<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/NCT03269890</url>
  </required_header>
  <id_info>
    <org_study_id>MS/17.03.138</org_study_id>
    <nct_id>NCT03269890</nct_id>
  </id_info>
  <brief_title>The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks</brief_title>
  <official_title>The Efficacy of Intermediate Cervical Plexus Block Versus Cutaneous and Thyroid Capsular Blocks in Thyroid Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thyroid gland surgery is one of the most commonly performed operations for either benign or&#xD;
      malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be&#xD;
      treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects,&#xD;
      including postoperative nausea and vomiting, which are frequent after this type of procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional techniques of anesthesia may help to decrease post-operative pain and reduce&#xD;
      systemic analgesic requirement. Classically, the cervical plexus is considered to have two&#xD;
      distributions, the superficial cutaneous and the deep motor nerves.&#xD;
&#xD;
      Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely&#xD;
      to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by&#xD;
      the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the&#xD;
      thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the&#xD;
      potential space called the capsule-sheath space is formed. It contains also loose connective&#xD;
      tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would&#xD;
      block the surface of thyroid gland and permeate directly into the parenchyma producing&#xD;
      effective local anesthesia for thyroid surgical procedures. It is supposed also to involve&#xD;
      autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a&#xD;
      subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance&#xD;
      effective local anesthesia for the initial skin incision and further contribute to a more&#xD;
      ideal working environment for the surgeon. Therefore, anesthetic technique termed&#xD;
      ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous&#xD;
      nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .&#xD;
&#xD;
      Our hypothesis is that a combination of simple dual techniques including superficial&#xD;
      cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford&#xD;
      autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus&#xD;
      block may provide these blocks but using a machine and deep penetration possibly involving&#xD;
      unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique&#xD;
      can provide the same intra and postoperative anesthetic conditions it will be preferred.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total dose of opioid analgesics used</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>The total dose of opioid analgesics required in the post-operative periods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first analgesic request</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Time to first request for a rescue analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fentanyl use</measure>
    <time_frame>For 5 hours after start of anaesthesia</time_frame>
    <description>Intraoperative use of fentanyl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rocuronium use</measure>
    <time_frame>For 5 hours after start of anaesthesia</time_frame>
    <description>Intraoperative use of rocuronium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory blockade</measure>
    <time_frame>for 1 hour after surgery</time_frame>
    <description>Assessment of sensory blockade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diaphragmatic dysfunction</measure>
    <time_frame>for 5 hours after performing blockade</time_frame>
    <description>Diaphragmatic dysfunction using ultrasound assessment and possible x ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation score</measure>
    <time_frame>for 5 hours after performing blockade</time_frame>
    <description>Sedation score using Modified Ramsay scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>for 24 hrs after surgery</time_frame>
    <description>Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative headache</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hoarseness of voice</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dysphagia</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory difficulty</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Peripheral oxygen saturation less than 92%</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Thyroid Surgery</condition>
  <arm_group>
    <arm_group_label>Capsule and cutaneous blocks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>US-intermediate cervical plexus block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsule and cutaneous blocks</intervention_name>
    <description>7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side</description>
    <arm_group_label>Capsule and cutaneous blocks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>US-intermediate cervical plexus block</intervention_name>
    <description>15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.</description>
    <arm_group_label>US-intermediate cervical plexus block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status grade I and grade II.&#xD;
&#xD;
          -  Euthyroidism after thyroid function tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Thyroid gland more than 5 cm size.&#xD;
&#xD;
          -  Retrosternal extension.&#xD;
&#xD;
          -  Planned block neck dissection.&#xD;
&#xD;
          -  Neuromuscular diseases&#xD;
&#xD;
          -  Hematological diseases.&#xD;
&#xD;
          -  Bleeding diseases.&#xD;
&#xD;
          -  Coagulation abnormality.&#xD;
&#xD;
          -  Psychiatric diseases.&#xD;
&#xD;
          -  Drug abuse.&#xD;
&#xD;
          -  Local skin infection&#xD;
&#xD;
          -  sepsis at site of the block.&#xD;
&#xD;
          -  Known intolerance to the study drugs.&#xD;
&#xD;
          -  Body Mass Index &gt; 40 Kg/m2.&#xD;
&#xD;
          -  Known diaphragmatic motion abnormalities&#xD;
&#xD;
          -  major respiratory disease.&#xD;
&#xD;
          -  Previous history of cervical surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moneir O El-Hefny, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oncolgy Center, Mansoura University,</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>53316</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 19, 2020</last_update_submitted>
  <last_update_submitted_qc>September 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03269890
org study id: MS/17.03.138
nct id: NCT03269890
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Thyroid gland surgery is one of the most commonly performed operations for either benign or
      malignant pathologies Pain related to thyroid surgery is of moderate intensity .which may be
      treated with NSAIDs or opioids. However, Opioids have many well-known undesirable effects,
      including postoperative nausea and vomiting, which are frequent after this type of procedure.
Regional techniques of anesthesia may help to decrease post-operative pain and reduce
      systemic analgesic requirement. Classically, the cervical plexus is considered to have two
      distributions, the superficial cutaneous and the deep motor nerves.

      Anatomically, the thyroid gland has an inner true capsule which is thin and adheres closely
      to the thyroidal tissue [Fancy et al., 2010]. External to this is a false capsule formed by
      the middle layer of the deep cervical fascia, which splits anterolaterally to ensheathe the
      thyroid gland, thus forming the thyroid sheath [Bliss et al., 2000]. In this fashion, the
      potential space called the capsule-sheath space is formed. It contains also loose connective
      tissue, blood vessels, nerves and parathyroid gland. Anesthetic deposited in this space would
      block the surface of thyroid gland and permeate directly into the parenchyma producing
      effective local anesthesia for thyroid surgical procedures. It is supposed also to involve
      autonomic nerve block of the thyroid gland [Fliers et al., 2010]. Additionally, a
      subcutaneous injection along the sternocleidomastoid muscle (SCM) would also enhance
      effective local anesthesia for the initial skin incision and further contribute to a more
      ideal working environment for the surgeon. Therefore, anesthetic technique termed
      ultrasound-guided capsule-sheath space block (CSSB) combined with anterior cervical cutaneous
      nerves block (CCNB) for thyroidectomy is done [Wang et al., 2015] .

      Our hypothesis is that a combination of simple dual techniques including superficial
      cutaneous block to provide sensory blockade, and surgeon mediated capsular block may afford
      autonomic thyroid blockade. In comparison, ultrasound guided intermediate cervical plexus
      block may provide these blocks but using a machine and deep penetration possibly involving
      unwanted blocks for phrenic and recurrent laryngeal nerves. So, if the simple safe technique
      can provide the same intra and postoperative anesthetic conditions it will be preferred.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Total dose of opioid analgesics used
time frame: For 24 hours after surgery
description: The total dose of opioid analgesics required in the post-operative periods
measure: Postoperative pain
time frame: For 24 hours after surgery
description: Postoperative visual analogue score (VAS) (0 no pain -10 worst imaginable pain),
measure: Time to first analgesic request
time frame: For 24 hours after surgery
description: Time to first request for a rescue analgesic
measure: Fentanyl use
time frame: For 5 hours after start of anaesthesia
description: Intraoperative use of fentanyl
measure: Rocuronium use
time frame: For 5 hours after start of anaesthesia
description: Intraoperative use of rocuronium
measure: Sensory blockade
time frame: for 1 hour after surgery
description: Assessment of sensory blockade
measure: Diaphragmatic dysfunction
time frame: for 5 hours after performing blockade
description: Diaphragmatic dysfunction using ultrasound assessment and possible x ray
measure: Sedation score
time frame: for 5 hours after performing blockade
description: Sedation score using Modified Ramsay scale
measure: Patient satisfaction
time frame: for 24 hrs after surgery
description: Patient satisfaction regards analgesia using a score of (0-10) with 10 represents the highest satisfaction
measure: Postoperative nausea and vomiting
time frame: For 24 hours after surgery
description: frequency
measure: Postoperative headache
time frame: For 24 hours after surgery
description: frequency
measure: Hoarseness of voice
time frame: For 24 hours after surgery
description: frequency
measure: Dysphagia
time frame: For 24 hours after surgery
description: frequency
measure: Respiratory difficulty
time frame: For 24 hours after surgery
description: Peripheral oxygen saturation less than 92%
arm group label: Capsule and cutaneous blocks
arm group type: Experimental
description: 7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks per side. once before surgery
arm group label: US-intermediate cervical plexus block
arm group type: Active Comparator
description: 15 mL of 0.5% isobaric bupivacaine + Epinephrine 5 microgram/ ml. per side. once before surgery
intervention type: Procedure
intervention name: Capsule and cutaneous blocks
description: 7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
arm group label: Capsule and cutaneous blocks
intervention type: Procedure
intervention name: US-intermediate cervical plexus block
description: 15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.
arm group label: US-intermediate cervical plexus block
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Moneir O El-Hefny, MD
role: Study Chair
affiliation: Professor of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Thyroid Diseases
sharing ipd: Undecided