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/NCT05979597</url>
    </required_header>
    <id_info>
      <org_study_id>SFIB-TEZ</org_study_id>
      <nct_id>NCT05979597</nct_id>
    </id_info>
    <brief_title>The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in SFIB</brief_title>
    <official_title>The Effect of Adjuvant Dexamethasone on Postoperative Pain, Analgesic Consumption and Block Properties in Suprainguinal Fascia Iliaca Block (SFIB) in Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsun Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsun Education and Research 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 investigators aimed to demonstrate that dexamethasone added as an adjuvant to local&#xD;
        anaesthetic agent in suprainguinal fascia iliaca block for effective postoperative analgesia&#xD;
        after knee arthroplasty would prolong the duration of sensory block and reduce postoperative&#xD;
        pain intensity and analgesic consumption.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Total knee arthroplasty is one of the major orthopedic surgeries that cause severe&#xD;
        postoperative pain. A successful post-operative outcome is possible with strong and effective&#xD;
        pain control followed by early mobilization and a good functional recovery. Suprainguinal&#xD;
        fascia iliaca plan block (SFIB) has been shown to be an effective postoperative method in&#xD;
        multimodal analgesia regime in lower extremity surgery. It has been reported in the&#xD;
        literature that dexamethasone added to local anaesthetics in peripheral nerve blocks prolongs&#xD;
        the duration of sensory block, improves the quality of analgesia, reduces postoperative pain&#xD;
        intensity and opioid consumption.&#xD;
  &#xD;
        In this study, the investigators aimed to demonstrate that dexamethasone added as an adjuvant&#xD;
        to local anaesthetic agent in SFIB for effective postoperative analgesia after knee&#xD;
        arthroplasty would prolong the duration of sensory block and reduce postoperative pain&#xD;
        intensity and analgesic consumption.&#xD;
  &#xD;
        An identification number will be randomly assigned to each participants, whose written&#xD;
        consent was obtained before the surgery, when they are admitted to the postoperative recovery&#xD;
        room. In the postoperative period, participants will be followed up with these numbers. Which&#xD;
        group the participants will be included in will be determined by the closed envelope method.&#xD;
  &#xD;
        Participants undergoing unilateral knee arthroplasty will be included in the study. Following&#xD;
        the end of surgery, the participants will be divided into two groups in the recovery room and&#xD;
        SFIB will be applied to both groups. Participants in group SFIB will receive 0.25%&#xD;
        bupivacaine as local anaesthetic. Participants in group SFIB+dexamethasone will receive 0.25%&#xD;
        bupivacaine as local anaesthetic and 8 mg dexamethasone as adjuvant.&#xD;
  &#xD;
        The participant with the block will be followed in the recovery room and if the block is&#xD;
        successful, morphine patient controlled analgesia (PCA) treatment will be started and the&#xD;
        participant will be taken to the ward. A standard analgesia regimen (1 g iv paracetamol every&#xD;
        8 hours, 50 mg iv dexketoprofen every 12 hours) was used in all participants.&#xD;
  &#xD;
        Evaluation of postoperative pain will be done with numerical rating scale (NRS). Pain levels&#xD;
        will be questioned in two different ways as rest and passive moving.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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, Investigator)</masking>
      <masking_description>The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative opioid consumption</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>First 24 hours total morphine consumption with patient controlled analgesia</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Numerical Rating Scale</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Timed up and go test (TUG)</measure>
      <time_frame>at 24th hour</time_frame>
      <description>TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quadriceps muscle strength</measure>
      <time_frame>at 24th hour</time_frame>
      <description>will be evaluated in a scale between 1-5 (1:lowest; 5:normal)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Regional Anesthesia</condition>
    <arm_group>
      <arm_group_label>Group SFIB (Suprainguinal fascia iliaca block)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic+dexamethasone into this space.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Suprainguinal fascia iliaca block</intervention_name>
      <description>After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.</description>
      <arm_group_label>Group SFIB (Suprainguinal fascia iliaca block)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Suprainguinal fascia iliaca block+dexamethasone</intervention_name>
      <description>After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic+dexamethasone injection will be made between the fascia and the muscle.</description>
      <arm_group_label>Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having undergone unilateral knee replacement surgery under elective conditions,&#xD;
  &#xD;
            -  Age range of 18-75 years,&#xD;
  &#xD;
            -  American Society of Anesthesiologist's physiologic state I-III patients,&#xD;
  &#xD;
            -  written consent who agreed to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI&gt;35&#xD;
  &#xD;
            -  who do not want to be included in the study by not signing the voluntary consent form,&#xD;
  &#xD;
            -  Local infection, hematoma, hernia, neoplasm etc. in the area to be blocked. found,&#xD;
  &#xD;
            -  Coagulopathy, hepatic or renal failure,&#xD;
  &#xD;
            -  Allergic to a local anesthetic agent or one of the drugs used in the study,&#xD;
  &#xD;
            -  Having a history of chronic opioid and corticosteroid use,&#xD;
  &#xD;
            -  who cannot use the patient-controlled analgesia system and have a psychiatric disease,&#xD;
  &#xD;
            -  with operative time less than 20 minutes and more than 120 minutes for better&#xD;
               standardization of studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mustafa Süren, Professor</last_name>
      <role>Study Chair</role>
      <affiliation>Samsun Research and Education Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hale Kefeli Celik, MD</last_name>
      <phone>+905057242409</phone>
      <email>ck_hale@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elif Colak, Professor</last_name>
      <phone>+905323754163</phone>
      <email>elifmangancolak@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Samsun Research and Education Hospital</name>
        <address>
          <city>Samsun</city>
          <zip>55090</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.</citation>
      <PMID>28861197</PMID>
    </results_reference>
    <results_reference>
      <citation>Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.</citation>
      <PMID>31272654</PMID>
    </results_reference>
    <results_reference>
      <citation>Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.</citation>
      <PMID>30250982</PMID>
    </results_reference>
    <results_reference>
      <citation>Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.</citation>
      <PMID>29121400</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsun Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Hale Kefeli Celik</investigator_full_name>
      <investigator_title>Anesthesiologist, Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>regional anesthesia</keyword>
    <keyword>suprainguinal fascia iliaca block</keyword>
    <keyword>dexamethasone</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Researched data and statistical analyzes will be available from the journal in which the clinical study was published</ipd_description>
    </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/NCT05979597
  org study id: SFIB-TEZ
  nct id: NCT05979597
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators aimed to demonstrate that dexamethasone added as an adjuvant to local
        anaesthetic agent in suprainguinal fascia iliaca block for effective postoperative analgesia
        after knee arthroplasty would prolong the duration of sensory block and reduce postoperative
        pain intensity and analgesic consumption.
  Total knee arthroplasty is one of the major orthopedic surgeries that cause severe
        postoperative pain. A successful post-operative outcome is possible with strong and effective
        pain control followed by early mobilization and a good functional recovery. Suprainguinal
        fascia iliaca plan block (SFIB) has been shown to be an effective postoperative method in
        multimodal analgesia regime in lower extremity surgery. It has been reported in the
        literature that dexamethasone added to local anaesthetics in peripheral nerve blocks prolongs
        the duration of sensory block, improves the quality of analgesia, reduces postoperative pain
        intensity and opioid consumption.
  
        In this study, the investigators aimed to demonstrate that dexamethasone added as an adjuvant
        to local anaesthetic agent in SFIB for effective postoperative analgesia after knee
        arthroplasty would prolong the duration of sensory block and reduce postoperative pain
        intensity and analgesic consumption.
  
        An identification number will be randomly assigned to each participants, whose written
        consent was obtained before the surgery, when they are admitted to the postoperative recovery
        room. In the postoperative period, participants will be followed up with these numbers. Which
        group the participants will be included in will be determined by the closed envelope method.
  
        Participants undergoing unilateral knee arthroplasty will be included in the study. Following
        the end of surgery, the participants will be divided into two groups in the recovery room and
        SFIB will be applied to both groups. Participants in group SFIB will receive 0.25%
        bupivacaine as local anaesthetic. Participants in group SFIB+dexamethasone will receive 0.25%
        bupivacaine as local anaesthetic and 8 mg dexamethasone as adjuvant.
  
        The participant with the block will be followed in the recovery room and if the block is
        successful, morphine patient controlled analgesia (PCA) treatment will be started and the
        participant will be taken to the ward. A standard analgesia regimen (1 g iv paracetamol every
        8 hours, 50 mg iv dexketoprofen every 12 hours) was used in all participants.
  
        Evaluation of postoperative pain will be done with numerical rating scale (NRS). Pain levels
        will be questioned in two different ways as rest and passive moving.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.
  measure: Postoperative opioid consumption
  time frame: Postoperative 24 hours
  description: First 24 hours total morphine consumption with patient controlled analgesia
  measure: Numerical Rating Scale
  time frame: Postoperative 24 hours
  description: To determine the pain of the patients at rest and passive-active moving at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain.
  measure: Timed up and go test (TUG)
  time frame: at 24th hour
  description: TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again
  measure: Quadriceps muscle strength
  time frame: at 24th hour
  description: will be evaluated in a scale between 1-5 (1:lowest; 5:normal)
  arm group label: Group SFIB (Suprainguinal fascia iliaca block)
  arm group type: Active Comparator
  description: In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic into this space.
  arm group label: Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)
  arm group type: Active Comparator
  description: In the patient lying in the supine position, a high-frequency linear probe is inserted under sterile conditions, using an in-plane technique, 1 cm cephalad of the inguinal ligament with a needle. Using hydro-dissection, the fascia iliaca is separated from the iliac muscle and a space is created where the needle can be advanced cranially, and the procedure will be completed by injecting local anesthetic+dexamethasone into this space.
  intervention type: Procedure
  intervention name: Suprainguinal fascia iliaca block
  description: After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.
  arm group label: Group SFIB (Suprainguinal fascia iliaca block)
  intervention type: Procedure
  intervention name: Suprainguinal fascia iliaca block+dexamethasone
  description: After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic+dexamethasone injection will be made between the fascia and the muscle.
  arm group label: Group SFIB+dexa (Suprainguinal fascia iliaca block+dexamethasone)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Mustafa Süren, Professor
  role: Study Chair
  affiliation: Samsun Research and Education Hospital
  last name: Hale Kefeli Celik, MD
  phone: +905057242409
  email: ck_hale@hotmail.com
  last name: Elif Colak, Professor
  phone: +905323754163
  email: elifmangancolak@hotmail.com
  facility: 
  country: Turkey
  citation: Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
  PMID: 28861197
  citation: Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.
  PMID: 31272654
  citation: Vermeylen K, Soetens F, Leunen I, Hadzic A, Van Boxtael S, Pomes J, Prats-Galino A, Van de Velde M, Neyrinck A, Sala-Blanch X. The effect of the volume of supra-inguinal injected solution on the spread of the injectate under the fascia iliaca: a preliminary study. J Anesth. 2018 Dec;32(6):908-913. doi: 10.1007/s00540-018-2558-9. Epub 2018 Sep 24.
  PMID: 30250982
  citation: Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.
  PMID: 29121400
  responsible party type: Principal Investigator
  investigator affiliation: Samsun Education and Research Hospital
  investigator full name: Hale Kefeli Celik
  investigator title: Anesthesiologist, Principal Investigator
  mesh term: Pain, Postoperative
  mesh term: Dexamethasone
  sharing ipd: No
  ipd description: Researched data and statistical analyzes will be available from the journal in which the clinical study was published