<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/NCT02986347</url>
  </required_header>
  <id_info>
    <org_study_id>HAMAO01</org_study_id>
    <nct_id>NCT02986347</nct_id>
  </id_info>
  <brief_title>Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia.</brief_title>
  <official_title>Surgical Treatment of Carpal Tunnel Syndrome: Local Anesthesia With Epinephrine x Intravenous Regional Anesthesia. Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Alvorada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Alvorada</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>
      The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In&#xD;
      the last decade some studies have described the performance of this surgery using local&#xD;
      anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote,&#xD;
      having good effectiveness and substantial reduction of costs. However there is need for&#xD;
      studies with an appropriate design and methodology to evaluate the actual effectiveness of&#xD;
      this kind of anesthesia for the surgical treatment of CTS.&#xD;
&#xD;
      Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized&#xD;
      trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local&#xD;
      anesthesia with adrenaline without limb garroting (Lalondi).&#xD;
&#xD;
      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of&#xD;
      Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with&#xD;
      co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This&#xD;
      study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in&#xD;
      78 patients. The following primary outcomes will be assessed: Pain through visual analogue&#xD;
      scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The&#xD;
      secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS&#xD;
      (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal&#xD;
      Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention,&#xD;
      complications and failures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical treatment of CTS is most often performed under hospital conditions, with the use of&#xD;
      anesthesia. The anesthetic technique of choice varies among surgeons. In the last decade some&#xD;
      studies have described the performance of this surgery using local anesthesia with adrenaline&#xD;
      without the necessity of sedation or the use of pneumatic garrote, having good effectiveness&#xD;
      and substantial reduction of costs for the procedure with this anesthetic method. However,&#xD;
      when we evaluated the level and strength of the evidence from these studies, we notice that&#xD;
      there is a need for studies with an appropriate design and methodology to evaluate the actual&#xD;
      effectiveness of this kind of anesthesia for the surgical treatment of CTS.&#xD;
&#xD;
      Objective: To evaluate the effectiveness of open surgery for CTS in a randomized trial&#xD;
      comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local anesthesia&#xD;
      with adrenaline without limb garroting (Lalondi).&#xD;
&#xD;
      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of&#xD;
      Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with&#xD;
      co-participation of the Hand Surgery and Microsurgery Department of the Medical Residency&#xD;
      Service in Hand Surgery of Hospital Alvorada. This study will be a Randomized Clinical Trial.&#xD;
      The previous calculation of the sample resulted in the need for total inclusion of 35&#xD;
      patients in each group, total of 70 patients, considering a loss of 10% during follow-up we&#xD;
      will include 78 patients. The following primary outcomes will be assessed: Pain through&#xD;
      visual analogue scale (VAS), that, will be measured in the pre-operative, transoperatory,&#xD;
      immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after surgery. Costs:&#xD;
      Costs related to anesthetic and surgical procedures will be recorded. The secondary outcomes&#xD;
      will be: Use of Analgesics, Anxiety and Depression through the HADS (Hospital Anxiety and&#xD;
      Depression Scale) scale. Quality of life through the Boston Carpal Tunnel Syndrome&#xD;
      Questionnaire (BCTQ). Remission of paresthesia after surgical intervention, complications and&#xD;
      failures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2017</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain through Pain visual analogue scale</measure>
    <time_frame>Before the treatment and after the treatment (intraoperative and after the treatment:immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after the end of surgery.</time_frame>
    <description>Pain measurement through visual analog scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The total costs of carpal tunnel syndrome surgical treatment will be tracked over the duration of the study to determine the cost-effectiveness of providing a Local Anesthesia With Epinephrine versus a Intravenous Regional Anesthesia.</measure>
    <time_frame>3 months</time_frame>
    <description>The following costs related to anesthetic and surgical procedures will be computed:&#xD;
consumer material used in the anesthetic and surgical procedure&#xD;
medical and paramedical staff&#xD;
time of use of the surgical rooms for postoperative recovery&#xD;
length of hospital stay&#xD;
medicines used up to one postoperative week&#xD;
necessary costs for the treatment of possible complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Boston Carpal Tunnel Questionnaire (BCTQ)</measure>
    <time_frame>preoperatively and 12 weeks post-operation</time_frame>
    <description>Patients in the study group will respond to Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) translated and validated for Portuguese preoperative (after initial clinical evaluation) and postoperative (3th month PO). It is a disease specific questionnaire, self-administered, and evaluates the severity of the symptoms and functional status of patients with CTS. The BCTQ assesses the symptoms and the severity, frequency, time and type. The functional degree of scale evaluates how the syndrome affects daily life. Issues relating to the severity scale are composed of 11 questions. Each question has five answers, placed in order of increasing severity of symptoms. The issues relating to the functional status are composed of 8 questions, each of which corresponds to a functional activity. Each activity has a 5-degree-answer of difficulty progressively worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>preoperatively and 12 weeks post-operation</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission or not of paresthesia until the third month</measure>
    <time_frame>preoperatively and 12 weeks post-operation</time_frame>
    <description>The absence of paresthesia reported by the patient after surgery will be considered as &quot;cure&quot;. The not regression paresthesia referred by patients in this period will be considered as non-healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Record and evaluate all complications associated with the surgical procedure</measure>
    <time_frame>12 weeks post-operation</time_frame>
    <description>Complications rate of surgical and anesthesic procedures in patients with CTS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Intravenous regional anesthesia (Bier)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The anesthetic technique described by Bier will be done by the anesthesiologist. The following steps were followed: 1)Placement double tourniquet on the proximal portion of the arm 2)Asepsis and antisepsis of the operative limb 3)Puncture and venous catheterization most distal in the limb 4)Elevation of limb for 1 to 2 minutes, next the limb will be spirally wrapped with Esmarch from the distal to proximal 5)The proximal cuff will be inflated 6)Withdrawal of Esmarch and injection of 40ml of lidocaine without epinephrine at 0.5% 7)Removal the canula until the distal cuff is inflated and the proximal cuff is emptied 8)Removal of the club must be done after the surgery, at least 40 minutes after the injection of the anesthetic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anesthesia with adrenaline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be anesthetized by surgeons, who are familiar with the technique described by Lalonde. Around thirty minutes before surgery, will be infused with 20 ml of an anesthetic solution. The infiltrated solution is composed of 1% lidocaine with epinephrine in 1: 100,000. Initially 10 mL of the solution will be applied slowly in the flexion fold region of the wrist just below the skin and subfascial plane. The needle is moved slowly. The needle is then redirected to the radial side of the proximal palmar region for infiltration of another 2-3 mL of the subcutaneous solution. The remaining 7-8mL in the subdermal plane and anterior to the transverse carpal ligament.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intravenous regional anesthesia (Bier)</intervention_name>
    <description>Intravenous regional anesthesia (Bier Technique)</description>
    <arm_group_label>Intravenous regional anesthesia (Bier)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local anesthesia with adrenaline</intervention_name>
    <description>local anesthesia with adrenaline without limber garroting (Lalonde Technique)</description>
    <arm_group_label>Local anesthesia with adrenaline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years of age, with idiopathic Carpal Tunnel Syndrome with&#xD;
             indication for surgery due to failure of conservative treatment for at least three&#xD;
             months or that presented at the initial diagnosis with motor impairment detected by&#xD;
             clinical examination (hypotrophy) and/or by electromyography (ENMG) examination.&#xD;
&#xD;
          -  The diagnosis of CTS will be made through the clinical evaluation in which CTS&#xD;
             patients will be considered, those who present at least four of the clinical criteria&#xD;
             proposed and proven by the electromyography examination.&#xD;
&#xD;
        Clinical Criteria for CTS - (At least 4 criteria will be required for clinical confirmation&#xD;
        of the diagnosis)&#xD;
&#xD;
          1. Paresthesia in the territory of the median nerve&#xD;
&#xD;
          2. Night paresthesia of the hand&#xD;
&#xD;
          3. Decreased strength with hypotrophy of the musculature tenar&#xD;
&#xD;
          4. Positive tinnitus sign on the wrist&#xD;
&#xD;
          5. Positive Phalen test&#xD;
&#xD;
          6. Loss of 2-point discrimination in the region innervated by the median nerve&#xD;
&#xD;
               -  Patients who agree to participate, after having been adequately informed about&#xD;
                  the nature of the study, and have reading and signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior history of cervical spine diseases (radiculopathies, arthrosis),&#xD;
&#xD;
          -  Pregnant women and puerperal women,&#xD;
&#xD;
          -  Patients with sequelae of previous wrist and hand surgeries,&#xD;
&#xD;
          -  Other upper limb compressive syndromes and scapular girdles will be excluded&#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>Aldo Okamura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Alvorada de Moema</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aldo Okamura</name>
      <address>
        <city>São Paulo</city>
        <zip>03325000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Mckee DE, Lalonde DH, Thoma A, Dickson L. Achieving the optimal epinephrine effect in wide awake hand surgery using local anesthesia without a tourniquet. Hand (N Y). 2015 Dec;10(4):613-5. doi: 10.1007/s11552-015-9759-6. Epub 2015 Apr 14.</citation>
    <PMID>26568713</PMID>
  </reference>
  <reference>
    <citation>Davison PG, Cobb T, Lalonde DH. The patient's perspective on carpal tunnel surgery related to the type of anesthesia: a prospective cohort study. Hand (N Y). 2013 Mar;8(1):47-53. doi: 10.1007/s11552-012-9474-5.</citation>
    <PMID>24426892</PMID>
  </reference>
  <reference>
    <citation>Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.</citation>
    <PMID>16182068</PMID>
  </reference>
  <reference>
    <citation>Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.</citation>
    <PMID>8245050</PMID>
  </reference>
  <reference>
    <citation>Leblanc MR, Lalonde J, Lalonde DH. A detailed cost and efficiency analysis of performing carpal tunnel surgery in the main operating room versus the ambulatory setting in Canada. Hand (N Y). 2007 Dec;2(4):173-8. doi: 10.1007/s11552-007-9043-5. Epub 2007 May 30.</citation>
    <PMID>18780048</PMID>
  </reference>
  <reference>
    <citation>Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.</citation>
    <PMID>6880820</PMID>
  </reference>
  <reference>
    <citation>Robles DS, Esteves S, Liça M, Lopes D, Lima S, Sousa C. Tratamento da síndrome do túnel cárpico:anestesia geral versus local?. Rev Port Ortop e Traum 23(3):217-224, 2015.</citation>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>April 13, 2020</last_update_submitted>
  <last_update_submitted_qc>April 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Alvorada</investigator_affiliation>
    <investigator_full_name>João Carlos Belloti</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_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/NCT02986347
org study id: HAMAO01
nct id: NCT02986347
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The anesthetic technique of choice for surgical treatment of CTS varies among surgeons. In
      the last decade some studies have described the performance of this surgery using local
      anesthesia with adrenaline without the necessity of sedation or the use of pneumatic garrote,
      having good effectiveness and substantial reduction of costs. However there is need for
      studies with an appropriate design and methodology to evaluate the actual effectiveness of
      this kind of anesthesia for the surgical treatment of CTS.

      Objective: To evaluate the effectiveness and cost of open surgery for CTS in a randomized
      trial comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local
      anesthesia with adrenaline without limb garroting (Lalondi).

      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of
      Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with
      co-participation of the Hand Surgery and Microsurgery Department of Hospital Alvorada. This
      study will be a Randomized Clinical Trial. The previous calculation of the sample resulted in
      78 patients. The following primary outcomes will be assessed: Pain through visual analogue
      scale (VAS). Costs: Costs related to anesthetic and surgical procedures will be recorded. The
      secondary outcomes will be: Use of Analgesics, Anxiety and Depression through the HADS
      (Hospital Anxiety and Depression Scale) scale. Quality of life through the Boston Carpal
      Tunnel Syndrome Questionnaire (BCTQ). Remission of paresthesia after surgical intervention,
      complications and failures.
Surgical treatment of CTS is most often performed under hospital conditions, with the use of
      anesthesia. The anesthetic technique of choice varies among surgeons. In the last decade some
      studies have described the performance of this surgery using local anesthesia with adrenaline
      without the necessity of sedation or the use of pneumatic garrote, having good effectiveness
      and substantial reduction of costs for the procedure with this anesthetic method. However,
      when we evaluated the level and strength of the evidence from these studies, we notice that
      there is a need for studies with an appropriate design and methodology to evaluate the actual
      effectiveness of this kind of anesthesia for the surgical treatment of CTS.

      Objective: To evaluate the effectiveness of open surgery for CTS in a randomized trial
      comparing two anesthesia methods: intravenous regional anesthesia (Bier) and local anesthesia
      with adrenaline without limb garroting (Lalondi).

      Methods: This study was developed in the Group of Hand Surgery and Upper Limb; Department of
      Orthopedics and Traumatology, Federal University of São Paulo, UNIFESP / EPM with
      co-participation of the Hand Surgery and Microsurgery Department of the Medical Residency
      Service in Hand Surgery of Hospital Alvorada. This study will be a Randomized Clinical Trial.
      The previous calculation of the sample resulted in the need for total inclusion of 35
      patients in each group, total of 70 patients, considering a loss of 10% during follow-up we
      will include 78 patients. The following primary outcomes will be assessed: Pain through
      visual analogue scale (VAS), that, will be measured in the pre-operative, transoperatory,
      immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after surgery. Costs:
      Costs related to anesthetic and surgical procedures will be recorded. The secondary outcomes
      will be: Use of Analgesics, Anxiety and Depression through the HADS (Hospital Anxiety and
      Depression Scale) scale. Quality of life through the Boston Carpal Tunnel Syndrome
      Questionnaire (BCTQ). Remission of paresthesia after surgical intervention, complications and
      failures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: open label
measure: Change in pain through Pain visual analogue scale
time frame: Before the treatment and after the treatment (intraoperative and after the treatment:immediate postoperative, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours after the end of surgery.
description: Pain measurement through visual analog scale
measure: The total costs of carpal tunnel syndrome surgical treatment will be tracked over the duration of the study to determine the cost-effectiveness of providing a Local Anesthesia With Epinephrine versus a Intravenous Regional Anesthesia.
time frame: 3 months
description: The following costs related to anesthetic and surgical procedures will be computed:
consumer material used in the anesthetic and surgical procedure
medical and paramedical staff
time of use of the surgical rooms for postoperative recovery
length of hospital stay
medicines used up to one postoperative week
necessary costs for the treatment of possible complications
measure: Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
time frame: preoperatively and 12 weeks post-operation
description: Patients in the study group will respond to Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) translated and validated for Portuguese preoperative (after initial clinical evaluation) and postoperative (3th month PO). It is a disease specific questionnaire, self-administered, and evaluates the severity of the symptoms and functional status of patients with CTS. The BCTQ assesses the symptoms and the severity, frequency, time and type. The functional degree of scale evaluates how the syndrome affects daily life. Issues relating to the severity scale are composed of 11 questions. Each question has five answers, placed in order of increasing severity of symptoms. The issues relating to the functional status are composed of 8 questions, each of which corresponds to a functional activity. Each activity has a 5-degree-answer of difficulty progressively worsening.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: preoperatively and 12 weeks post-operation
description: Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
measure: Remission or not of paresthesia until the third month
time frame: preoperatively and 12 weeks post-operation
description: The absence of paresthesia reported by the patient after surgery will be considered as "cure". The not regression paresthesia referred by patients in this period will be considered as non-healing.
measure: Record and evaluate all complications associated with the surgical procedure
time frame: 12 weeks post-operation
description: Complications rate of surgical and anesthesic procedures in patients with CTS
arm group label: Intravenous regional anesthesia (Bier)
arm group type: Active Comparator
description: The anesthetic technique described by Bier will be done by the anesthesiologist. The following steps were followed: 1)Placement double tourniquet on the proximal portion of the arm 2)Asepsis and antisepsis of the operative limb 3)Puncture and venous catheterization most distal in the limb 4)Elevation of limb for 1 to 2 minutes, next the limb will be spirally wrapped with Esmarch from the distal to proximal 5)The proximal cuff will be inflated 6)Withdrawal of Esmarch and injection of 40ml of lidocaine without epinephrine at 0.5% 7)Removal the canula until the distal cuff is inflated and the proximal cuff is emptied 8)Removal of the club must be done after the surgery, at least 40 minutes after the injection of the anesthetic.
arm group label: Local anesthesia with adrenaline
arm group type: Active Comparator
description: Patients will be anesthetized by surgeons, who are familiar with the technique described by Lalonde. Around thirty minutes before surgery, will be infused with 20 ml of an anesthetic solution. The infiltrated solution is composed of 1% lidocaine with epinephrine in 1: 100,000. Initially 10 mL of the solution will be applied slowly in the flexion fold region of the wrist just below the skin and subfascial plane. The needle is moved slowly. The needle is then redirected to the radial side of the proximal palmar region for infiltration of another 2-3 mL of the subcutaneous solution. The remaining 7-8mL in the subdermal plane and anterior to the transverse carpal ligament.
intervention type: Procedure
intervention name: Intravenous regional anesthesia (Bier)
description: Intravenous regional anesthesia (Bier Technique)
arm group label: Intravenous regional anesthesia (Bier)
intervention type: Procedure
intervention name: Local anesthesia with adrenaline
description: local anesthesia with adrenaline without limber garroting (Lalonde Technique)
arm group label: Local anesthesia with adrenaline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aldo Okamura, MD
role: Principal Investigator
affiliation: Hospital Alvorada de Moema
facility: 
country: Brazil
citation: Mckee DE, Lalonde DH, Thoma A, Dickson L. Achieving the optimal epinephrine effect in wide awake hand surgery using local anesthesia without a tourniquet. Hand (N Y). 2015 Dec;10(4):613-5. doi: 10.1007/s11552-015-9759-6. Epub 2015 Apr 14.
PMID: 26568713
citation: Davison PG, Cobb T, Lalonde DH. The patient's perspective on carpal tunnel surgery related to the type of anesthesia: a prospective cohort study. Hand (N Y). 2013 Mar;8(1):47-53. doi: 10.1007/s11552-012-9474-5.
PMID: 24426892
citation: Lalonde D, Bell M, Benoit P, Sparkes G, Denkler K, Chang P. A multicenter prospective study of 3,110 consecutive cases of elective epinephrine use in the fingers and hand: the Dalhousie Project clinical phase. J Hand Surg Am. 2005 Sep;30(5):1061-7. doi: 10.1016/j.jhsa.2005.05.006.
PMID: 16182068
citation: Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
PMID: 8245050
citation: Leblanc MR, Lalonde J, Lalonde DH. A detailed cost and efficiency analysis of performing carpal tunnel surgery in the main operating room versus the ambulatory setting in Canada. Hand (N Y). 2007 Dec;2(4):173-8. doi: 10.1007/s11552-007-9043-5. Epub 2007 May 30.
PMID: 18780048
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PMID: 6880820
citation: Robles DS, Esteves S, Liça M, Lopes D, Lima S, Sousa C. Tratamento da síndrome do túnel cárpico:anestesia geral versus local?. Rev Port Ortop e Traum 23(3):217-224, 2015.
responsible party type: Principal Investigator
investigator affiliation: Hospital Alvorada
investigator full name: João Carlos Belloti
investigator title: PhD
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Anesthetics
mesh term: Epinephryl borate
sharing ipd: No