<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/NCT01662219</url>
  </required_header>
  <id_info>
    <org_study_id>12-0210-A</org_study_id>
    <nct_id>NCT01662219</nct_id>
  </id_info>
  <brief_title>Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery</brief_title>
  <acronym>QoR</acronym>
  <official_title>Effect of Superficial Cervical Plexus Block on the Postoperative Quality of Recovery After Anterior Cervical Discectomy and Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted&#xD;
      as moderate in severity, often needing oral opioid analgesics. In addition, these patients&#xD;
      are more prone for postoperative respiratory complication due to airway edema secondary to&#xD;
      surgical retraction or wound hematoma. Opioid analgesics provide good pain control but&#xD;
      postoperative nausea and vomiting and respiratory depression are undesirable in these&#xD;
      patients who are at risk for postoperative wound hematoma and airway edema The use of&#xD;
      multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after&#xD;
      ambulatory procedures at most surgery centers throughout the world . The purpose of this&#xD;
      study is to determine whether superficial cervical plexus block will improve the&#xD;
      postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire&#xD;
      (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anterior cervical discectomy and fusion is increasingly being done as a day surgery or short&#xD;
      stay surgery. Postoperative pain is the leading cause of unplanned hospital admissions&#xD;
      following day surgery, a major source of dissatisfaction and often impairs the quality of&#xD;
      recovery. Opioid analgesics alone are not always effective and may also worsen the&#xD;
      postoperative nausea and vomiting and in turn the postoperative recovery. This study is&#xD;
      designed to find out if an injection of freezing on the side of neck around the nerves&#xD;
      (superficial cervical plexus block) improves the quality of recovery from anesthesia and&#xD;
      surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery.&#xD;
&#xD;
      Primary Outcome Measure The primary outcome measure is the global QoR-40 aggregate score at&#xD;
      24 hours after surgery.&#xD;
&#xD;
      Secondary Outcome Measures&#xD;
&#xD;
        -  Postoperative pain scores (first 24 hours)&#xD;
&#xD;
        -  Total analgesic consumption (first 24 hours)&#xD;
&#xD;
        -  Time for first opioid administration&#xD;
&#xD;
        -  Postop Nausea and vomiting (first 24 hours)&#xD;
&#xD;
        -  Post operative sedation (first 24 hours)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>post operative pain score assessment</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative analgesic consumption</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time for the first dose of opioid consumption</measure>
    <time_frame>24 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative nausea and vomiting</measure>
    <time_frame>24 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative sedation score</measure>
    <time_frame>24 hrs</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Cervical Disc Prolapse</condition>
  <arm_group>
    <arm_group_label>superficial cervical plexus block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>superficial cervical plexus block for experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Block</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no superficial cervical plexus block for the no intervention group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Superficial cervical plexus block for experimental group</intervention_name>
    <description>15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block</description>
    <arm_group_label>superficial cervical plexus block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all adult patients&#xD;
&#xD;
          -  aged 18-80 years&#xD;
&#xD;
          -  with ASA class I - III&#xD;
&#xD;
          -  undergoing anterior cervical disc surgery in supine position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. In patients who are allergic to local anesthetics&#xD;
&#xD;
          2. ASA- IV patients&#xD;
&#xD;
          3. Lack of informed consent&#xD;
&#xD;
          4. Pregnant patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>lashmikumar venkatraghavan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TWH,UHN,Toronto Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto Western Hospital,UHN.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>February 5, 2018</last_update_submitted>
  <last_update_submitted_qc>February 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Lashmi Venkatraghavan</investigator_full_name>
    <investigator_title>Dr. Lashmikumar Venkatraghavan, Asst. Professor,Dept. of Anesthesia, TWH, UHN,Toronto,ON.</investigator_title>
  </responsible_party>
  <keyword>superficial cervical plexus block</keyword>
  <keyword>quality of recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_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/NCT01662219
org study id: 12-0210-A
nct id: NCT01662219
lead sponsor: 
has dmc: Yes
Pain and discomfort after anterior cervical spine surgery is difficult to quantify and quoted
      as moderate in severity, often needing oral opioid analgesics. In addition, these patients
      are more prone for postoperative respiratory complication due to airway edema secondary to
      surgical retraction or wound hematoma. Opioid analgesics provide good pain control but
      postoperative nausea and vomiting and respiratory depression are undesirable in these
      patients who are at risk for postoperative wound hematoma and airway edema The use of
      multimodal analgesia is rapidly becoming the 'standard of care' for preventing pain after
      ambulatory procedures at most surgery centers throughout the world . The purpose of this
      study is to determine whether superficial cervical plexus block will improve the
      postoperative quality of recovery as measured by Quality of Recovery 40 questionnaire
      (QoR-40) in patients undergoing elective anterior cervical discectomy and fusion.
Anterior cervical discectomy and fusion is increasingly being done as a day surgery or short
      stay surgery. Postoperative pain is the leading cause of unplanned hospital admissions
      following day surgery, a major source of dissatisfaction and often impairs the quality of
      recovery. Opioid analgesics alone are not always effective and may also worsen the
      postoperative nausea and vomiting and in turn the postoperative recovery. This study is
      designed to find out if an injection of freezing on the side of neck around the nerves
      (superficial cervical plexus block) improves the quality of recovery from anesthesia and
      surgery by reducing the pain, analgesic consumption after anterior cervical spine surgery.

      Primary Outcome Measure The primary outcome measure is the global QoR-40 aggregate score at
      24 hours after surgery.

      Secondary Outcome Measures

        -  Postoperative pain scores (first 24 hours)

        -  Total analgesic consumption (first 24 hours)

        -  Time for first opioid administration

        -  Postop Nausea and vomiting (first 24 hours)

        -  Post operative sedation (first 24 hours)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The primary outcome measure is the global QoR-40 aggregate score after ACDF surgery.
time frame: 24 hours
measure: post operative pain score assessment
time frame: 24 hours
measure: Post operative analgesic consumption
time frame: 24 hours
measure: time for the first dose of opioid consumption
time frame: 24 hrs
measure: post operative nausea and vomiting
time frame: 24 hrs
measure: post operative sedation score
time frame: 24 hrs
arm group label: superficial cervical plexus block
arm group type: Experimental
description: superficial cervical plexus block for experimental group
arm group label: No Block
arm group type: No Intervention
description: no superficial cervical plexus block for the no intervention group
intervention type: Other
intervention name: Superficial cervical plexus block for experimental group
description: 15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
arm group label: superficial cervical plexus block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: lashmikumar venkatraghavan, MD
role: Principal Investigator
affiliation: TWH,UHN,Toronto Canada
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Lashmi Venkatraghavan
investigator title: Dr. Lashmikumar Venkatraghavan, Asst. Professor,Dept. of Anesthesia, TWH, UHN,Toronto,ON.
mesh term: Intervertebral Disc Displacement
mesh term: Prolapse