<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/NCT04442009</url>
  </required_header>
  <id_info>
    <org_study_id>Medipol Hospital 15</org_study_id>
    <nct_id>NCT04442009</nct_id>
  </id_info>
  <brief_title>Superficial Cervical Plexus Block for Orthognathic Surgery</brief_title>
  <official_title>Ultrasound-guided Superficial Cervical Plexus Block for Pain Management After Orthognathic Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medipol University</source>
  <oversight_info>
    <has_dmc>No</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>
      US-guided superficial cervical plexus block (SCPB) may be used for several head and neck&#xD;
      surgeries. Local anesthetic is injected under the sternocleidomastoid muscle for SCPB. It has&#xD;
      lower complication rate compared to the deep cervical plexus block. Postoperative pain&#xD;
      management is important in patients underwent orthognathic surgery. Effective pain treatment&#xD;
      provides early mobilization, and shorter hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain management is very important in patients underwent orthognathic surgery.&#xD;
      Effective pain control provides early mobilization, shorter hospital stay and it increases&#xD;
      the satisfaction of the patients. Opioid agents may provide effective pain management,&#xD;
      however opioid agents have undesirable adverse effects such as respiratory depression,&#xD;
      sedation, constipation, nausea and vomiting etc. Ultrasound (US) -guided regional anesthesia&#xD;
      techniques may be preferred for pain management in patients underwent orthognathic surgery.&#xD;
      Regional anesthesia techniques may provide effective postoperative pain management as a part&#xD;
      of multimodal analgesia regimens. US-guided bilateral superficial cervical plexus block&#xD;
      (SCPB) have been performed for several head and neck surgeries and it provides effective pain&#xD;
      control. The cervical plexus presents between the longus capitis and middle scalene muscles,&#xD;
      under the prevertebral fascia. It is formed by the C2-4 cervical spinal nerves. There are the&#xD;
      end points of these nerves in the interfascial area under the SCM. Thus, the superfascial&#xD;
      branches of the cervical plexus may be blocked by injecting local anesthetic under the SCM.&#xD;
      Cervical plexus may be blocked with deep or superficial technique. The deep CPB is defined as&#xD;
      a paravertebral block. The deep branches may be targeted by this method. However it has some&#xD;
      major disadvantages such as intravascular injection, epidural or subarachnoid injection, and&#xD;
      phrenic nerve palsy, due to the deepness of the injection. Otherwise; SCPB is a superficial&#xD;
      method and it has lower complication rate compared to the deep CPB. In an anatomical study,&#xD;
      it has been reported that with SCPB there was spread of dye into the deep cervical fascia.&#xD;
      The authors emphasized that this mechanism may explain the efficacy of the SCPB. Thus, with&#xD;
      the SCPB both the superficial branches and the deep nerve roots may be blocked. Therefore,&#xD;
      SCPB may provide effective pain management following orthognathic surgery. In the literature,&#xD;
      there are no randomized clinical studies about pain management with US-guided SCPB after&#xD;
      orthognathic surgery, yet.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy of the US-guided SCPB for postoperative&#xD;
      analgesia management after orthognathic surgery. The primary aim is to evaluate postoperative&#xD;
      opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS),&#xD;
      adverse effects related with opioids (allergic reaction, nausea, vomiting) compared to no&#xD;
      intervention control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants&#xD;
  </why_stopped>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2022</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>
    <intervention_model_description>There are two models for this study. The first group is superficial cervical plexus block group. The second one is no intervention control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The anesthesiologist who performs postoperative pain evaluation will not know the group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours</time_frame>
    <description>The primary aim is to compare postoperative opioid consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores (Visual analogue scores-VAS)</measure>
    <time_frame>Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.</time_frame>
    <description>Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Maxillofacial Injuries</condition>
  <condition>Maxillofacial Trauma</condition>
  <condition>Maxillofacial Abnormalities</condition>
  <condition>Maxillofacial Dysostosis</condition>
  <arm_group>
    <arm_group_label>Group S = SCPB group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>US-guided SCPB will be performed at the end of the surgery before extubation, with patients in the supine position by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions using 10% povidone iodine, the high frequency linear probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath and a 22G, 50 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used.&#xD;
Sternocleidomastoid (SCM) muscle will be visualized. The 22 G needle will be inserted between the SCM and the prevertebral fascia by using in plane technique horizontally. The needle tip will be corrected with injecting 2 ml of normal saline. Then a 20 mL dose of 0.25% bupivacaine will be injected here. The same procedure will be performed for the opposite site (totally 40 mL dose of 0.25% bupivacaine).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C = Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group SCPB</intervention_name>
    <description>In group SCBP, SCBP block will be performed. Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.</description>
    <arm_group_label>Group S = SCPB group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
          -  Scheduled for orthognathic surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of bleeding diathesis,&#xD;
&#xD;
          -  receiving anticoagulant treatment,&#xD;
&#xD;
          -  known local anesthetics and opioid allergy,&#xD;
&#xD;
          -  infection of the skin at the site of the needle puncture,&#xD;
&#xD;
          -  pregnancy or lactation,&#xD;
&#xD;
          -  patients who do not accept the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bagcilar</state>
        <zip>34070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kim JS, Ko JS, Bang S, Kim H, Lee SY. Cervical plexus block. Korean J Anesthesiol. 2018 Aug;71(4):274-288. doi: 10.4097/kja.d.18.00143. Epub 2018 Jul 4.</citation>
    <PMID>29969890</PMID>
  </reference>
  <reference>
    <citation>Raschke GF, Meissner W, Peisker A, Djedovic G, Rieger U, Guentsch A, Dammeier MG, Schultze-Mosgau S. Bilateral sagittal split osteotomy-parameters and correlations of postoperative pain management. Clin Oral Investig. 2018 Jan;22(1):181-187. doi: 10.1007/s00784-017-2097-z. Epub 2017 Mar 14.</citation>
    <PMID>28293792</PMID>
  </reference>
  <reference>
    <citation>Pandit JJ, Dutta D, Morris JF. Spread of injectate with superficial cervical plexus block in humans: an anatomical study. Br J Anaesth. 2003 Nov;91(5):733-5. doi: 10.1093/bja/aeg250.</citation>
    <PMID>14570798</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medipol University</investigator_affiliation>
    <investigator_full_name>Bahadir Ciftci</investigator_full_name>
    <investigator_title>Primary researcher</investigator_title>
  </responsible_party>
  <keyword>Orthognathic surgery</keyword>
  <keyword>Postoperative pain management</keyword>
  <keyword>Superficial cervical plexus block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maxillofacial Abnormalities</mesh_term>
    <mesh_term>Dysostoses</mesh_term>
    <mesh_term>Maxillofacial Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not plan to share IPD</ipd_description>
  </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/NCT04442009
org study id: Medipol Hospital 15
nct id: NCT04442009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
US-guided superficial cervical plexus block (SCPB) may be used for several head and neck
      surgeries. Local anesthetic is injected under the sternocleidomastoid muscle for SCPB. It has
      lower complication rate compared to the deep cervical plexus block. Postoperative pain
      management is important in patients underwent orthognathic surgery. Effective pain treatment
      provides early mobilization, and shorter hospital stay.
Postoperative pain management is very important in patients underwent orthognathic surgery.
      Effective pain control provides early mobilization, shorter hospital stay and it increases
      the satisfaction of the patients. Opioid agents may provide effective pain management,
      however opioid agents have undesirable adverse effects such as respiratory depression,
      sedation, constipation, nausea and vomiting etc. Ultrasound (US) -guided regional anesthesia
      techniques may be preferred for pain management in patients underwent orthognathic surgery.
      Regional anesthesia techniques may provide effective postoperative pain management as a part
      of multimodal analgesia regimens. US-guided bilateral superficial cervical plexus block
      (SCPB) have been performed for several head and neck surgeries and it provides effective pain
      control. The cervical plexus presents between the longus capitis and middle scalene muscles,
      under the prevertebral fascia. It is formed by the C2-4 cervical spinal nerves. There are the
      end points of these nerves in the interfascial area under the SCM. Thus, the superfascial
      branches of the cervical plexus may be blocked by injecting local anesthetic under the SCM.
      Cervical plexus may be blocked with deep or superficial technique. The deep CPB is defined as
      a paravertebral block. The deep branches may be targeted by this method. However it has some
      major disadvantages such as intravascular injection, epidural or subarachnoid injection, and
      phrenic nerve palsy, due to the deepness of the injection. Otherwise; SCPB is a superficial
      method and it has lower complication rate compared to the deep CPB. In an anatomical study,
      it has been reported that with SCPB there was spread of dye into the deep cervical fascia.
      The authors emphasized that this mechanism may explain the efficacy of the SCPB. Thus, with
      the SCPB both the superficial branches and the deep nerve roots may be blocked. Therefore,
      SCPB may provide effective pain management following orthognathic surgery. In the literature,
      there are no randomized clinical studies about pain management with US-guided SCPB after
      orthognathic surgery, yet.

      The aim of this study is to evaluate the efficacy of the US-guided SCPB for postoperative
      analgesia management after orthognathic surgery. The primary aim is to evaluate postoperative
      opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS),
      adverse effects related with opioids (allergic reaction, nausea, vomiting) compared to no
      intervention control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two models for this study. The first group is superficial cervical plexus block group. The second one is no intervention control group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The anesthesiologist who performs postoperative pain evaluation will not know the group.
measure: Opioid consumption
time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, and 24 hours
description: The primary aim is to compare postoperative opioid consumption
measure: Pain scores (Visual analogue scores-VAS)
time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, and 24 hours.
description: Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded
arm group label: Group S = SCPB group
arm group type: Active Comparator
description: US-guided SCPB will be performed at the end of the surgery before extubation, with patients in the supine position by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions using 10% povidone iodine, the high frequency linear probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath and a 22G, 50 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used.
Sternocleidomastoid (SCM) muscle will be visualized. The 22 G needle will be inserted between the SCM and the prevertebral fascia by using in plane technique horizontally. The needle tip will be corrected with injecting 2 ml of normal saline. Then a 20 mL dose of 0.25% bupivacaine will be injected here. The same procedure will be performed for the opposite site (totally 40 mL dose of 0.25% bupivacaine).
arm group label: Group C = Control group
arm group type: No Intervention
description: Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
intervention type: Other
intervention name: Group SCPB
description: In group SCBP, SCBP block will be performed. Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
arm group label: Group S = SCPB group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Kim JS, Ko JS, Bang S, Kim H, Lee SY. Cervical plexus block. Korean J Anesthesiol. 2018 Aug;71(4):274-288. doi: 10.4097/kja.d.18.00143. Epub 2018 Jul 4.
PMID: 29969890
citation: Raschke GF, Meissner W, Peisker A, Djedovic G, Rieger U, Guentsch A, Dammeier MG, Schultze-Mosgau S. Bilateral sagittal split osteotomy-parameters and correlations of postoperative pain management. Clin Oral Investig. 2018 Jan;22(1):181-187. doi: 10.1007/s00784-017-2097-z. Epub 2017 Mar 14.
PMID: 28293792
citation: Pandit JJ, Dutta D, Morris JF. Spread of injectate with superficial cervical plexus block in humans: an anatomical study. Br J Anaesth. 2003 Nov;91(5):733-5. doi: 10.1093/bja/aeg250.
PMID: 14570798
responsible party type: Principal Investigator
investigator affiliation: Medipol University
investigator full name: Bahadir Ciftci
investigator title: Primary researcher
mesh term: Maxillofacial Abnormalities
mesh term: Dysostoses
mesh term: Maxillofacial Injuries
sharing ipd: No
ipd description: We will not plan to share IPD