<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/NCT04506879</url>
  </required_header>
  <id_info>
    <org_study_id>CREC.2020.314</org_study_id>
    <nct_id>NCT04506879</nct_id>
  </id_info>
  <brief_title>Popliteal SNB:Evaluation of Block Dynamics After Subparaneural Injection Below CPN &amp; TN</brief_title>
  <official_title>Ultrasound Guided Popliteal Sciatic Nerve Block: Evaluation of Block Dynamics After a Twin Subparaneural Injection Below the Divergence of Common Peroneal and Tibial Nerve.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      This study aims to assess the effect of twin subparaneural injection into individual&#xD;
      paraneural sheaths of Common Peroneal Nerve (CPN) and Tibial Nerve (TN) below their point of&#xD;
      divergence from the sciatic nerve on the sensory motor blockade after Popliteal Sciatic Nerve&#xD;
      Block (PSNB) at the popliteal fossa (back of the thigh) for patients requiring lower limb&#xD;
      surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound (US) guided Popliteal Sciatic Nerve Block (PSNB) has been routinely used to&#xD;
      provide surgical anaesthesia for ankle and foot surgeries, and the introduction of ultrasound&#xD;
      (US) guidance has improved the ease and accuracy of performing PSNB. However, the challenge&#xD;
      of achieving the optimal 'readiness for surgery' time after the US guided PSNB continues to&#xD;
      confront anaesthesiologists. Cumulative evidence indicates that a subparaneural PSNB improves&#xD;
      sensory motor block outcome when compared to subepimyseal PSNB where the local anaesthetic is&#xD;
      deposited outside the paraneural sheath.&#xD;
&#xD;
      While these are encouraging results, producing sensory motor blockade, i.e. surgical&#xD;
      anaesthesia in the area innervated by the sciatic nerve within 30 minutes of local&#xD;
      anaesthetic (LA) injection, after a subparaneural PSNB, remains a challenge with the success&#xD;
      rate varying from 62-92%. Reasons for this shortcoming, despite LA being deposited in&#xD;
      subparaneural space, close to the epineurium of the sciatic nerve, is probably multifactorial&#xD;
      as the nerve size, surface area exposed to local anaesthetic, and internal architecture (the&#xD;
      connective tissue component) of the sciatic nerve and its branches are all seems to influence&#xD;
      block onset time and completeness. It was observed from our clinical practice that distal&#xD;
      subparaneural injection (twin halo) into individual paraneural sheaths of common peroneal&#xD;
      nerve (CPN) and tibial nerve (TN) below the point of divergence at the popliteal fossa&#xD;
      demonstrated a faster sensory motor blockade after PSNB. Therefore, this study aims to assess&#xD;
      the effect of twin subparaneural injection into individual paraneural sheaths of CPN and TN&#xD;
      below their point of divergence from the sciatic nerve on the sensory motor blockade after&#xD;
      PSNB at the popliteal fossa.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2021</start_date>
  <completion_date type="Actual">July 16, 2023</completion_date>
  <primary_completion_date type="Actual">June 16, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the percentage of patients with complete sensory and motor block at 30 min</measure>
    <time_frame>within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45 min)</time_frame>
    <description>VRS=0 for both sensory and motor score at 30 min. The extent of the sensory blockade will be graded according to VRS (verbal rating scale) for sensory assessment (100 = normal sensation to 0 = no sensation) in the areas innervated by the sciatic nerve. Motor blockade of the deep peroneal nerve (dorsal flexion of the ankle) and tibial nerve (plantar flexion of the ankle) will be graded using a 3-point scale: 2 = normal, 1 = paresis, and 0 = paralysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The time taken to complete sensory and motor blockade at 30 min, time to 'readiness for surgery'</measure>
    <time_frame>within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45min)</time_frame>
    <description>The time point where the sensory block was =&lt; 30 VRS (VRS 0-100, 100=normal sensation and 0= no sensation) and a motor blockade of =&lt; 1 (2=normal, 1=paresis, 0=paralysis),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of the block</measure>
    <time_frame>within 45 minutes after the block (at 5min, 10min, 15min, 20min, 25min, 30min, 45min)</time_frame>
    <description>complete abolition of sensation to cold and paralysis of the muscles in the ipsilateral calf and foot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>from immediately after the block till 24 hours afterwards</time_frame>
    <description>any local anesthetic toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paraesthesia and degree of discomfort</measure>
    <time_frame>during the block</time_frame>
    <description>Paresthesia (yes or no); degree if discomfort (numeric rating scale 0-100)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Musculoskeletal Diseases or Conditions</condition>
  <arm_group>
    <arm_group_label>Popliteal Sciatic Nerve block</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will lie on their chest on the examination couch with both feet rested on the pillow to relax their lower extremity. Ultrasound scan of the nerves in popliteal fossa will be identified and then local anesthetic agents [1.5% lidocaine with 1:200,000 adrenaline and 0.5ml of 8.4% sodium bicarbonate (total 30ml)] will be injected close to the nerves (Common peroneal nerve and tibial nerve). The injections below the bifurcation near the two nerves are expected to produce quicker block than the injections above the bifurcation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Popliteal Sciatic nerve block</intervention_name>
    <description>Patients schedule for lower limb surgery under regional anesthesia will receive ultrasound guided subparaneural popliteal sciatic nerve block. After identification of the common peroneal nerve and tibial nerve, local anesthetic agents will be injected close to each nerve below the point of divergence at the popliteal fossa. The spread of the drug and the sensory and motor function of that limb will be assessed regularly till it is ready for surgery.</description>
    <arm_group_label>Popliteal Sciatic Nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo&#xD;
             elective foot and/or ankle surgery under regional anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal, ASA physical status &gt; Ⅲ, pregnancy, neuromuscular disorder, prior&#xD;
             surgery in the popliteal fossa, coagulopathy, allergy to local anaesthetic drugs, and&#xD;
             skin infection at the site of needle insertion.&#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>Manoj K Karmakar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof Manoj K Karmakar</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Popliteal Sciatic nerve block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT04506879
org study id: CREC.2020.314
nct id: NCT04506879
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the effect of twin subparaneural injection into individual
      paraneural sheaths of Common Peroneal Nerve (CPN) and Tibial Nerve (TN) below their point of
      divergence from the sciatic nerve on the sensory motor blockade after Popliteal Sciatic Nerve
      Block (PSNB) at the popliteal fossa (back of the thigh) for patients requiring lower limb
      surgeries.
Ultrasound (US) guided Popliteal Sciatic Nerve Block (PSNB) has been routinely used to
      provide surgical anaesthesia for ankle and foot surgeries, and the introduction of ultrasound
      (US) guidance has improved the ease and accuracy of performing PSNB. However, the challenge
      of achieving the optimal 'readiness for surgery' time after the US guided PSNB continues to
      confront anaesthesiologists. Cumulative evidence indicates that a subparaneural PSNB improves
      sensory motor block outcome when compared to subepimyseal PSNB where the local anaesthetic is
      deposited outside the paraneural sheath.

      While these are encouraging results, producing sensory motor blockade, i.e. surgical
      anaesthesia in the area innervated by the sciatic nerve within 30 minutes of local
      anaesthetic (LA) injection, after a subparaneural PSNB, remains a challenge with the success
      rate varying from 62-92%. Reasons for this shortcoming, despite LA being deposited in
      subparaneural space, close to the epineurium of the sciatic nerve, is probably multifactorial
      as the nerve size, surface area exposed to local anaesthetic, and internal architecture (the
      connective tissue component) of the sciatic nerve and its branches are all seems to influence
      block onset time and completeness. It was observed from our clinical practice that distal
      subparaneural injection (twin halo) into individual paraneural sheaths of common peroneal
      nerve (CPN) and tibial nerve (TN) below the point of divergence at the popliteal fossa
      demonstrated a faster sensory motor blockade after PSNB. Therefore, this study aims to assess
      the effect of twin subparaneural injection into individual paraneural sheaths of CPN and TN
      below their point of divergence from the sciatic nerve on the sensory motor blockade after
      PSNB at the popliteal fossa.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the percentage of patients with complete sensory and motor block at 30 min
time frame: within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45 min)
description: VRS=0 for both sensory and motor score at 30 min. The extent of the sensory blockade will be graded according to VRS (verbal rating scale) for sensory assessment (100 = normal sensation to 0 = no sensation) in the areas innervated by the sciatic nerve. Motor blockade of the deep peroneal nerve (dorsal flexion of the ankle) and tibial nerve (plantar flexion of the ankle) will be graded using a 3-point scale: 2 = normal, 1 = paresis, and 0 = paralysis.
measure: The time taken to complete sensory and motor blockade at 30 min, time to 'readiness for surgery'
time frame: within 45 minutes after the block (at 5min, 10min, 15min, 20 min, 25min, 30min, 45min)
description: The time point where the sensory block was =< 30 VRS (VRS 0-100, 100=normal sensation and 0= no sensation) and a motor blockade of =< 1 (2=normal, 1=paresis, 0=paralysis),
measure: Success rate of the block
time frame: within 45 minutes after the block (at 5min, 10min, 15min, 20min, 25min, 30min, 45min)
description: complete abolition of sensation to cold and paralysis of the muscles in the ipsilateral calf and foot
measure: Complication
time frame: from immediately after the block till 24 hours afterwards
description: any local anesthetic toxicity
measure: Paraesthesia and degree of discomfort
time frame: during the block
description: Paresthesia (yes or no); degree if discomfort (numeric rating scale 0-100)
arm group label: Popliteal Sciatic Nerve block
arm group type: Other
description: Patients will lie on their chest on the examination couch with both feet rested on the pillow to relax their lower extremity. Ultrasound scan of the nerves in popliteal fossa will be identified and then local anesthetic agents [1.5% lidocaine with 1:200,000 adrenaline and 0.5ml of 8.4% sodium bicarbonate (total 30ml)] will be injected close to the nerves (Common peroneal nerve and tibial nerve). The injections below the bifurcation near the two nerves are expected to produce quicker block than the injections above the bifurcation.
intervention type: Procedure
intervention name: Popliteal Sciatic nerve block
description: Patients schedule for lower limb surgery under regional anesthesia will receive ultrasound guided subparaneural popliteal sciatic nerve block. After identification of the common peroneal nerve and tibial nerve, local anesthetic agents will be injected close to each nerve below the point of divergence at the popliteal fossa. The spread of the drug and the sensory and motor function of that limb will be assessed regularly till it is ready for surgery.
arm group label: Popliteal Sciatic Nerve block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Manoj K Karmakar, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof Manoj K Karmakar
investigator title: Professor
mesh term: Musculoskeletal Diseases