<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/NCT03231319</url>
  </required_header>
  <id_info>
    <org_study_id>CF17089A</org_study_id>
    <nct_id>NCT03231319</nct_id>
  </id_info>
  <brief_title>Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty</brief_title>
  <official_title>Comparison of Different Neural Blockade Techniques in Postoperative Analgesia After Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the different analgesic protocols for patients receiving total hip&#xD;
      arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca&#xD;
      compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral&#xD;
      femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      90 patients will be enrolled and randomized to the 3 different groups.&#xD;
&#xD;
        1. Inclusion criteria:&#xD;
&#xD;
           Patient undergoing THA: 20-75 years old, ASA I-III, general anesthesia with intubation,&#xD;
           fentanyl IV PCA.&#xD;
&#xD;
        2. Exclusion criteria Alcohol/substance abuse Rheumatoid arthritis Severe coagulation&#xD;
           disorder(PLT&lt;80000 or INR &gt; 1.5) Peripheral neuropathy Allergy to opioids or local&#xD;
           anesthetics BMI&gt;35&#xD;
&#xD;
        3. The outcome followers are blinded to the intervention provided.&#xD;
&#xD;
        4. Outcome parameters:&#xD;
&#xD;
             1. Opioid consumption of IV PCA in first 24 hrs.&#xD;
&#xD;
             2. NSAID consumption&#xD;
&#xD;
             3. NRS of pain, the timings of follow-up should be: pre-block, 30&#xD;
&#xD;
                mins post-block, 60 mins post-block, 2 hours post-block, 24hours post-block&#xD;
&#xD;
             4. sensory block in FN, Obturator Nerve and LFCN&#xD;
&#xD;
             5. First request of supplemental IV analgesia&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 27, 2017</start_date>
  <completion_date type="Anticipated">April 19, 2018</completion_date>
  <primary_completion_date type="Anticipated">April 19, 2018</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temporal changes of Pain score</measure>
    <time_frame>1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.</time_frame>
    <description>Pain score by numerical rating scale from pre-intervention to 24 hours after intervention(the effect of neural blockade seldom lasts more than 24 hours)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumptions</measure>
    <time_frame>postoperatively 24 hours</time_frame>
    <description>Including IV-PCA and other analgesics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area</measure>
    <time_frame>1 hour post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NSAID consumptions</measure>
    <time_frame>24 hours postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>fascia iliaca compartment block+ IV-PCA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>femoral nerve and lateral femoral cutaneous nerve block+IV PCA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>IV PCA only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fascia iliaca compartment block with IV-PCA</intervention_name>
    <description>1. Fascia iliaca compartment block: The injection was performed under ultrasound guidance. Surface landmark is identified on the line between anterior superior iliac spine and pubic tubercle. The injection site is at the medial one-third of the line. The needle is threaded medial to lateral and standardization of local anesthetic deposit is in the fascia plane between fascia iliaca and iliacus muscle. Anesthetic regimen: 2% xylocaine 15mL + 0.5% bupivacaine 15mL.</description>
    <arm_group_label>fascia iliaca compartment block+ IV-PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA</intervention_name>
    <description>Femoral nerve block: The injection was performed under ultrasound guidance. Femoral nerve was identified in the femoral neurovascular bundle below or around inguinal ligament. The needle is threaded with lateral to medial approach. Local anesthetics will be deposited around the femoral nerve, the standardization of protocol is that femoral nerve should be lifted off from iliacus muscle. Anesthetic regimen: 2% xylocaine 10mL + 0.5% bupivacaine 10mL.&#xD;
Lateral femoral cutaneous nerve block: The injection was performed under ultrasound guidance. Lateral femoral cutaneous nerve was identified in the fascia plane between sartorius muscle and tensor fascia lata muscle. Anesthetic regimen: 2% xylocaine 5mL + 0.5% bupivacaine 5mL</description>
    <arm_group_label>femoral nerve and lateral femoral cutaneous nerve block+IV PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IV-PCA</intervention_name>
    <description>IV-PCA was programmed and provided to the patient for optimize pain control</description>
    <arm_group_label>IV PCA only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III, general anesthesia with intubation.&#xD;
&#xD;
          -  fentanyl IV PCA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol/substance abuse&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Severe coagulation disorder(PLT&lt;80000 or INR &gt; 1.5)&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Allergy to opioids or local anesthetics&#xD;
&#xD;
          -  BMI&gt;35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Ting Chang, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tsung-Yung Tang, M.D.</last_name>
    <phone>+886975351575</phone>
    <email>b92401096@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chih-Cheng Wu, M.D.</last_name>
    <phone>+886975358990</phone>
    <email>chihcheng.wu@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsung-Yung Tang, M.D.</last_name>
      <phone>+886423592525</phone>
      <phone_ext>4108</phone_ext>
      <email>b92401096@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dept. of Anesthesiology, Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsung-Yung Tang, M.D.</last_name>
      <phone>+886423592525</phone>
      <phone_ext>4108</phone_ext>
      <email>b92401096@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>1. Hadzic's peripheral nerve blocks and anatomy for ultrasound-guidedregional anesthesia, 2012. Chapter.35, 36. 2. K.H. Thymo, O. Mathiesen, J.B. Dahl, et al. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomized trial. Acta Anaesthesiologica Scandinavica 60(2016) 1297-1305. 3. Shoji Nishio, Shigeo Fukunishi, Miura Juichi et al. Comparison of continuous femoral nerve block, caudal epidural block, and intravenous patient-controlled analgesia in pain control after total hip arthroplasty: a prospective randomized study. Orthopedic Reviews 2014; 6; 5138. 4. Bin Yu, Miao He, Guang-Yu Cai et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly. Medicine (2016) 95:42 5. Guay J, Parker MJ, Gajendragadkar PR, et al. Anaesthesia for hip fracture surgery in adults. Cochrane Database of Systemic Reviews 2016, issue 2, Art. No:CD000521. 6. K.H. Thybo, Harald Schmidt and Daniel Hagi-Pederson. Effect of lateral femoral cutaneous nerve block on pain after total hip arthroplasty: a randomized , blinded, placebo-controlled trail. BMC anesthesiology (2016) 16:21. 7. John Dolan, Anne Williams, Eileen Murney, et al. Ultrasound guided fascial iliaca block: a comparison with loss of resistance technique. Reg Anesth Pain Med 2008; 33: 526-31 8. Ali N. Shariat, Admir Hadzic, Daquan Xu, et al. Fascia iliaca block for analgesia after hip arthroplasty: a randomized double-blinded, placebo-controlled trial. Reg Anesth Pain Med 2013;38:201-205</citation>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>June 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03231319
org study id: CF17089A
nct id: NCT03231319
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare the different analgesic protocols for patients receiving total hip
      arthroplasty(THA). Patients will divided into 3 groups, which are 1. fascia iliaca
      compartment block with IV-PCA(patient controlled analgesia), 2. femoral nerve and lateral
      femoral cutaneous nerve block with IV-PCA, 3. IV-PCA only.
90 patients will be enrolled and randomized to the 3 different groups.

        1. Inclusion criteria:

           Patient undergoing THA: 20-75 years old, ASA I-III, general anesthesia with intubation,
           fentanyl IV PCA.

        2. Exclusion criteria Alcohol/substance abuse Rheumatoid arthritis Severe coagulation
           disorder(PLT<80000 or INR > 1.5) Peripheral neuropathy Allergy to opioids or local
           anesthetics BMI>35

        3. The outcome followers are blinded to the intervention provided.

        4. Outcome parameters:

             1. Opioid consumption of IV PCA in first 24 hrs.

             2. NSAID consumption

             3. NRS of pain, the timings of follow-up should be: pre-block, 30

                mins post-block, 60 mins post-block, 2 hours post-block, 24hours post-block

             4. sensory block in FN, Obturator Nerve and LFCN

             5. First request of supplemental IV analgesia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Temporal changes of Pain score
time frame: 1. Pre-intervention(which is the time when operation was done and the patient arrive postoperative care unit.) 2. 30 minutes after intervention, 3. 60 minutes after intervention, 4. 120 minutes after intervention, 5. 24 hours after intervention.
description: Pain score by numerical rating scale from pre-intervention to 24 hours after intervention(the effect of neural blockade seldom lasts more than 24 hours)
measure: Opioid consumptions
time frame: postoperatively 24 hours
description: Including IV-PCA and other analgesics
measure: Sensory block in femoral nerve, obturator nerve and lateral femoral cutaneous nerve area
time frame: 1 hour post-intervention
measure: NSAID consumptions
time frame: 24 hours postoperatively
arm group label: fascia iliaca compartment block+ IV-PCA
arm group type: Active Comparator
arm group label: femoral nerve and lateral femoral cutaneous nerve block+IV PCA
arm group type: Active Comparator
arm group label: IV PCA only
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: Fascia iliaca compartment block with IV-PCA
description: 1. Fascia iliaca compartment block: The injection was performed under ultrasound guidance. Surface landmark is identified on the line between anterior superior iliac spine and pubic tubercle. The injection site is at the medial one-third of the line. The needle is threaded medial to lateral and standardization of local anesthetic deposit is in the fascia plane between fascia iliaca and iliacus muscle. Anesthetic regimen: 2% xylocaine 15mL + 0.5% bupivacaine 15mL.
arm group label: fascia iliaca compartment block+ IV-PCA
intervention type: Procedure
intervention name: Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA
description: Femoral nerve block: The injection was performed under ultrasound guidance. Femoral nerve was identified in the femoral neurovascular bundle below or around inguinal ligament. The needle is threaded with lateral to medial approach. Local anesthetics will be deposited around the femoral nerve, the standardization of protocol is that femoral nerve should be lifted off from iliacus muscle. Anesthetic regimen: 2% xylocaine 10mL + 0.5% bupivacaine 10mL.
Lateral femoral cutaneous nerve block: The injection was performed under ultrasound guidance. Lateral femoral cutaneous nerve was identified in the fascia plane between sartorius muscle and tensor fascia lata muscle. Anesthetic regimen: 2% xylocaine 5mL + 0.5% bupivacaine 5mL
arm group label: femoral nerve and lateral femoral cutaneous nerve block+IV PCA
intervention type: Procedure
intervention name: IV-PCA
description: IV-PCA was programmed and provided to the patient for optimize pain control
arm group label: IV PCA only
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yi-Ting Chang, M.D.
role: Study Chair
affiliation: Taichung Veterans General Hospital
last name: Tsung-Yung Tang, M.D.
phone: +886975351575
email: b92401096@gmail.com
last name: Chih-Cheng Wu, M.D.
phone: +886975358990
email: chihcheng.wu@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: 1. Hadzic's peripheral nerve blocks and anatomy for ultrasound-guidedregional anesthesia, 2012. Chapter.35, 36. 2. K.H. Thymo, O. Mathiesen, J.B. Dahl, et al. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomized trial. Acta Anaesthesiologica Scandinavica 60(2016) 1297-1305. 3. Shoji Nishio, Shigeo Fukunishi, Miura Juichi et al. Comparison of continuous femoral nerve block, caudal epidural block, and intravenous patient-controlled analgesia in pain control after total hip arthroplasty: a prospective randomized study. Orthopedic Reviews 2014; 6; 5138. 4. Bin Yu, Miao He, Guang-Yu Cai et al. Ultrasound-guided continuous femoral nerve block vs continuous fascia iliaca compartment block for hip replacement in the elderly. Medicine (2016) 95:42 5. Guay J, Parker MJ, Gajendragadkar PR, et al. Anaesthesia for hip fracture surgery in adults. Cochrane Database of Systemic Reviews 2016, issue 2, Art. No:CD000521. 6. K.H. Thybo, Harald Schmidt and Daniel Hagi-Pederson. Effect of lateral femoral cutaneous nerve block on pain after total hip arthroplasty: a randomized , blinded, placebo-controlled trail. BMC anesthesiology (2016) 16:21. 7. John Dolan, Anne Williams, Eileen Murney, et al. Ultrasound guided fascial iliaca block: a comparison with loss of resistance technique. Reg Anesth Pain Med 2008; 33: 526-31 8. Ali N. Shariat, Admir Hadzic, Daquan Xu, et al. Fascia iliaca block for analgesia after hip arthroplasty: a randomized double-blinded, placebo-controlled trial. Reg Anesth Pain Med 2013;38:201-205
responsible party type: Sponsor
mesh term: Pain, Postoperative