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/NCT05996133</url>
    </required_header>
    <id_info>
      <org_study_id>HHC-2023-0156</org_study_id>
      <nct_id>NCT05996133</nct_id>
    </id_info>
    <brief_title>Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery</brief_title>
    <acronym>MCP</acronym>
    <official_title>MCP Study, A Double-Blinded, Randomized Controlled Trial To Compare Multifidus Cervicis Plane Block (MCP) Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery (CSFS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hartford Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hartford Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized, double-blinded, clinical trial is to assess the benefit of&#xD;
        administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of&#xD;
        postoperative pain control in patients undergoing posterior cervical spine fusion surgery.&#xD;
        The main question it aims to answer is if the MCP block group will have reduced maximum pain&#xD;
        scores during the first 24 postoperative hours compared to the sham block group.&#xD;
  &#xD;
        Participants will receive preoperative bilateral MCP blocks on the back of their neck using&#xD;
        the standard of care local anesthetic solution that consists of 30 mLs 0.25% Bupivacaine +&#xD;
        0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 mL Epinephrine (MCP block group).&#xD;
        Researchers will compare the MCP block to the preoperative sham block which consists of&#xD;
        injecting 3 mL of normal saline into the same area (Sham block group) to compare the&#xD;
        postoperative pain scores between the groups as a main objective. The secondary objectives&#xD;
        are:&#xD;
  &#xD;
          -  Postoperative opioid consumption during hospitalization and at 2 weeks after discharge.&#xD;
  &#xD;
          -  The amount and type of non-opioid analgesics used during hospitalization.&#xD;
  &#xD;
          -  The occurrence of postoperative nausea and vomiting (PONV) and the use of antiemetics.&#xD;
  &#xD;
          -  Hospital and Post Anesthesia Care Unit length of stay (LOS).&#xD;
  &#xD;
          -  Monitor the safety of the study interventions during hospitalization and readmissions&#xD;
             within 30 days of discharge.&#xD;
  &#xD;
          -  Patient satisfaction with pain management and overall satisfaction with the surgery&#xD;
             experience.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Single-center, prospective, double-blinded, randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>This is a double-blinded study, patients, research coordinators who collect data, spine surgeons, and other health care providers will all be blinded to the study group assignments to minimize bias and maximize the validity of study results. The block-performing anesthesiologists/investigators, the block nurse, and the senior scientist will not be blinded to the study group assignments.&#xD;
  Patients will not be unblinded after they complete the study or during the study unless a participant experiences a serious adverse event that is unexpected and related to the study intervention (MCP or sham block) and the course of treatment needs to be adjusted. Unblinding in this situation will be the decision of the principal investigator (PI). The PI will contact the Senior Scientist to get the patient's group assignment, and the PI will then unblind the patient (i.e., tell the patient about the assigned group), and take any additional necessary course of treatment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The maximum postoperative pain score</measure>
      <time_frame>Up to 24 hours after surgery</time_frame>
      <description>The maximum pain score for the past 24 postoperative hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants using the validated tool; Brief Pain Inventory-Short Form.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The maximum, average, minimum, and current pain scores</measure>
      <time_frame>0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.</time_frame>
      <description>The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain, reported by participants daily and up to 72 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total opioid consumption</measure>
      <time_frame>at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.</time_frame>
      <description>The total intraoperative and postoperative opioid consumption will be measured in morphine MilliEquivalent (MME) during hospitalization on the 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge via a phone call using a question asking if the patient is still using opioids (yes/no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non- opioid analgesics use</measure>
      <time_frame>Up to 72 hours postoperative</time_frame>
      <description>The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea/vomiting scores</measure>
      <time_frame>Daily at 24th, 48th, and 72th postoperative hours</time_frame>
      <description>Postoperative nausea/vomiting scores will be collected using the Simplified Postoperative Nausea and Vomiting Impact Scale, a validated measure that consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital and Post Anesthesia Care Unit length of stay</measure>
      <time_frame>Up to 72 postoperative hours</time_frame>
      <description>Hospital and PACU length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The occurrence of block complications</measure>
      <time_frame>Up to 72 postoperative hours</time_frame>
      <description>The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant satisfaction with the pain management service and the overall surgery experience</measure>
      <time_frame>at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call</time_frame>
      <description>Using the Customer Satisfaction Score (CSAT) tool, prior to discharge and at 2 weeks (+/- 7 days) after discharge via a phone call by the ARC. By asking participants to rate their satisfaction with pain management service and the overall surgery experience on a five-point scale: 1- very unsatisfied; 2- Unsatisfied; 3- Neutral; 4- Satisfied; and 5- Very satisfied. The metric will be looking specifically at the percentage of happy patients. The CSAT percentage score is calculated by looking at the 4 to 5 ratings. The formula is: (The total Number of 4 and 5 responses) ÷ (Number of total responses) x 100 = % of satisfied patients, a score of 80% will be considered 'good'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antiemetics used</measure>
      <time_frame>up to 72 postoperative hours</time_frame>
      <description>The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">38</enrollment>
    <condition>Cervical Spine Fusion</condition>
    <arm_group>
      <arm_group_label>MCP Block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Bilateral Multifidus Cervicis plane block using 30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham Block</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain</intervention_name>
      <description>30 mL of 0.25% bupivacaine</description>
      <arm_group_label>MCP Block</arm_group_label>
      <other_name>Marcaine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>0.5 mL (5 mg) preservative-free dexamethasone</description>
      <arm_group_label>MCP Block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Epinephrine</intervention_name>
      <description>0.1 mL epinephrine 1:400,000.</description>
      <arm_group_label>MCP Block</arm_group_label>
      <other_name>Adrenaline</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal saline</intervention_name>
      <description>3 mL normal saline</description>
      <arm_group_label>Sham Block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients 40-80 years old, males and females, of any race and any ethnic group.&#xD;
  &#xD;
            2. Patients are scheduled for elective primary posterior cervical spine fusion surgery&#xD;
               (CSFS) to be performed by one of the spine surgeons in the study.&#xD;
  &#xD;
            3. Ability to speak and read English&#xD;
  &#xD;
            4. Patients with American Society of Anesthesiology (ASA) physical status score I- IV&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Emergency posterior CSFS.&#xD;
  &#xD;
            2. Revision surgery or history of previous cervical spine surgery&#xD;
  &#xD;
            3. History of allergy to local anesthetics or steroids.&#xD;
  &#xD;
            4. Patients who are coagulopathic at the time of surgery&#xD;
  &#xD;
            5. Patients with contraindications to MCP blocks, including but not limited to anatomical&#xD;
               abnormality or previous surgical intervention that limits or prevents receiving the&#xD;
               blocks&#xD;
  &#xD;
            6. Infection at the site of the block.&#xD;
  &#xD;
            7. Weight &lt; 40 kg to avoid local anesthetic toxicity.&#xD;
  &#xD;
            8. Patients on chronic or continuous opioid use of &gt; 50 MME (morphine milli-equivalent)&#xD;
               per day for at least 30 days within 90 days prior to surgery.&#xD;
  &#xD;
            9. Patients with a history of chronic inflammatory conditions such as multiple sclerosis&#xD;
  &#xD;
           10. Refusal to participate or lack of providing the study consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pranjali Kainkaryam, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hartford Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aseel Walker, MD</last_name>
      <phone>(860) 972-1778</phone>
      <email>aseel.walker@hhchealth.org</email>
    </overall_contact>
    <reference>
      <citation>Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.</citation>
      <PMID>28403427</PMID>
    </reference>
    <reference>
      <citation>Tseng V, Cole C, Schmidt MH, Abramowicz AE, Xu JL. Analgesic efficacy of paraspinal interfascial plane blocks performed with the use of neurophysiology monitoring for posterior cervical laminectomy surgery: a case series. J Spine Surg. 2021 Mar;7(1):109-113. doi: 10.21037/jss-20-644.</citation>
      <PMID>33834133</PMID>
    </reference>
    <reference>
      <citation>Youssef JA, Heiner AD, Montgomery JR, Tender GC, Lorio MP, Morreale JM, Phillips FM. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis. Spine J. 2019 Oct;19(10):1714-1729. doi: 10.1016/j.spinee.2019.04.019. Epub 2019 May 7.</citation>
      <PMID>31075361</PMID>
    </reference>
    <reference>
      <citation>Raja A, Hoang S, Patel P, Mesfin FB. Spinal Stenosis. 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/</citation>
      <PMID>28723018</PMID>
    </reference>
    <reference>
      <citation>Ohgoshi Y, Kurahashi K. Cervical interfascial plane (CIP) block and multifidus cervicis plane (MCP) block: Similarities and tips. J Clin Anesth. 2017 Sep;41:55. doi: 10.1016/j.jclinane.2017.06.014. Epub 2017 Jun 27. No abstract available.</citation>
      <PMID>28802607</PMID>
    </reference>
    <reference>
      <citation>Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.</citation>
      <PMID>29433034</PMID>
    </reference>
    <reference>
      <citation>Mohamed, Z.E., Zarad, C.A., Flifel, M.E. et al. The efficacy of ultrasound-guided multifidus cervicis plane block versus greater occipital nerve block for cervicogenic headache. Egypt J Neurol Psychiatry Neurosurg 57, 11 (2021). https://doi.org/10.1186/s41983-020-00262-4</citation>
    </reference>
    <reference>
      <citation>Adamczyk K, Koszela K, Zaczynski A, Niedzwiecki M, Brzozowska-Mankowska S, Gasik R. Ultrasound-Guided Blocks for Spine Surgery: Part 1-Cervix. Int J Environ Res Public Health. 2023 Jan 23;20(3):2098. doi: 10.3390/ijerph20032098.</citation>
      <PMID>36767465</PMID>
    </reference>
    <results_reference>
      <citation>Ahiskalioglu A, Yayik AM, Doymus O, Selvitopi K, Ahiskalioglu EO, Calikoglu C, Alici HA, Karaca O. Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for postoperative analgesia after spinal surgery: a randomized-controlled trial. Can J Anaesth. 2018 May;65(5):603-604. doi: 10.1007/s12630-018-1051-0. Epub 2018 Jan 9. No abstract available.</citation>
      <PMID>29318534</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hartford Hospital</investigator_affiliation>
      <investigator_full_name>Pranjali P Kainkaryam, MD</investigator_full_name>
      <investigator_title>Director of Regional Anesthesia &amp; Acute Pain Management</investigator_title>
    </responsible_party>
    <keyword>Posterior cervical spine fusion surgery</keyword>
    <keyword>Multifidus Cervicis Plane Block</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Epinephrine</mesh_term>
      <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/NCT05996133
  org study id: HHC-2023-0156
  nct id: NCT05996133
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this randomized, double-blinded, clinical trial is to assess the benefit of
        administering a Multifidus Cervicis Plane (MCP) block compared to a sham block as a method of
        postoperative pain control in patients undergoing posterior cervical spine fusion surgery.
        The main question it aims to answer is if the MCP block group will have reduced maximum pain
        scores during the first 24 postoperative hours compared to the sham block group.
  
        Participants will receive preoperative bilateral MCP blocks on the back of their neck using
        the standard of care local anesthetic solution that consists of 30 mLs 0.25% Bupivacaine +
        0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 mL Epinephrine (MCP block group).
        Researchers will compare the MCP block to the preoperative sham block which consists of
        injecting 3 mL of normal saline into the same area (Sham block group) to compare the
        postoperative pain scores between the groups as a main objective. The secondary objectives
        are:
  
          -  Postoperative opioid consumption during hospitalization and at 2 weeks after discharge.
  
          -  The amount and type of non-opioid analgesics used during hospitalization.
  
          -  The occurrence of postoperative nausea and vomiting (PONV) and the use of antiemetics.
  
          -  Hospital and Post Anesthesia Care Unit length of stay (LOS).
  
          -  Monitor the safety of the study interventions during hospitalization and readmissions
             within 30 days of discharge.
  
          -  Patient satisfaction with pain management and overall satisfaction with the surgery
             experience.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Single-center, prospective, double-blinded, randomized controlled trial
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  masking description: This is a double-blinded study, patients, research coordinators who collect data, spine surgeons, and other health care providers will all be blinded to the study group assignments to minimize bias and maximize the validity of study results. The block-performing anesthesiologists/investigators, the block nurse, and the senior scientist will not be blinded to the study group assignments.
  Patients will not be unblinded after they complete the study or during the study unless a participant experiences a serious adverse event that is unexpected and related to the study intervention (MCP or sham block) and the course of treatment needs to be adjusted. Unblinding in this situation will be the decision of the principal investigator (PI). The PI will contact the Senior Scientist to get the patient's group assignment, and the PI will then unblind the patient (i.e., tell the patient about the assigned group), and take any additional necessary course of treatment.
  measure: The maximum postoperative pain score
  time frame: Up to 24 hours after surgery
  description: The maximum pain score for the past 24 postoperative hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants using the validated tool; Brief Pain Inventory-Short Form.
  measure: The maximum, average, minimum, and current pain scores
  time frame: 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.
  description: The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain, reported by participants daily and up to 72 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
  measure: Total opioid consumption
  time frame: at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.
  description: The total intraoperative and postoperative opioid consumption will be measured in morphine MilliEquivalent (MME) during hospitalization on the 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge via a phone call using a question asking if the patient is still using opioids (yes/no)
  measure: Non- opioid analgesics use
  time frame: Up to 72 hours postoperative
  description: The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively.
  measure: Postoperative nausea/vomiting scores
  time frame: Daily at 24th, 48th, and 72th postoperative hours
  description: Postoperative nausea/vomiting scores will be collected using the Simplified Postoperative Nausea and Vomiting Impact Scale, a validated measure that consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting.
  measure: Hospital and Post Anesthesia Care Unit length of stay
  time frame: Up to 72 postoperative hours
  description: Hospital and PACU length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records.
  measure: The occurrence of block complications
  time frame: Up to 72 postoperative hours
  description: The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital.
  measure: Participant satisfaction with the pain management service and the overall surgery experience
  time frame: at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call
  description: Using the Customer Satisfaction Score (CSAT) tool, prior to discharge and at 2 weeks (+/- 7 days) after discharge via a phone call by the ARC. By asking participants to rate their satisfaction with pain management service and the overall surgery experience on a five-point scale: 1- very unsatisfied; 2- Unsatisfied; 3- Neutral; 4- Satisfied; and 5- Very satisfied. The metric will be looking specifically at the percentage of happy patients. The CSAT percentage score is calculated by looking at the 4 to 5 ratings. The formula is: (The total Number of 4 and 5 responses) ÷ (Number of total responses) x 100 = % of satisfied patients, a score of 80% will be considered 'good'.
  measure: Antiemetics used
  time frame: up to 72 postoperative hours
  description: The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours.
  arm group label: MCP Block
  arm group type: Experimental
  description: Bilateral Multifidus Cervicis plane block using 30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.
  arm group label: Sham Block
  arm group type: Sham Comparator
  description: Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
  intervention type: Drug
  intervention name: Bupivacain
  description: 30 mL of 0.25% bupivacaine
  arm group label: MCP Block
  other name: Marcaine
  intervention type: Drug
  intervention name: Dexamethasone
  description: 0.5 mL (5 mg) preservative-free dexamethasone
  arm group label: MCP Block
  intervention type: Drug
  intervention name: Epinephrine
  description: 0.1 mL epinephrine 1:400,000.
  arm group label: MCP Block
  other name: Adrenaline
  intervention type: Drug
  intervention name: Normal saline
  description: 3 mL normal saline
  arm group label: Sham Block
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Pranjali Kainkaryam, MD
  role: Principal Investigator
  affiliation: Hartford Hospital
  last name: Aseel Walker, MD
  phone: (860) 972-1778
  email: aseel.walker@hhchealth.org
  citation: Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
  PMID: 28403427
  citation: Tseng V, Cole C, Schmidt MH, Abramowicz AE, Xu JL. Analgesic efficacy of paraspinal interfascial plane blocks performed with the use of neurophysiology monitoring for posterior cervical laminectomy surgery: a case series. J Spine Surg. 2021 Mar;7(1):109-113. doi: 10.21037/jss-20-644.
  PMID: 33834133
  citation: Youssef JA, Heiner AD, Montgomery JR, Tender GC, Lorio MP, Morreale JM, Phillips FM. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis. Spine J. 2019 Oct;19(10):1714-1729. doi: 10.1016/j.spinee.2019.04.019. Epub 2019 May 7.
  PMID: 31075361
  citation: Raja A, Hoang S, Patel P, Mesfin FB. Spinal Stenosis. 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/
  PMID: 28723018
  citation: Ohgoshi Y, Kurahashi K. Cervical interfascial plane (CIP) block and multifidus cervicis plane (MCP) block: Similarities and tips. J Clin Anesth. 2017 Sep;41:55. doi: 10.1016/j.jclinane.2017.06.014. Epub 2017 Jun 27. No abstract available.
  PMID: 28802607
  citation: Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.
  PMID: 29433034
  citation: Mohamed, Z.E., Zarad, C.A., Flifel, M.E. et al. The efficacy of ultrasound-guided multifidus cervicis plane block versus greater occipital nerve block for cervicogenic headache. Egypt J Neurol Psychiatry Neurosurg 57, 11 (2021). https://doi.org/10.1186/s41983-020-00262-4
  citation: Adamczyk K, Koszela K, Zaczynski A, Niedzwiecki M, Brzozowska-Mankowska S, Gasik R. Ultrasound-Guided Blocks for Spine Surgery: Part 1-Cervix. Int J Environ Res Public Health. 2023 Jan 23;20(3):2098. doi: 10.3390/ijerph20032098.
  PMID: 36767465
  citation: Ahiskalioglu A, Yayik AM, Doymus O, Selvitopi K, Ahiskalioglu EO, Calikoglu C, Alici HA, Karaca O. Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for postoperative analgesia after spinal surgery: a randomized-controlled trial. Can J Anaesth. 2018 May;65(5):603-604. doi: 10.1007/s12630-018-1051-0. Epub 2018 Jan 9. No abstract available.
  PMID: 29318534
  responsible party type: Principal Investigator
  investigator affiliation: Hartford Hospital
  investigator full name: Pranjali P Kainkaryam, MD
  investigator title: Director of Regional Anesthesia & Acute Pain Management
  mesh term: Dexamethasone
  mesh term: Epinephrine
  mesh term: Bupivacaine
  sharing ipd: No