view deeper to the pectoralis minor muscle.

      For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced
      in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%)
      bolus will be used to verify correct placement of the needle in the vicinity of the posterior
      cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine
      0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus
      injection.

      For local infiltration: At the end of surgery, surgeon will inject 10 ml of Ropivacaine 0.5%
      into the arthroscopy portals and the wrist. Specifically, 1 ml to 2 ml of Ropivacaine 0.5%
      will be injected into each portal with the remainder of the volume injected into the joint
      space itself.

      Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad
      in the posterior, medial and lateral cord distribution over the forearm and the hand within
      30min after injection. Subjects with successful catheter placement per protocol and nerve
      block onset will be retained in the study. Subjects with a failed catheter insertion or
      misplaced catheter indicated by a lack of sensory changes will have their catheter replaced
      or will be single shot blocked and withdrawn from the study.

      Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl
      (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50
      mcg/kg/min).

      All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during
      surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of
      dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before
      recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled
      diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250
      mg/dl.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Scores as measured by the Visual Analog Scale
time frame: 72 hours
description: Pain scores at rest and with movement.
measure: Participants need for pain relief as measured by opiate consumption
time frame: 72 hours
description: Amount of opiate consumption
measure: Quality of recovery score
time frame: 7 days
description: Score of QoR survey to determine recovery status
measure: quality of sleep as measured by modified Pittsburgh Sleep Quality Index
time frame: 72 hours
description: a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3
measure: Range of motion as measured by the Disability assessment of shoulder and hand questionnaire
time frame: 3 months
description: Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery
arm group label: single shot IBP block
arm group type: Active Comparator
description: Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain
arm group label: local infiltration
arm group type: Active Comparator
description: Subjects will receive local infiltration into portal space and joint space with 10ml of 0.5% ropivicaine given intraoperatively to help with operative and postoperative pain
intervention type: Drug
intervention name: 20ml bolus of 0.5% ropivicaine
description: local anesthetic
arm group label: single shot IBP block
other name: Naropin
intervention type: Drug
intervention name: 10 ml of 0.5% ropivicaine
description: local anesthetic
arm group label: local infiltration
other name: Naropin
intervention type: Drug
intervention name: Midazolam
description: 1-2 mg of medication given intravenously before nerve block
arm group label: single shot IBP block
other name: Versed
intervention type: Drug
intervention name: Fentanyl
description: 50-100 mcg of medication given intravenously before nerve block
arm group label: single shot IBP block
other name: Sublimaze
other name: Actiq
other name: Durogesic
other name: Fentora
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nabil Elkassabany, MD
role: Principal Investigator
affiliation: University of Pennsylvania, Anesthesia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wrist Injuries
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Ropivacaine