<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/NCT01680692</url>
  </required_header>
  <id_info>
    <org_study_id>E12094</org_study_id>
    <nct_id>NCT01680692</nct_id>
  </id_info>
  <brief_title>Continuous Femoral and Tibial Nerve Blocks in TKA Patients</brief_title>
  <official_title>A Prospective, Randomized Study Comparing Continuous Femoral and Tibial Nerve Blocks vs. Continuous Femoral and Single Shot Sciatic Nerve Block in Total Knee Arthroplasties.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center, El Paso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Tech University Health Sciences Center, El Paso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate whether a new regional anesthesia technique would&#xD;
      provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot&#xD;
      drop after knee replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare and measure the effects of Ropivicaine given through&#xD;
      catheters located in the femoral and tibial nerves on indices of sensory blockade after total&#xD;
      knee arthroplasties. This is a randomized, prospective study designed to address the primary&#xD;
      research question: Does placing a continuous femoral &amp; tibial catheter infusion lead to&#xD;
      superior analgesia and patient satisfaction during the entire hospital stay? The secondary&#xD;
      research question is: Will selectively placing a continuous tibial catheter decrease the&#xD;
      episodes of transient foot drop to zero? Investigators know from own regional institutional&#xD;
      practices that by performing a continuous femoral with a single shot sciatic nerve block&#xD;
      provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to&#xD;
      experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and&#xD;
      leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by&#xD;
      blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot&#xD;
      drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement&#xD;
      of continuous catheters in the femoral and tibial nerves would provide better analgesia and&#xD;
      lead to no episodes of foot drop as compared to the patients that receive continuous femoral&#xD;
      and single shot sciatic blocks.&#xD;
&#xD;
      Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about&#xD;
      95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral&#xD;
      infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic)&#xD;
      of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started&#xD;
      post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic&#xD;
      clinic will provide a copy of the consent form to the subject so that they can review it, and&#xD;
      if interested in participating in the study, the patient can then contact the Principal&#xD;
      Investigator or Study Coordinator directly. After informed consent is obtained, patients will&#xD;
      be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1&#xD;
      will receive a pre-operative continuous femoral catheter and a post-operative single shot&#xD;
      sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL&#xD;
      (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which&#xD;
      will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous&#xD;
      femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30&#xD;
      mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by&#xD;
      infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks&#xD;
      performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under&#xD;
      ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and&#xD;
      visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either&#xD;
      Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be&#xD;
      performed under general anesthesia with laryngeal mask airway. Considering the fact that by&#xD;
      placing a selective continuous tibial catheter pre-operatively, we run the risk of the&#xD;
      catheter being the surgical field during the case. For this reason, it was decided that&#xD;
      placement after the procedure would be best. Therefore, the patient will be taken back to the&#xD;
      block room post-operatively and a continuous tibial nerve catheter or single shot (depending&#xD;
      on what group assigned) will be placed and bolused using the same technique as previously&#xD;
      described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required&#xD;
      for an observed post-operative pain control difference. In order to achieve a statistically&#xD;
      significant result to detect the previously observed difference, a sample of 38 patients in&#xD;
      each group (total of 76) would be required. Assuming a high consent rate and given the fact&#xD;
      many TKA's it is projected that this study can be completed in approximately 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Principal Investigator left institution--no subjects completed the study&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Early Phase 1</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-Operative Analgesia</measure>
    <time_frame>Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.</time_frame>
    <description>Will measure pain using visual analog scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Foot Drop</measure>
    <time_frame>Evaluated in the first 24, 48, 72 hours prior to discharge.</time_frame>
    <description>Daily lower extremity neurological examination of the foot (specifically dorsiflexion.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Evaluated every 24, 48 and 72 hours prior to discharge.</time_frame>
    <description>Patient satisfaction assessed using a daily numeric scale form (1-5 with 5 being most satisfied).</description>
  </other_outcome>
  <other_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>Evaluated every 24, 48, 72 hours prior to discharge.</time_frame>
    <description>Compare the total consumption of opioid use in study patients compared to control patients.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Analgesia in Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Continuous femoral and single shot sciatic nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive pre-operative continuous femoral catheter &amp; post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine &amp; 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous femoral and tibial peripheral nerve catheters</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive pre-operative continuous femoral catheter &amp; post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) &amp; 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivicaine</intervention_name>
    <description>Infusion of local anesthetic for post-operative analgesia.</description>
    <arm_group_label>Continuous femoral and single shot sciatic nerve block</arm_group_label>
    <arm_group_label>Continuous femoral and tibial peripheral nerve catheters</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Femoral Nerve Catheter</intervention_name>
    <description>Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.</description>
    <arm_group_label>Continuous femoral and single shot sciatic nerve block</arm_group_label>
    <arm_group_label>Continuous femoral and tibial peripheral nerve catheters</arm_group_label>
    <other_name>Continous femoral nerve catheter infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Tibial Nerve Catheter</intervention_name>
    <description>Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.</description>
    <arm_group_label>Continuous femoral and tibial peripheral nerve catheters</arm_group_label>
    <other_name>Continuous tibial nerve catheter infusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18-85 years old) undergoing elective total knee arthroplasty's&#xD;
&#xD;
          -  American Society of Anesthesiology Classification (ASA) 1, 2, or 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
               -  Under 18&#xD;
&#xD;
               -  Pregnancy&#xD;
&#xD;
               -  Presence of neurological disease or existing parasthesia&#xD;
&#xD;
               -  Diabetes&#xD;
&#xD;
               -  Chronic drug use&#xD;
&#xD;
               -  Infection of leg&#xD;
&#xD;
               -  American Society of Anesthesiology Classification (ASA) 4-6 (unstable conditions)&#xD;
&#xD;
               -  History of allergy to local anesthetics or opioids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hana Teissler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Zaki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center of El Paso, Texas Tech University Health Sciences Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://elpaso.ttuhsc.edu/som/anesthesiology/</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analgesia TKA</keyword>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Continuous femoral catheter</keyword>
  <keyword>Continuous tibial catheter</keyword>
  <keyword>Single shot sciatic</keyword>
  <!-- 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/NCT01680692
org study id: E12094
nct id: NCT01680692
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate whether a new regional anesthesia technique would
      provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot
      drop after knee replacement surgery.
The aim of this study is to compare and measure the effects of Ropivicaine given through
      catheters located in the femoral and tibial nerves on indices of sensory blockade after total
      knee arthroplasties. This is a randomized, prospective study designed to address the primary
      research question: Does placing a continuous femoral & tibial catheter infusion lead to
      superior analgesia and patient satisfaction during the entire hospital stay? The secondary
      research question is: Will selectively placing a continuous tibial catheter decrease the
      episodes of transient foot drop to zero? Investigators know from own regional institutional
      practices that by performing a continuous femoral with a single shot sciatic nerve block
      provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to
      experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and
      leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by
      blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot
      drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement
      of continuous catheters in the femoral and tibial nerves would provide better analgesia and
      lead to no episodes of foot drop as compared to the patients that receive continuous femoral
      and single shot sciatic blocks.

      Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about
      95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral
      infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic)
      of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started
      post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic
      clinic will provide a copy of the consent form to the subject so that they can review it, and
      if interested in participating in the study, the patient can then contact the Principal
      Investigator or Study Coordinator directly. After informed consent is obtained, patients will
      be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1
      will receive a pre-operative continuous femoral catheter and a post-operative single shot
      sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL
      (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which
      will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous
      femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30
      mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by
      infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks
      performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under
      ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and
      visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either
      Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be
      performed under general anesthesia with laryngeal mask airway. Considering the fact that by
      placing a selective continuous tibial catheter pre-operatively, we run the risk of the
      catheter being the surgical field during the case. For this reason, it was decided that
      placement after the procedure would be best. Therefore, the patient will be taken back to the
      block room post-operatively and a continuous tibial nerve catheter or single shot (depending
      on what group assigned) will be placed and bolused using the same technique as previously
      described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required
      for an observed post-operative pain control difference. In order to achieve a statistically
      significant result to detect the previously observed difference, a sample of 38 patients in
      each group (total of 76) would be required. Assuming a high consent rate and given the fact
      many TKA's it is projected that this study can be completed in approximately 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-Operative Analgesia
time frame: Patients pain score will be evaluated after surgery until discharge, an average of 3 to 4 days.
description: Will measure pain using visual analog scale.
measure: Foot Drop
time frame: Evaluated in the first 24, 48, 72 hours prior to discharge.
description: Daily lower extremity neurological examination of the foot (specifically dorsiflexion.
measure: Patient Satisfaction
time frame: Evaluated every 24, 48 and 72 hours prior to discharge.
description: Patient satisfaction assessed using a daily numeric scale form (1-5 with 5 being most satisfied).
measure: Opioid Consumption
time frame: Evaluated every 24, 48, 72 hours prior to discharge.
description: Compare the total consumption of opioid use in study patients compared to control patients.
arm group label: Continuous femoral and single shot sciatic nerve block
arm group type: Active Comparator
description: Will receive pre-operative continuous femoral catheter & post-operative single shot sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine & 20mL (sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which will be running Ropivicaine 0.2 at 10cc/hr.
arm group label: Continuous femoral and tibial peripheral nerve catheters
arm group type: Experimental
description: Patients will receive pre-operative continuous femoral catheter & post-operative continuous tibial catheter with an initial bolus of 30 mL 0.5% Ropivicaine (femoral) & 20mL 0.2% Ropivicaine (tibial), which will be followed by infusions post-operatively running at 10cc/hr.
intervention type: Drug
intervention name: Ropivicaine
description: Infusion of local anesthetic for post-operative analgesia.
arm group label: Continuous femoral and single shot sciatic nerve block
arm group label: Continuous femoral and tibial peripheral nerve catheters
intervention type: Device
intervention name: Continuous Femoral Nerve Catheter
description: Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.
arm group label: Continuous femoral and single shot sciatic nerve block
arm group label: Continuous femoral and tibial peripheral nerve catheters
other name: Continous femoral nerve catheter infusion
intervention type: Device
intervention name: Continuous Tibial Nerve Catheter
description: Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.
arm group label: Continuous femoral and tibial peripheral nerve catheters
other name: Continuous tibial nerve catheter infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hana Teissler, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
last name: John Zaki, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center- Paul L. Foster School of Medicine of El Paso
facility: 
country: United States
url: http://elpaso.ttuhsc.edu/som/anesthesiology/
description: Related Info
responsible party type: Sponsor