xml: <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/NCT06002152</url>
    </required_header>
    <id_info>
      <org_study_id>2000035991</org_study_id>
      <nct_id>NCT06002152</nct_id>
    </id_info>
    <brief_title>Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy</brief_title>
    <acronym>QoR-SCPB</acronym>
    <official_title>Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale University</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn whether a superficial cervical plexus block&#xD;
        improves quality of recovery after thyroid surgery. Investigators will compare a superficial&#xD;
        cervical plexus block with bupivacaine compared to an identical procedure performed saline&#xD;
        placebo to see if there is a difference in quality of recovery on the first postoperative&#xD;
        day.&#xD;
  &#xD;
        The main question to answer is:&#xD;
  &#xD;
        • Does a superficial cervical plexus block with bupivacaine compared to placebo improve&#xD;
        quality of recovery in patients having thyroid surgery.&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Fill out an initial preoperative survey&#xD;
  &#xD;
          -  Be randomized to receive a superficial cervical plexus block with bupivacaine or saline&#xD;
             placebo while under anesthesia before the surgery starts&#xD;
  &#xD;
          -  Fill out a survey about recovery on the first day after surgery&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Thyroid surgery is associated with mild to moderate post-operative pain, with most patients&#xD;
        requiring opioid pain medicine postoperatively. Nerve blocks, such as the superficial&#xD;
        cervical plexus block, are an important component of pain control plans. Superficial cervical&#xD;
        plexus blocks have been proven to decrease pain and reduce the need for opioid medications in&#xD;
        thyroid surgery. However, previous studies were performed before it became common practice to&#xD;
        administer a combination of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and&#xD;
        steroids for thyroid surgery which also help with pain. Whether the superficial cervical&#xD;
        plexus block improves pain control and quality of recovery in this context is unknown. This&#xD;
        study aims to determine whether the superficial cervical plexus block has an impact on&#xD;
        quality of recovery as measured by a survey called the Quality of Recovery-40 (QoR-40).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 2</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>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1</measure>
      <time_frame>Up to 2 days</time_frame>
      <description>The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions.&#xD;
  The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery.&#xD;
  Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices.&#xD;
  Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Opioid consumption postoperatively</measure>
      <time_frame>Up to 2 days</time_frame>
      <description>This outcome will be measured in morphine milligram equivalents. The data will be obtained from electronic medical record (EMR) review. It will be measured from the start of the participant's post-anesthesia care unit (PACU) stay and through POD 1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for rescue analgesia prior to PACU discharge</measure>
      <time_frame>approximately 4 hours</time_frame>
      <description>This outcome will be measured as &quot;Yes&quot; or &quot;No&quot;. The data will be obtained from EMR review from the start of participant's PACU stay to end of participant's PACU stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of nausea and/or vomiting in the PACU</measure>
      <time_frame>approximately 4 hours</time_frame>
      <description>This outcome will be measured as &quot;Yes&quot; or &quot;No&quot;. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for rescue antiemetics in PACU</measure>
      <time_frame>approximately 4 hours</time_frame>
      <description>This outcome will be measured as &quot;Yes&quot; or &quot;No&quot;. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PACU length of stay</measure>
      <time_frame>approximately 4 hours</time_frame>
      <description>This outcome will be measured in minutes. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of patient reported side effects</measure>
      <time_frame>up to 2 days</time_frame>
      <description>Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient reported quantity of other modes of analgesia, if any through POD 1</measure>
      <time_frame>up to 2 days</time_frame>
      <description>Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Bupivacaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine</intervention_name>
      <description>After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of 0.25% bupivacaine on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.</description>
      <arm_group_label>Bupivacaine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of saline on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 years or older&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status classification I-III&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Scheduled for thyroid surgery&#xD;
  &#xD;
            -  Access to smartphone device or computer with internet connection and has an email&#xD;
               address&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status classification &gt; III&#xD;
  &#xD;
            -  Have an intolerance or contraindication to the medications involved in the study&#xD;
  &#xD;
            -  Undergoing repeat thyroid surgery&#xD;
  &#xD;
            -  Undergoing surgery with planned neck dissection&#xD;
  &#xD;
            -  Plan for admission post-operatively&#xD;
  &#xD;
            -  Positive pregnancy test on day of surgery (for participants with child-bearing&#xD;
               potential)&#xD;
  &#xD;
            -  Refusal to participate&#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_contact>
      <last_name>Jaime Hyman, MD</last_name>
      <phone>203-785-2802</phone>
      <email>jaime.hyman@yale.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anita M Jegarl, BS</last_name>
      <phone>203-785-2802</phone>
      <email>anita.jegarl@yale.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Superficial Cervical Plexus Block</keyword>
    <keyword>Quality of Recovery</keyword>
    <keyword>Postoperative Pain</keyword>
    <keyword>Thyroidectomy</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>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002152
  org study id: 2000035991
  nct id: NCT06002152
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to learn whether a superficial cervical plexus block
        improves quality of recovery after thyroid surgery. Investigators will compare a superficial
        cervical plexus block with bupivacaine compared to an identical procedure performed saline
        placebo to see if there is a difference in quality of recovery on the first postoperative
        day.
  
        The main question to answer is:
  
        • Does a superficial cervical plexus block with bupivacaine compared to placebo improve
        quality of recovery in patients having thyroid surgery.
  
        Participants will:
  
          -  Fill out an initial preoperative survey
  
          -  Be randomized to receive a superficial cervical plexus block with bupivacaine or saline
             placebo while under anesthesia before the surgery starts
  
          -  Fill out a survey about recovery on the first day after surgery
  Thyroid surgery is associated with mild to moderate post-operative pain, with most patients
        requiring opioid pain medicine postoperatively. Nerve blocks, such as the superficial
        cervical plexus block, are an important component of pain control plans. Superficial cervical
        plexus blocks have been proven to decrease pain and reduce the need for opioid medications in
        thyroid surgery. However, previous studies were performed before it became common practice to
        administer a combination of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and
        steroids for thyroid surgery which also help with pain. Whether the superficial cervical
        plexus block improves pain control and quality of recovery in this context is unknown. This
        study aims to determine whether the superficial cervical plexus block has an impact on
        quality of recovery as measured by a survey called the Quality of Recovery-40 (QoR-40).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1
  time frame: Up to 2 days
  description: The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions.
  The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery.
  Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices.
  Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.
  measure: Opioid consumption postoperatively
  time frame: Up to 2 days
  description: This outcome will be measured in morphine milligram equivalents. The data will be obtained from electronic medical record (EMR) review. It will be measured from the start of the participant's post-anesthesia care unit (PACU) stay and through POD 1.
  measure: Need for rescue analgesia prior to PACU discharge
  time frame: approximately 4 hours
  description: This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review from the start of participant's PACU stay to end of participant's PACU stay
  measure: Presence of nausea and/or vomiting in the PACU
  time frame: approximately 4 hours
  description: This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
  measure: Need for rescue antiemetics in PACU
  time frame: approximately 4 hours
  description: This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
  measure: PACU length of stay
  time frame: approximately 4 hours
  description: This outcome will be measured in minutes. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
  measure: Presence of patient reported side effects
  time frame: up to 2 days
  description: Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.
  measure: Patient reported quantity of other modes of analgesia, if any through POD 1
  time frame: up to 2 days
  description: Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.
  arm group label: Bupivacaine
  arm group type: Experimental
  description: Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
  intervention type: Drug
  intervention name: Bupivacaine
  description: After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of 0.25% bupivacaine on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
  arm group label: Bupivacaine
  intervention type: Drug
  intervention name: Placebo
  description: After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of saline on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jaime Hyman, MD
  phone: 203-785-2802
  email: jaime.hyman@yale.edu
  last name: Anita M Jegarl, BS
  phone: 203-785-2802
  email: anita.jegarl@yale.edu
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Bupivacaine
  sharing ipd: No