<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/NCT04419701</url>
  </required_header>
  <id_info>
    <org_study_id>pain in knee arthroplasty</org_study_id>
    <nct_id>NCT04419701</nct_id>
  </id_info>
  <brief_title>Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty</brief_title>
  <official_title>Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration for Postoperative Pain in Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Effective pain relief allows the patients to obtain early knee mobilization and optimal&#xD;
      rehabilitation and thus improves the patient satisfaction.&#xD;
&#xD;
      The aim of perioperative pain control is to minimize delays in recovery, postoperative&#xD;
      delirium and pain-related stress responses that can lead to serious morbidity and poor&#xD;
      outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have&#xD;
      been evaluated, as poorly controlled acute postoperative pain can be associated with&#xD;
      persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems&#xD;
      to be closely associated with chronic post-TKA pain, with similar mechanisms underlying&#xD;
      hyperalgesia or chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic&#xD;
      department, has been a successful intervention for patients with end-stage knee arthritis.&#xD;
&#xD;
      Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery&#xD;
      on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic&#xD;
      modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain&#xD;
      without motor impairment, resulting in successful mobilization. Pain control plays an&#xD;
      essential role in the overall postoperative period for the patients undergoing TKA.&#xD;
&#xD;
      Effective pain relief allows the patients to obtain early knee mobilization and optimal&#xD;
      rehabilitation and thus improves the patient satisfaction.&#xD;
&#xD;
      The aim of perioperative pain control is to minimize delays in recovery, postoperative&#xD;
      delirium and pain-related stress responses that can lead to serious morbidity and poor&#xD;
      outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have&#xD;
      been evaluated, as poorly controlled acute postoperative pain can be associated with&#xD;
      persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems&#xD;
      to be closely associated with chronic post-TKA pain, with similar mechanisms underlying&#xD;
      hyperalgesia or chronic pain.&#xD;
&#xD;
      Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to&#xD;
      evaluate functional recovery and the success of the type of analgesia used.&#xD;
&#xD;
      Several methods such as intravenous opioids, extraarticular and intraarticular injection,&#xD;
      epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative&#xD;
      pain management.&#xD;
&#xD;
      However, each method is reported with potential side effects, for example, opioid drugs&#xD;
      caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia&#xD;
      with urinary retention, respiratory depression and spinal headache, femoral or sciatic block&#xD;
      with diminished muscle control and possible nerve damage.&#xD;
&#xD;
      Periarticular multimodal drug injection in TKA is a technique that patients received&#xD;
      intraoperative drug injection in the periarticular fields such as posterior capsule, medial&#xD;
      and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of&#xD;
      the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal&#xD;
      anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.&#xD;
&#xD;
      Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee&#xD;
      osteoarthritis with good success.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2020</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>total doses of postoperative opioid consumption</measure>
    <time_frame>postoperative first day</time_frame>
    <description>total doses of postoperative rescue morphine consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of the first dose of rescue analgesia</measure>
    <time_frame>postoperative first day</time_frame>
    <description>Time of the first dose of rescue morphine analgesia at dose of 3 mg</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Knee range of motion</measure>
    <time_frame>postoperative first day</time_frame>
    <description>The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee range of motion</measure>
    <time_frame>postoperative second day</time_frame>
    <description>The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee range of motion</measure>
    <time_frame>postoperative third day</time_frame>
    <description>The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>periarticular infiltration group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive intraoperative periarticular infitration consisting of 89.5 mL of normal saline, 20 mL of 5% bupivacaine and 0.5 mL of adrenaline (4.5 ugm/ml) with a concentration 1:220000 (total volume: 110 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>genicular nerve block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% with adrenaline 2.5 µg/ml with a concentration 1:400000 in the immediate postoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>periarticular infiltration</intervention_name>
    <description>The cocktail will be injected at the following 7 anatomical zones as follows:&#xD;
Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement.</description>
    <arm_group_label>periarticular infiltration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>genicular nerve block</intervention_name>
    <description>The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.</description>
    <arm_group_label>genicular nerve block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral knee arthroplasty surgery,&#xD;
&#xD;
          -  aged more than 50 years of both genders.&#xD;
&#xD;
          -  have american society of anesthesiologist physical status I-II and III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Revision knee arthroplasty,&#xD;
&#xD;
          -  previous surgery or trauma to knee,&#xD;
&#xD;
          -  drug allergy, regular narcotic use,&#xD;
&#xD;
          -  renal impairments&#xD;
&#xD;
          -  hepatic impairments,&#xD;
&#xD;
          -  neuromuscular diseases&#xD;
&#xD;
          -  coagulopathy disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tarek Abdel Hay</name>
      <address>
        <city>Tanta</city>
        <state>El Gharbyia</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>tarek abdel hay mostafa</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT04419701
org study id: pain in knee arthroplasty
nct id: NCT04419701
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Effective pain relief allows the patients to obtain early knee mobilization and optimal
      rehabilitation and thus improves the patient satisfaction.

      The aim of perioperative pain control is to minimize delays in recovery, postoperative
      delirium and pain-related stress responses that can lead to serious morbidity and poor
      outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have
      been evaluated, as poorly controlled acute postoperative pain can be associated with
      persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems
      to be closely associated with chronic post-TKA pain, with similar mechanisms underlying
      hyperalgesia or chronic pain.
Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic
      department, has been a successful intervention for patients with end-stage knee arthritis.

      Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery
      on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic
      modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain
      without motor impairment, resulting in successful mobilization. Pain control plays an
      essential role in the overall postoperative period for the patients undergoing TKA.

      Effective pain relief allows the patients to obtain early knee mobilization and optimal
      rehabilitation and thus improves the patient satisfaction.

      The aim of perioperative pain control is to minimize delays in recovery, postoperative
      delirium and pain-related stress responses that can lead to serious morbidity and poor
      outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have
      been evaluated, as poorly controlled acute postoperative pain can be associated with
      persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems
      to be closely associated with chronic post-TKA pain, with similar mechanisms underlying
      hyperalgesia or chronic pain.

      Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to
      evaluate functional recovery and the success of the type of analgesia used.

      Several methods such as intravenous opioids, extraarticular and intraarticular injection,
      epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative
      pain management.

      However, each method is reported with potential side effects, for example, opioid drugs
      caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia
      with urinary retention, respiratory depression and spinal headache, femoral or sciatic block
      with diminished muscle control and possible nerve damage.

      Periarticular multimodal drug injection in TKA is a technique that patients received
      intraoperative drug injection in the periarticular fields such as posterior capsule, medial
      and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of
      the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal
      anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.

      Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee
      osteoarthritis with good success.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: total doses of postoperative opioid consumption
time frame: postoperative first day
description: total doses of postoperative rescue morphine consumption
measure: Time of the first dose of rescue analgesia
time frame: postoperative first day
description: Time of the first dose of rescue morphine analgesia at dose of 3 mg
measure: Knee range of motion
time frame: postoperative first day
description: The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
measure: Knee range of motion
time frame: postoperative second day
description: The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
measure: Knee range of motion
time frame: postoperative third day
description: The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
arm group label: periarticular infiltration group
arm group type: Experimental
description: will receive intraoperative periarticular infitration consisting of 89.5 mL of normal saline, 20 mL of 5% bupivacaine and 0.5 mL of adrenaline (4.5 ugm/ml) with a concentration 1:220000 (total volume: 110 mL)
arm group label: genicular nerve block group
arm group type: Experimental
description: will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% with adrenaline 2.5 µg/ml with a concentration 1:400000 in the immediate postoperative period.
intervention type: Procedure
intervention name: periarticular infiltration
description: The cocktail will be injected at the following 7 anatomical zones as follows:
Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement.
arm group label: periarticular infiltration group
intervention type: Procedure
intervention name: genicular nerve block
description: The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.
arm group label: genicular nerve block group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: tarek abdel hay mostafa
investigator title: principle investigator
mesh term: Pain, Postoperative