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/NCT05963139</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1481345</org_study_id>
      <nct_id>NCT05963139</nct_id>
    </id_info>
    <brief_title>Comparison of Local Anesthetic Dose in Ipack Block Performed in Knee Arthroplasty Operations</brief_title>
    <official_title>Comparison of Local Anesthetic Dose in IPACK (Interspace Between the Popliteal Artery and the Posterior Capsule of the Knee) Block Performed for Postoperative Analgesia in Knee Artroplasty Operations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul 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>
        The investigators research was designed as a single-center, prospective, randomized study.&#xD;
        The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine&#xD;
        Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally&#xD;
        authorized to make decisions on their behalf will be informed about the research and their&#xD;
        written consent will be obtained. Patients who do not give consent will not be included in&#xD;
        the study.&#xD;
  &#xD;
        Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block&#xD;
        needle after compliance with the rules of asepsia and antisepsis in the supine position&#xD;
        according to the group of patients in which they were included.&#xD;
  &#xD;
        IPACK and adductor block will be done for postoperative analgesia. After then, a single dose&#xD;
        of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,&#xD;
        using the appropriate spinal needle, as is routinely applied in the investigators clinic.&#xD;
        After the block is completed, the pinprick test will be done and the operation will be&#xD;
        started after the successful completion of the block is confirmed. Oxygen will be given to&#xD;
        the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation,&#xD;
        invasive / noninvasive blood pressure monitoring of the patients will be done.&#xD;
  &#xD;
        In the investigators clinic, the use of IPACK block, adductor block and PCA (patient&#xD;
        controlled analgesia) device with intravenous morphine for postoperative analgesia is&#xD;
        routinely performed. In this study, four randomized groups will be formed together with the&#xD;
        control group.&#xD;
  &#xD;
        IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd&#xD;
        group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%&#xD;
        bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and&#xD;
        PCA (patient controlled analgesia) device with intravenous morphine for postoperative&#xD;
        analgesia is performed.&#xD;
  &#xD;
        Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at&#xD;
        the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with&#xD;
        intravenous morphine applied in routine practice to all four groups. As in routine practice,&#xD;
        when NRS &gt; 4 after each interrogation, morphine 2 mg iv will be administered as additional&#xD;
        analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS&#xD;
        &lt; 4.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators research was designed as a single-center, prospective, randomized study.&#xD;
  &#xD;
        The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty&#xD;
        Department of Orthopedics and Traumatology will be included. Patients who are legally&#xD;
        authorized to make decisions on their behalf will be informed about the research and their&#xD;
        written consent will be obtained. Patients who do not give consent will not be included in&#xD;
        the study.&#xD;
  &#xD;
        Patients will be evaluated preoperative before surgery, a detailed history will be taken and&#xD;
        physical examination will be carried out. Medical and surgical resume information will be&#xD;
        obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken&#xD;
        to the operating room after premedication.&#xD;
  &#xD;
        ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room.&#xD;
        Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block&#xD;
        needle after compliance with the rules of asepsia and antisepsis in the supine position&#xD;
        according to the group of patients in which they were included.&#xD;
  &#xD;
        IPACK and adductor block will be done for postoperative analgesia. After then, a single dose&#xD;
        of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,&#xD;
        using the appropriate spinal needle, as is routinely applied in the investigators clinic.&#xD;
        After the block is completed, the pinprick test will be done and the operation will be&#xD;
        started after the successful completion of the block is confirmed. Oxygen will be given to&#xD;
        the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation,&#xD;
        invasive / noninvasive blood pressure monitoring of the patients will be done.&#xD;
  &#xD;
        In the investigators clinic, the use of IPACK block, adductor block and PCA (patient&#xD;
        controlled analgesia) device with intravenous morphine for postoperative analgesia is&#xD;
        routinely performed. In this study, four randomized groups will be formed together with the&#xD;
        control group.Computer-generated random numbers will be used for simple randomization of&#xD;
        patients.&#xD;
  &#xD;
        IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd&#xD;
        group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%&#xD;
        bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and&#xD;
        PCA (patient controlled analgesia) device with intravenous morphine for postoperative&#xD;
        analgesia is performed.&#xD;
  &#xD;
        Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at&#xD;
        the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with&#xD;
        intravenous morphine applied in routine practice to all four groups. As in routine practice,&#xD;
        when NRS &gt; 4 after each interrogation, morphine 2 mg iv will be administered as additional&#xD;
        analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS&#xD;
        &lt; 4.&#xD;
  &#xD;
        Patients are followed up in the service for 48 hours postoperatively in routine practice.&#xD;
  &#xD;
        In the postoperative period, patients will be evaluated in terms of additional nausea and&#xD;
        vomiting,amount of morphine consumed and additional analgesic need postoperative period up to&#xD;
        48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis&#xD;
        index and joint range of motion will be evaluated at preoperative period and at the discharge&#xD;
        day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower&#xD;
        extremity will be evaluated preoperative period, at postoperative 24th hour and at the&#xD;
        discharge day from the hospital.&#xD;
  &#xD;
        Postop patient satisfaction and surgical satisfaction with Likert scale will also be&#xD;
        evaluated at postoperative period.&#xD;
  &#xD;
        During the procedure, complications such as failed block, nerve damage, vascular injury,&#xD;
        intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions&#xD;
        will be recorded.&#xD;
  &#xD;
        Before the study, it was determined that at least 112 patients should be collected in the&#xD;
        power analysis performed with the help of similar literature data. After collecting the&#xD;
        demographic data and morphine consumption data of the patients, the data will be transferred&#xD;
        to the statistical program called SPSS and statistical analysis will be made.The&#xD;
        investigators study does not contain any modifications other than the investigators daily&#xD;
        routine practices.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">November 10, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale(0-10)pain scores for patients.</measure>
      <time_frame>postoperative period up to 48 hours</time_frame>
      <description>NRS(Numeric Rating Scale),0:no pain,10:the worst pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Opioid (mg) consumption</measure>
      <time_frame>postoperative period up to 48th hours</time_frame>
      <description>Opioid (mg) consumption</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of side effects</measure>
      <time_frame>postoperative period up to 48th hours</time_frame>
      <description>Incidence of nausea and vomiting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time until postoperative first mobilization</measure>
      <time_frame>Up to 48 hours</time_frame>
      <description>First mobilization time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>Through study completion, an average of 1 week.</time_frame>
      <description>Hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Womac osteoarthritis index</measure>
      <time_frame>Discharge 1 day from the hospital</time_frame>
      <description>Womac osteoarthritis index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity</measure>
      <time_frame>Discharge 1 day from the hospital</time_frame>
      <description>The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Joint range of motion</measure>
      <time_frame>Postoperative period up to 48th hours, discharge 1 day</time_frame>
      <description>Joint range of motion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>Postoperative period up to 48th hours</time_frame>
      <description>Satisfaction score;0-very unsatisfied,5-very satisfied.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgeon satisfaction</measure>
      <time_frame>Postoperative period up to 48th hours</time_frame>
      <description>Satisfaction score;0-very unsatisfied,5-very satisfied.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Analgesia</condition>
    <condition>Pain, Postoperative</condition>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine</intervention_name>
      <description>US guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine.</description>
      <arm_group_label>Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia</arm_group_label>
      <other_name>Marcaine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Morphine Sulfate</intervention_name>
      <description>In this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine.</description>
      <arm_group_label>Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block</arm_group_label>
      <arm_group_label>Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia</arm_group_label>
      <other_name>morphine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients scheduled for knee arthroplasty surgery under regional anesthesia&#xD;
  &#xD;
            -  ASA(American Society of Anesthesiology) 1-3&#xD;
  &#xD;
            -  Receiving consent that accept regional analgesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of regional anesthesia&#xD;
  &#xD;
            -  Infection on the local anesthetic application area&#xD;
  &#xD;
            -  Infection in the central nervous system&#xD;
  &#xD;
            -  Coagulopathy&#xD;
  &#xD;
            -  BMI &gt; 40&#xD;
  &#xD;
            -  Known allergy against local anesthetics&#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>GÜLBERK KILIÇ, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Faculty of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>NUR CANBOLAT, MD</last_name>
      <phone>+90 532 516 25 83</phone>
      <email>drnurekiz@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul University Istanbul Medical Faculty</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nur Canbolat, Dr</last_name>
        <email>drnurekiz@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.</citation>
      <PMID>33915199</PMID>
    </reference>
    <reference>
      <citation>Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.</citation>
      <PMID>30234517</PMID>
    </reference>
    <reference>
      <citation>Patterson ME, Vitter J, Bland K, Nossaman BD, Thomas LC, Chimento GF. The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S173-S177. doi: 10.1016/j.arth.2020.01.014. Epub 2020 Jan 15.</citation>
      <PMID>32005622</PMID>
    </reference>
    <reference>
      <citation>D'Souza RS, Langford BJ, Olsen DA, Johnson RL. Ultrasound-Guided Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK) Block for Primary Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. Local Reg Anesth. 2021 May 12;14:85-98. doi: 10.2147/LRA.S303827. eCollection 2021.</citation>
      <PMID>34012290</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University</investigator_affiliation>
      <investigator_full_name>Nur Canbolat</investigator_full_name>
      <investigator_title>Principal Investigator, M.D.</investigator_title>
    </responsible_party>
    <keyword>IPACK block</keyword>
    <keyword>Postoperative Pain</keyword>
    <keyword>Postoperative Patient Controlled Analgesia</keyword>
    <keyword>Knee Artroplasty</keyword>
    <keyword>Regional Anesthesia</keyword>
    <keyword>Numeric rating scale</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>Morphine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05963139
  org study id: 2022-1481345
  nct id: NCT05963139
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators research was designed as a single-center, prospective, randomized study.
        The patients undergoing knee artrhroplasty surgery in Istanbul University Istanbul Medicine
        Faculty Department of Orthopedics and Traumatology will be included. Patients who are legally
        authorized to make decisions on their behalf will be informed about the research and their
        written consent will be obtained. Patients who do not give consent will not be included in
        the study.
  
        Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block
        needle after compliance with the rules of asepsia and antisepsis in the supine position
        according to the group of patients in which they were included.
  
        IPACK and adductor block will be done for postoperative analgesia. After then, a single dose
        of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,
        using the appropriate spinal needle, as is routinely applied in the investigators clinic.
        After the block is completed, the pinprick test will be done and the operation will be
        started after the successful completion of the block is confirmed. Oxygen will be given to
        the patients with a face mask at 4 lt / min throughout the operation. ECG, saturation,
        invasive / noninvasive blood pressure monitoring of the patients will be done.
  
        In the investigators clinic, the use of IPACK block, adductor block and PCA (patient
        controlled analgesia) device with intravenous morphine for postoperative analgesia is
        routinely performed. In this study, four randomized groups will be formed together with the
        control group.
  
        IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd
        group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%
        bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and
        PCA (patient controlled analgesia) device with intravenous morphine for postoperative
        analgesia is performed.
  
        Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at
        the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with
        intravenous morphine applied in routine practice to all four groups. As in routine practice,
        when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional
        analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS
        < 4.
  The investigators research was designed as a single-center, prospective, randomized study.
  
        The patients undergoing knee arthroplasty in Istanbul University Istanbul Medicine Faculty
        Department of Orthopedics and Traumatology will be included. Patients who are legally
        authorized to make decisions on their behalf will be informed about the research and their
        written consent will be obtained. Patients who do not give consent will not be included in
        the study.
  
        Patients will be evaluated preoperative before surgery, a detailed history will be taken and
        physical examination will be carried out. Medical and surgical resume information will be
        obtained. Patients' NRS scores will be recorded before the operation. Patients will be taken
        to the operating room after premedication.
  
        ECG, pulse oximeter, blood pressure monitoring will be performed in the operating room.
        Patients will be given US guided IPACK and adductor blocks using a 22 gauge 10 mm block
        needle after compliance with the rules of asepsia and antisepsis in the supine position
        according to the group of patients in which they were included.
  
        IPACK and adductor block will be done for postoperative analgesia. After then, a single dose
        of spinal anesthesia will be applied as a regional anesthesia method, in a sitting position,
        using the appropriate spinal needle, as is routinely applied in the investigators clinic.
        After the block is completed, the pinprick test will be done and the operation will be
        started after the successful completion of the block is confirmed. Oxygen will be given to
        the patients with a face mask at 4 lt / min throughout the operation.ECG, saturation,
        invasive / noninvasive blood pressure monitoring of the patients will be done.
  
        In the investigators clinic, the use of IPACK block, adductor block and PCA (patient
        controlled analgesia) device with intravenous morphine for postoperative analgesia is
        routinely performed. In this study, four randomized groups will be formed together with the
        control group.Computer-generated random numbers will be used for simple randomization of
        patients.
  
        IPACK block will be applied to the 1st group with 10 ml of 0.25% bupivacaine, to the 2nd
        group with 15 ml of 0.25% bupivacaine, and to the 3rd group with 20 ml of 0.25%
        bupivacaine.Adductor block will be applied to all the groups with 15 ml %0,25 bupivacaine and
        PCA (patient controlled analgesia) device with intravenous morphine for postoperative
        analgesia is performed.
  
        Pain score and total morphine consumption will be determined by numeric rating scale (NRS) at
        the postoperative 1, 4, 8, 12, 24 and 48th hours by providing the use of a PCA device with
        intravenous morphine applied in routine practice to all four groups. As in routine practice,
        when NRS > 4 after each interrogation, morphine 2 mg iv will be administered as additional
        analgesia and the maximum will be increased to 10 mg. Pain management will continue when NRS
        < 4.
  
        Patients are followed up in the service for 48 hours postoperatively in routine practice.
  
        In the postoperative period, patients will be evaluated in terms of additional nausea and
        vomiting,amount of morphine consumed and additional analgesic need postoperative period up to
        48 hours.First mobilization time, hospitalization time will be evaluated.Womac osteoarthritis
        index and joint range of motion will be evaluated at preoperative period and at the discharge
        day from the hospital.The Medical Research Council (MRC) Scale for Muscle Strength for lower
        extremity will be evaluated preoperative period, at postoperative 24th hour and at the
        discharge day from the hospital.
  
        Postop patient satisfaction and surgical satisfaction with Likert scale will also be
        evaluated at postoperative period.
  
        During the procedure, complications such as failed block, nerve damage, vascular injury,
        intravenous injection of local anesthetic, local anesthetic toxicity and allergic reactions
        will be recorded.
  
        Before the study, it was determined that at least 112 patients should be collected in the
        power analysis performed with the help of similar literature data. After collecting the
        demographic data and morphine consumption data of the patients, the data will be transferred
        to the statistical program called SPSS and statistical analysis will be made.The
        investigators study does not contain any modifications other than the investigators daily
        routine practices.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Numeric Rating Scale(0-10)pain scores for patients.
  time frame: postoperative period up to 48 hours
  description: NRS(Numeric Rating Scale),0:no pain,10:the worst pain.
  measure: Opioid (mg) consumption
  time frame: postoperative period up to 48th hours
  description: Opioid (mg) consumption
  measure: Incidence of side effects
  time frame: postoperative period up to 48th hours
  description: Incidence of nausea and vomiting
  measure: Time until postoperative first mobilization
  time frame: Up to 48 hours
  description: First mobilization time
  measure: Length of hospital stay
  time frame: Through study completion, an average of 1 week.
  description: Hospitalization
  measure: Womac osteoarthritis index
  time frame: Discharge 1 day from the hospital
  description: Womac osteoarthritis index
  measure: The Medical Research Council (MRC) Scale for Muscle Strength for lower extremity
  time frame: Discharge 1 day from the hospital
  description: The Medical Research Council (MRC) Scale for Muscle Strength is a commonly used scale for assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
  measure: Joint range of motion
  time frame: Postoperative period up to 48th hours, discharge 1 day
  description: Joint range of motion
  measure: Patient satisfaction
  time frame: Postoperative period up to 48th hours
  description: Satisfaction score;0-very unsatisfied,5-very satisfied.
  measure: Surgeon satisfaction
  time frame: Postoperative period up to 48th hours
  description: Satisfaction score;0-very unsatisfied,5-very satisfied.
  arm group label: Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group type: Active Comparator
  description: In this group,US guided IPACK block will be performed with 10 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
  arm group label: Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group type: Active Comparator
  description: In this group,US guided IPACK block will be performed with 15 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
  arm group label: Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group type: Active Comparator
  description: In this group,US guided IPACK block will be performed with 20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle.
  arm group label: Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
  arm group type: Active Comparator
  description: In this group adductor block will be performed with 15 ml %0.25 bupivacaine using a 22 gauge 10 mm block needle and postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.
  intervention type: Drug
  intervention name: Bupivacaine
  description: US guided IPACK block will be performed with 10/15/20 ml %0,25 bupivacaine and adductor block will be performed with 15 ml %0,25 bupivacaine.
  arm group label: Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
  other name: Marcaine
  intervention type: Drug
  intervention name: Morphine Sulfate
  description: In this group,adductor block will be performed with 15 ml %0,25 bupivacaine using a 22 gauge 10 mm block needle and patients will be postoperatively administered patient controlled analgesia with morphine.
  arm group label: Group 1:10 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 2:15 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 3:20 ml %0,25 bupivacaine ıpack and 15 ml %0,25 bupivacaine adductor block
  arm group label: Group 4:15 ml %0,25 bupivacaine adductor block and intravenous patient controlled analgesia
  other name: morphine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: GÜLBERK KILIÇ, MD
  role: Principal Investigator
  affiliation: Istanbul Faculty of Medicine
  last name: NUR CANBOLAT, MD
  phone: +90 532 516 25 83
  email: drnurekiz@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Zheng FY, Liu YB, Huang H, Xu S, Ma XJ, Liu YZ, Chu HC. The impact of IPACK combined with adductor canal block under ultrasound guidance on early motor function after total knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):110-114. doi: 10.1016/j.bjane.2021.04.012. Epub 2021 Apr 26.
  PMID: 33915199
  citation: Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
  PMID: 30234517
  citation: Patterson ME, Vitter J, Bland K, Nossaman BD, Thomas LC, Chimento GF. The Effect of the IPACK Block on Pain After Primary TKA: A Double-Blinded, Prospective, Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S173-S177. doi: 10.1016/j.arth.2020.01.014. Epub 2020 Jan 15.
  PMID: 32005622
  citation: D'Souza RS, Langford BJ, Olsen DA, Johnson RL. Ultrasound-Guided Local Anesthetic Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee (IPACK) Block for Primary Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. Local Reg Anesth. 2021 May 12;14:85-98. doi: 10.2147/LRA.S303827. eCollection 2021.
  PMID: 34012290
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University
  investigator full name: Nur Canbolat
  investigator title: Principal Investigator, M.D.
  mesh term: Pain, Postoperative
  mesh term: Morphine
  mesh term: Bupivacaine