<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/NCT03752957</url>
  </required_header>
  <id_info>
    <org_study_id>WideAwake Flexor Tendon Repair</org_study_id>
    <nct_id>NCT03752957</nct_id>
  </id_info>
  <brief_title>Wide-Awake Local Anesthesia For Flexor Tendon Repair</brief_title>
  <official_title>Wide-Awake Local Anesthesia No Tourniquet Versus. Local/General Anesthesia for Flexor Tendon Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      Primary repair for flexor tendon lacerations remain the standard of care. However, despite&#xD;
      recent advances in knowledge of tendon healing, suture material, and post-operative&#xD;
      protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications&#xD;
      encountered include adhesion formation, development of joint contractures, tendon rupture,&#xD;
      triggering, bow stringing and quadriplegia. Tendon surgery is unique because it should ensure&#xD;
      tendon gliding after surgery Tendon surgery now can be performed under local anesthesia&#xD;
      without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve&#xD;
      vasoconstriction in the area of surgery. This method allows the tendon to move actively&#xD;
      during surgery to test tendon function intraoperatively and to ensure the tendon is properly&#xD;
      repaired before leaving the operating table.&#xD;
&#xD;
      Wide awake hand surgery is well described by its other name, WALANT which stands for wide&#xD;
      awake local anaesthesia no tourniquet. The only two medications most patients are given for&#xD;
      wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the&#xD;
      period before 1950, the belief developed among surgeons that epinephrine causes finger&#xD;
      necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine). It&#xD;
      was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948.&#xD;
      More fingers died from procaine injection alone than from procaine plus epinephrine injection&#xD;
      .no lost finger no case require phentolamine in many studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary repair for flexor tendon lacerations remain the standard of care. However, despite&#xD;
      recent advances in knowledge of tendon healing, suture material, and post-operative&#xD;
      protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications&#xD;
      encountered include adhesion formation, development of joint contractures, tendon rupture,&#xD;
      triggering, bowstringing and quadrigia. Tendon surgery is unique because it should ensure&#xD;
      tendon gliding after surgery It has been a standard practice to obtain local or general&#xD;
      anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been&#xD;
      changed in recent years...&#xD;
&#xD;
      Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting&#xD;
      epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This&#xD;
      method allows the tendon to move actively during surgery to test tendon function&#xD;
      intraoperatively and to ensure the tendon is properly repaired before leaving the operating&#xD;
      table.&#xD;
&#xD;
      The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active&#xD;
      fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures,&#xD;
      revise pulley reconstruction, or de-bulk tendons before wound closure Wide awake hand surgery&#xD;
      is well described by its other name, WALANT which stands for wide awake local anaesthesia no&#xD;
      tourniquet. The only two medications most patients are given for wide awake hand surgery are&#xD;
      Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the&#xD;
      belief developed among surgeons that epinephrine causes finger necrosis .The source of the&#xD;
      epinephrine myth stemmed from the use of procaine (Novocaine).8 It was the only safely&#xD;
      injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died&#xD;
      from procaine injection alone than from procaine plus epinephrine injection .no lost finger&#xD;
      no case require phentolamine in many studies.The &quot;smoking gun&quot; paper that established that&#xD;
      procaine was the actual cause of finger deaths published in the Journal of the American&#xD;
      Medical Association that found batches of procaine with a pH of 1 destined for injection into&#xD;
      humans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>post operative complication rate</measure>
    <time_frame>average 2 months</time_frame>
    <description>Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Flexor Tendon Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Assiut University Hospital , microsurgery unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over the age of 18 acute single or multiple digit complete flexor tendon lacerations&#xD;
             in zones I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gross wound contamination&#xD;
&#xD;
          -  segmental tendon loss&#xD;
&#xD;
          -  associated finger fractures&#xD;
&#xD;
          -  complex or multisystem injuries&#xD;
&#xD;
          -  complex or multisystem injuries&#xD;
&#xD;
          -  mangled hand injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tarek Abdula ELgamal</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amr Elsaid Ali</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Mostafa Kotb</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Salah Eldin Koriem</last_name>
    <phone>+201002766810</phone>
    <email>Mohamed.elshreef.mes@gmail.com</email>
  </overall_contact>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Slah Eldin Koriem</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <keyword>Wide-Awake Local Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendon Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03752957
org study id: WideAwake Flexor Tendon Repair
nct id: NCT03752957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Primary repair for flexor tendon lacerations remain the standard of care. However, despite
      recent advances in knowledge of tendon healing, suture material, and post-operative
      protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications
      encountered include adhesion formation, development of joint contractures, tendon rupture,
      triggering, bow stringing and quadriplegia. Tendon surgery is unique because it should ensure
      tendon gliding after surgery Tendon surgery now can be performed under local anesthesia
      without tourniquet, by injecting epinephrine mixed with lidocaine, to achieve
      vasoconstriction in the area of surgery. This method allows the tendon to move actively
      during surgery to test tendon function intraoperatively and to ensure the tendon is properly
      repaired before leaving the operating table.

      Wide awake hand surgery is well described by its other name, WALANT which stands for wide
      awake local anaesthesia no tourniquet. The only two medications most patients are given for
      wide awake hand surgery are Lidocaine for anaesthesia and epinephrine for haemostasis. In the
      period before 1950, the belief developed among surgeons that epinephrine causes finger
      necrosis .The source of the epinephrine myth stemmed from the use of procaine (Novocaine). It
      was the only safely injectable local anaesthetic until the introduction of Lidocaine in 1948.
      More fingers died from procaine injection alone than from procaine plus epinephrine injection
      .no lost finger no case require phentolamine in many studies.
Primary repair for flexor tendon lacerations remain the standard of care. However, despite
      recent advances in knowledge of tendon healing, suture material, and post-operative
      protocols, outcomes have been reported as fair or poor in 7-20% of patients. Complications
      encountered include adhesion formation, development of joint contractures, tendon rupture,
      triggering, bowstringing and quadrigia. Tendon surgery is unique because it should ensure
      tendon gliding after surgery It has been a standard practice to obtain local or general
      anesthesia and apply a tourniquet to perform tendon surgery. However, this practice has been
      changed in recent years...

      Tendon surgery now can be performed under local anesthesia without tourniquet, by injecting
      epinephrine mixed with lidocaine, to achieve vasoconstriction in the area of surgery. This
      method allows the tendon to move actively during surgery to test tendon function
      intraoperatively and to ensure the tendon is properly repaired before leaving the operating
      table.

      The surgeon can inspect for bunching, gapping, and triggering of the repair site in an active
      fashion. Thus, an opportunity is available to revise the repair, trim or add extra sutures,
      revise pulley reconstruction, or de-bulk tendons before wound closure Wide awake hand surgery
      is well described by its other name, WALANT which stands for wide awake local anaesthesia no
      tourniquet. The only two medications most patients are given for wide awake hand surgery are
      Lidocaine for anaesthesia and epinephrine for haemostasis. In the period before 1950, the
      belief developed among surgeons that epinephrine causes finger necrosis .The source of the
      epinephrine myth stemmed from the use of procaine (Novocaine).8 It was the only safely
      injectable local anaesthetic until the introduction of Lidocaine in 1948. More fingers died
      from procaine injection alone than from procaine plus epinephrine injection .no lost finger
      no case require phentolamine in many studies.The "smoking gun" paper that established that
      procaine was the actual cause of finger deaths published in the Journal of the American
      Medical Association that found batches of procaine with a pH of 1 destined for injection into
      humans.
observational model: Cohort
time perspective: Prospective
measure: post operative complication rate
time frame: average 2 months
description: Infection requiring antibiotics, tendon rupture, stiffness or contracture requiring tenolysis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tarek Abdula ELgamal
role: Study Chair
affiliation: Assiut University
last name: Amr Elsaid Ali
role: Study Chair
affiliation: Assiut University
last name: Mohamed Mostafa Kotb
role: Study Director
affiliation: Assiut University
last name: Mohamed Salah Eldin Koriem
phone: +201002766810
email: Mohamed.elshreef.mes@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Slah Eldin Koriem
investigator title: Assistant Lecturer
mesh term: Tendon Injuries
sharing ipd: No