<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/NCT03815799</url>
  </required_header>
  <id_info>
    <org_study_id>ESP-RF</org_study_id>
    <nct_id>NCT03815799</nct_id>
  </id_info>
  <brief_title>The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy</brief_title>
  <official_title>The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konya Meram State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Meram State Hospital</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>
      The aim of this study is to assess the effect of ultrasound guided erector spinae block in&#xD;
      control of the postoperative pain and the respiratory functions after laparoscopic&#xD;
      cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scoring of postoperative pain</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic consumption</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Total opioid consumption after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometric Parameters of Respiratory Functions</measure>
    <time_frame>Preoperative (before the surgery) and at postoperative 24th hour</time_frame>
    <description>Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse events</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>Postoperative nausea and vomiting incidents at PACU and and at ward.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Laparoscopic Cholecystectomy</condition>
  <condition>Postoperative Pain</condition>
  <condition>Respiratory Function</condition>
  <arm_group>
    <arm_group_label>Erector Spinae Plane Block Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure:&#xD;
In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Routine standard perioperative and postoperative analgesic protocol will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Erector Spinae Block</intervention_name>
    <description>A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).</description>
    <arm_group_label>Erector Spinae Plane Block Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled&#xD;
        for elective laparoscopic cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusal&#xD;
&#xD;
          -  Contraindications for regional anesthesia&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Chronic opioid intake&#xD;
&#xD;
          -  Patient with psychiatric disorders&#xD;
&#xD;
          -  Use of pain killers within the 24 h before the operation&#xD;
&#xD;
          -  Respiratory tract infection within the last 2 weeks&#xD;
&#xD;
          -  Smoker or history of smoking&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Respiratory and allergic diseases&#xD;
&#xD;
          -  Cardiac disease associated with dyspnea&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Konya Education and Training Hospital</name>
      <address>
        <city>Konya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.</citation>
    <PMID>29913392</PMID>
  </reference>
  <reference>
    <citation>Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.</citation>
    <PMID>25948166</PMID>
  </reference>
  <reference>
    <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
    <PMID>27501016</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation>
    <investigator_full_name>Asst. Prof. Munıse Yıldız M.D.</investigator_full_name>
    <investigator_title>Ass.Prof.</investigator_title>
  </responsible_party>
  <keyword>Erector Spinae Block</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Respiratory Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03815799
org study id: ESP-RF
nct id: NCT03815799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the effect of ultrasound guided erector spinae block in
      control of the postoperative pain and the respiratory functions after laparoscopic
      cholecystectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Scoring of postoperative pain
time frame: Postoperative 24 hour
description: The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
measure: Analgesic consumption
time frame: Postoperative 24 hour
description: Total opioid consumption after the operation
measure: Spirometric Parameters of Respiratory Functions
time frame: Preoperative (before the surgery) and at postoperative 24th hour
description: Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)
measure: Number of Adverse events
time frame: Postoperative 24 hour
description: Postoperative nausea and vomiting incidents at PACU and and at ward.
arm group label: Erector Spinae Plane Block Group
arm group type: Experimental
description: Procedure:
In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.
arm group label: Control
arm group type: Sham Comparator
description: Routine standard perioperative and postoperative analgesic protocol will be given.
intervention type: Procedure
intervention name: Bilateral Erector Spinae Block
description: A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).
arm group label: Erector Spinae Plane Block Group
intervention type: Other
intervention name: Control
description: Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
PMID: 29913392
citation: Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
PMID: 25948166
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PMID: 27501016
responsible party type: Principal Investigator
investigator affiliation: Konya Meram State Hospital
investigator full name: Asst. Prof. Munıse Yıldız M.D.
investigator title: Ass.Prof.
mesh term: Pain, Postoperative
sharing ipd: No