<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/NCT04435236</url>
  </required_header>
  <id_info>
    <org_study_id>B.30.2.ATA.0.01.00/142</org_study_id>
    <nct_id>NCT04435236</nct_id>
  </id_info>
  <brief_title>Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery</brief_title>
  <acronym>cESPINas</acronym>
  <official_title>Cervical Erector Spinae Plane Block Versus Interscalene Plexus Block for Pain Relief After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk 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>
      Severe pain after arthroscopic surgery is a common experience for the patients . Different&#xD;
      regional anesthetic technique has been applicated for postoperative pain relief . The main&#xD;
      goal of regional anesthesia regarding postoperative pain relief is to reduce opioid&#xD;
      requirements. The most commonly used approach is Interscalene brachial plexus block (ISB),&#xD;
      since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block&#xD;
      (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery.&#xD;
      Recently, a novel description of a T2-3 erector spinae plane (ESP) as an alternative to a BP&#xD;
      block for an upper extremity surgical procedure. Following these studies, direct cervical ESP&#xD;
      block has been recently performed successfully as both clinical and cadaveric study. The&#xD;
      investigators hypothesized that cervical ESP block is as effective as (non-inferior)&#xD;
      interscalene brachial plexus block in terms of postoperative analgesia of shoulder surgery.&#xD;
      To evaluate the effectiveness of the cervical ESP block, the investigators have designed a&#xD;
      randomized study. Primary aim is to evaluate the postoperative opioid consumption. Secondary&#xD;
      aim is to evaluate postoperative pain scores by Numeric Rating Scale (0 to 10 point scale).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has been designed as a prospective, randomized and single-blind trial. Local&#xD;
      ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After&#xD;
      obtaining the patients' written informed consents, we will include a total number of 94&#xD;
      patients (47 patients for each group). The inclusion criteria of the study was considered as&#xD;
      age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for&#xD;
      regional anesthesia, and unilateral shoulder surgery. The patients who have clotting&#xD;
      disorder, contra-indication for regional anesthesia, infection on the injection site, chronic&#xD;
      opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary&#xD;
      disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A&#xD;
      computer-generated randomization program will be used to allocate the patient into two&#xD;
      groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and&#xD;
      cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes&#xD;
      will be blinded to the study groups of the patients. Both ISB block and cervical ESP block&#xD;
      will be performed under ultrasound guidance in the block room preoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2021</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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 (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain scores</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Cervical ESP block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cervical ESP block will be performed as described by Elsharkawy at al. (7).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ISB Block group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cervical ESP block</intervention_name>
    <description>Cervical ESP block will be performed as described by Elsharkawy at al. (7). ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles</description>
    <arm_group_label>Cervical ESP block group</arm_group_label>
    <arm_group_label>ISB Block group</arm_group_label>
    <other_name>ISB Block</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-80&#xD;
&#xD;
          2. ASA I-III&#xD;
&#xD;
          3. Eligible for regional anesthesia&#xD;
&#xD;
          4. Unilateral shoulder surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patients who have clotting disorder&#xD;
&#xD;
          2. Contra-endication for regional anesthesia&#xD;
&#xD;
          3. Infection on the injection site&#xD;
&#xD;
          4. Chronic opioid usage&#xD;
&#xD;
          5. Previous same side shoulder surgery&#xD;
&#xD;
          6. Severe COPD&#xD;
&#xD;
          7. Diaphragmatic paralysis&#xD;
&#xD;
          8. BMI 35 or over&#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>İlker İnce, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ataturk University Anesthesiology Clinical Research Office</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>İlker İnce, MD</last_name>
    <phone>+905052949840</phone>
    <email>ilkerince1983@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mehmet Aksoy, MD</last_name>
    <email>drmaksoy@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.</citation>
    <PMID>20565394</PMID>
  </reference>
  <reference>
    <citation>Demir U, Ince I, Aksoy M, Dostbil A, Ari MA, Sulak MM, Kose M, Tanios M, Ozmen O. The Effect of Pre-emptive Dexketoprofen Administration on Postoperative Pain Management in Patients with Ultrasound Guided Interscalene Block in Arthroscopic Shoulder Surgery. J Invest Surg. 2021 Jan;34(1):82-88. doi: 10.1080/08941939.2019.1576809. Epub 2019 Apr 9.</citation>
    <PMID>30966835</PMID>
  </reference>
  <reference>
    <citation>Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.</citation>
    <PMID>9174311</PMID>
  </reference>
  <reference>
    <citation>Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132. Erratum In: Anesthesiology. 2020 Apr 3;:null.</citation>
    <PMID>32044802</PMID>
  </reference>
  <reference>
    <citation>Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.</citation>
    <PMID>29868941</PMID>
  </reference>
  <reference>
    <citation>Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.</citation>
    <PMID>31161549</PMID>
  </reference>
  <reference>
    <citation>Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.</citation>
    <PMID>32321860</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 20, 2021</last_update_submitted>
  <last_update_submitted_qc>June 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>Ilker Ince</investigator_full_name>
    <investigator_title>Associated Prof. Dr. MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Undecided</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/NCT04435236
org study id: B.30.2.ATA.0.01.00/142
nct id: NCT04435236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe pain after arthroscopic surgery is a common experience for the patients . Different
      regional anesthetic technique has been applicated for postoperative pain relief . The main
      goal of regional anesthesia regarding postoperative pain relief is to reduce opioid
      requirements. The most commonly used approach is Interscalene brachial plexus block (ISB),
      since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block
      (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery.
      Recently, a novel description of a T2-3 erector spinae plane (ESP) as an alternative to a BP
      block for an upper extremity surgical procedure. Following these studies, direct cervical ESP
      block has been recently performed successfully as both clinical and cadaveric study. The
      investigators hypothesized that cervical ESP block is as effective as (non-inferior)
      interscalene brachial plexus block in terms of postoperative analgesia of shoulder surgery.
      To evaluate the effectiveness of the cervical ESP block, the investigators have designed a
      randomized study. Primary aim is to evaluate the postoperative opioid consumption. Secondary
      aim is to evaluate postoperative pain scores by Numeric Rating Scale (0 to 10 point scale).
This study has been designed as a prospective, randomized and single-blind trial. Local
      ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After
      obtaining the patients' written informed consents, we will include a total number of 94
      patients (47 patients for each group). The inclusion criteria of the study was considered as
      age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for
      regional anesthesia, and unilateral shoulder surgery. The patients who have clotting
      disorder, contra-indication for regional anesthesia, infection on the injection site, chronic
      opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary
      disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A
      computer-generated randomization program will be used to allocate the patient into two
      groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and
      cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes
      will be blinded to the study groups of the patients. Both ISB block and cervical ESP block
      will be performed under ultrasound guidance in the block room preoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Opioid consumption
time frame: 24 hours postoperatively
description: Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients
measure: Postoperative pain scores
time frame: 24 hours postoperatively
description: A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.
arm group label: Cervical ESP block group
arm group type: Active Comparator
description: Cervical ESP block will be performed as described by Elsharkawy at al. (7).
arm group label: ISB Block group
arm group type: Sham Comparator
description: ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
intervention type: Procedure
intervention name: Cervical ESP block
description: Cervical ESP block will be performed as described by Elsharkawy at al. (7). ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
arm group label: Cervical ESP block group
arm group label: ISB Block group
other name: ISB Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: İlker İnce, MD
role: Principal Investigator
affiliation: Ataturk University Anesthesiology Clinical Research Office
last name: İlker İnce, MD
phone: +905052949840
email: ilkerince1983@yahoo.com
last name: Mehmet Aksoy, MD
email: drmaksoy@hotmail.com
citation: Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PMID: 20565394
citation: Demir U, Ince I, Aksoy M, Dostbil A, Ari MA, Sulak MM, Kose M, Tanios M, Ozmen O. The Effect of Pre-emptive Dexketoprofen Administration on Postoperative Pain Management in Patients with Ultrasound Guided Interscalene Block in Arthroscopic Shoulder Surgery. J Invest Surg. 2021 Jan;34(1):82-88. doi: 10.1080/08941939.2019.1576809. Epub 2019 Apr 9.
PMID: 30966835
citation: Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.
PMID: 9174311
citation: Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132. Erratum In: Anesthesiology. 2020 Apr 3;:null.
PMID: 32044802
citation: Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
PMID: 29868941
citation: Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
PMID: 31161549
citation: Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
PMID: 32321860
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: Ilker Ince
investigator title: Associated Prof. Dr. MD
mesh term: Acute Pain
sharing ipd: No
ipd description: Undecided