<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/NCT03761329</url>
  </required_header>
  <id_info>
    <org_study_id>18.46/ANESTH18.03</org_study_id>
    <nct_id>NCT03761329</nct_id>
  </id_info>
  <brief_title>Bier's Block Versus Mini-bier's Block in Patients Undergoing Hand Surgery</brief_title>
  <official_title>A Randomized Controlled Trial to Investigate the Efficacy of a Bier's Block Compared to a Mini-bier's Block in Patients Undergoing Hand Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jessa Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jessa Hospital</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>
      By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of an&#xD;
      upper-arm Bier's block and a forearm mini-Bier's block will be investigated in patients&#xD;
      undergoing hand surgery. The hypothesis is that there is no difference between the two types&#xD;
      of anesthetic techniques with respect to the analgesic efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Several ways of anesthesia can be used to perform hand surgery, being general anesthesia,&#xD;
      intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia&#xD;
      and intravenous regional anesthesia are often performed since patients can be discharged from&#xD;
      the hospital more rapidly.&#xD;
&#xD;
      A conventional Bier's block is performed using a tourniquet on the upper arm to create a&#xD;
      bloodless field and to contain the anesthetics within the surgical area (1). Complications&#xD;
      are rare but are often linked to a systemic toxicity reaction after releasing the tourniquet&#xD;
      (2). A mini-Bier's block in which the tourniquet is placed on the fore-arm, has been shown to&#xD;
      be a safe and effective way of anesthesia to perform hand surgery. By using this type of&#xD;
      anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block&#xD;
      which reduces the risk of systemic toxicity reactions (3-5).&#xD;
&#xD;
      Currently, studies that made a comparison between the two anesthesia techniques are scarce&#xD;
      and inconsistent. Next to that, those studies also used different types of anesthetics and&#xD;
      dosages. To see which technique is advantageous in clinical practice, the investigators want&#xD;
      to investigate the efficacy of the Bier's block and mini-Bier's block in patients that are&#xD;
      planned to undergo hand surgery.&#xD;
&#xD;
      Outcome measures:&#xD;
&#xD;
      The primary aim of this study is to compare the analgesic efficacy of the Bier's block versus&#xD;
      the mini-Bier's block. The hypothesis is that there is no difference between the two&#xD;
      techniques. A blinded surgeon will determine the analgesic efficacy of these techniques&#xD;
      (graded as &quot;complete&quot; or &quot;incomplete&quot;) and divide the efficacy in 4 grades. Grade 1 and grade&#xD;
      2 are considered &quot;complete&quot; blockade, while grade 3 and grade 4 are considered &quot;incomplete&quot;&#xD;
      blockade. Grade 1: complete motor and sensory blockade, grade 2: partial motor blockade but&#xD;
      no pain or deep pressure sensitivity, grade 3: partial motor blockade with mild pain&#xD;
      requiring rescue local or opioid analgesia, grade 4: incomplete motor- and sensory blockade&#xD;
      requiring sedation/conversion to general anesthesia).&#xD;
&#xD;
      Secondary study outcomes:&#xD;
&#xD;
        -  Onset time, which is defined as the time from the injection of the local anesthetic&#xD;
           until the complete sensory loss in hand (assessed by the blinded surgeon via &quot;pin&#xD;
           prick&quot;).&#xD;
&#xD;
        -  Patient's pre-, intra- and post-operative pain scores will be measured via an 11-point&#xD;
           Numeric Rating Scale (NRS) in which number 0 means &quot;no pain at all&quot;, number 5 means&#xD;
           &quot;moderate pain&quot; and number 10 means &quot;worst possible pain&quot;.&#xD;
&#xD;
        -  Tourniquet time: the amount of time that the tourniquet is inflated.&#xD;
&#xD;
        -  Tourniquet tolerance time: the amount of time required for the inflated tourniquet to&#xD;
           cause a painful sensation (NRS &gt; 3).&#xD;
&#xD;
        -  Satisfaction with the surgical field (bloodless field) will be graded by a blinded&#xD;
           surgeon, measured using a 5-point scale (1= extremely dissatisfied until 5= extremely&#xD;
           satisfied).&#xD;
&#xD;
        -  The time spent in the operating room.&#xD;
&#xD;
        -  Duration of surgery.&#xD;
&#xD;
        -  General patient satisfaction will be assessed using a 7-point Likert Scale, in which&#xD;
           number 1 equals &quot;extremely dissatisfied&quot; and number 7 means &quot;extremely satisfied&quot;.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      In this monocentric, investigator-initiated, observer-blinded, prospective, randomized,&#xD;
      controlled, non-inferiority trial, 2 anaesthetic procedures will be compared in patients that&#xD;
      undergo hand surgery (Carpal Tunnel Syndrome, trigger finger, dequervain tenovaginitis,&#xD;
      disease of Dupuytren, ganglion cyst).&#xD;
&#xD;
      This study will be performed according to the Declaration of Helsinki and will be approved by&#xD;
      the ethics committee of the JESSA Hospital, Hasselt, Belgium before the start of the study. A&#xD;
      written informed consent will be obtained before participation in the study.&#xD;
&#xD;
      Randomization will be performed using a computer-generated random allocation sequence.&#xD;
      Allocation numbers will be sealed in opaque envelopes, which will be opened in sequence by an&#xD;
      independent anesthesiologist who is not involved in the assessment of outcomes.&#xD;
&#xD;
      Both the surgeon and the researcher will be blinded for the used type of anesthesia. Since&#xD;
      the clear difference between an upper arm and forearm tourniquet, all patients will receive a&#xD;
      second tourniquet which will not be inflated. That is, patients receiving the Bier's block&#xD;
      will receive an additional forearm tourniquet which will not be inflated and patients in&#xD;
      group of the mini-Bier's block will receive an additional upperarm tourniquet which will not&#xD;
      be inflated. In this way, a possible de-blinding of the surgeon and researcher is minimized.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
      The patient will first receive information about this study. Before the start of the study,&#xD;
      written informed consent will be obtained, after which the patient will be randomized to one&#xD;
      of the 2 treatment groups. Before surgery, all patients will receive an intravenous catheter&#xD;
      in the contralateral arm with infusion of 0.9% Natriumchloride (NaCl), paracetamol 1g and&#xD;
      standard monitoring (non-invasive blood pressure, electrocardiogram and O2 saturation&#xD;
      measurements).&#xD;
&#xD;
      In the Bier's block group:&#xD;
&#xD;
      An intravenous catheter will be placed in the dorsal vein of the hand that will undergo&#xD;
      surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which&#xD;
      the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The&#xD;
      tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions&#xD;
      postoperatively.&#xD;
&#xD;
      In the mini-Bier's block group:&#xD;
&#xD;
      An intravenous catheter will be placed in the dorsal vein of the hand that will undergo&#xD;
      surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the&#xD;
      anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The&#xD;
      tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions&#xD;
      postoperatively.&#xD;
&#xD;
      Before the start of the surgery, the blinded surgeon will assess the quality of the block&#xD;
      (primary outcome) using a forceps. The quality of the block will be graded &quot;complete&quot; or&#xD;
      &quot;incomplete&quot; as described above. In case of grade 1 or grade 2, the surgical procedure can&#xD;
      start. In case of grade 3, the blockade will be enhanced (local anesthetic or intravenous&#xD;
      opioid administration (alfentanil or sufentanil)). In case of grade 4, sedation/conversion to&#xD;
      general anesthesia will be performed.&#xD;
&#xD;
      All secondary outcome measures will be investigated by the blinded researcher.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Sample size was determined for the primary study outcome with the aim to reject the&#xD;
      non-inferiority of the mini-Bier's block. Based on a meta-analysis (unpublished data) we&#xD;
      expect a 98.5% complete blockade in the experimental group (mini-Bier's block) and a 100%&#xD;
      complete blockade in the control group (Bier's block). With a difference of 5% between the 2&#xD;
      groups and a binary outcome (complete/incomplete), we calculated that 135 patients are needed&#xD;
      per group (α=0.05, power=0.80). Considering a drop-out rate of 3.5%, the total number of&#xD;
      patients is 140 per group.&#xD;
&#xD;
      Descriptive statistics will be presented as frequencies and percentages of the total amount&#xD;
      of patients for categorical variables, while numerical variables will be presented as mean.&#xD;
      Group comparison will be performed using Chi-square test (or a Fisher's Exact test when&#xD;
      necessary) for frequencies. Depending on normality, a Mann-Whitney U test or a Student's&#xD;
      t-test will be used. Corrections will be applied for multiple measurements of the Numerical&#xD;
      Rating Scale (NRS) for pain scores. An average difference of 1.3 points or more on the NRS&#xD;
      pain score is considered clinical relevant. A p-value &lt;0.05 is considered statistical&#xD;
      significant, while p&lt;0.10 is considered a tendency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">March 20, 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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensory and motor block of the hand</measure>
    <time_frame>5 minutes after injection of lidocaine 0.5%</time_frame>
    <description>This study wants to evaluate and compare the analgesic efficacy of the Bier's block with the mini-Bier's block. The blinded surgeon will assess the analgesic effectivity and grade it as either complete (grade 1 and grade 2) or incomplete (grade 3 and grade 4). Grade 1 is defined as complete motor and sensory blockade; grade 2 is defined as partial motor blockade with no pain or deep pressure sensitivity. Grade 3 is defined as partial motor blockade with mild pain and the need for rescue local or opioid analgesia. Grade 4 is defined as incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-operative pain score: Numeric Rating Scale (NRS)</measure>
    <time_frame>Before the start of anesthesia technique</time_frame>
    <description>Pain score before the start of anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain due to anesthesia technique: Numeric Rating Scale (NRS)</measure>
    <time_frame>At the end of performing the anesthesia technique</time_frame>
    <description>Pain caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tourniquet time</measure>
    <time_frame>From start of inflation until deflation of the tourniquet</time_frame>
    <description>Total time the tourniquet is inflated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset time of analgesia</measure>
    <time_frame>At injection of the anaesthetic until complete blockade of the sensory nerves</time_frame>
    <description>Onset time of analgesia (starts at injection of the anaesthetic and will continue until complete blockade of the sensory nerves (assessed via pin prick)). When after 10 minutes no sensory blockade occurred, rescue medication (alfentanil (0,5 mg)) will be applied. When alfentanil (0,5 mg) will not provide enough sensory blockade, sedation with diprivan (titration per 1cc) or, if required, conversion to general anesthesia will be applied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tourniquet tolerance time</measure>
    <time_frame>From start of inflation until deflation of the tourniquet</time_frame>
    <description>Time required for the tourniquet to cause a painful sensation (NRS &gt; 3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score at start of surgery (surgical incision): Numeric Rating Scale (NRS)</measure>
    <time_frame>At the start of the surgical procedure</time_frame>
    <description>Pain score at surgical incision (start of surgical procedure) (11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with surgical conditions (bloodless field) assessed by the surgeon with a 5-point likert scale</measure>
    <time_frame>At the start of the surgical procedure</time_frame>
    <description>Satisfaction with surgical conditions (bloodless field): assessed by the surgeon with a 5-point scale. This scale is ranged (1, 2, 3, 4, 5) in which 1 stands for &quot;completely dissatisfied&quot; and 5 for &quot;completely satisfied&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative pain score: Numeric Rating Scale (NRS)</measure>
    <time_frame>every 5 min during the surgical procedure</time_frame>
    <description>Pain score (11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) at every 5 min during the surgical procedure (both surgical pain and tourniquet pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in operating room</measure>
    <time_frame>From entering the operating room until leaving the operating room</time_frame>
    <description>Time the patient is in operating room (start by entering the operating room until leaving the operating room)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of surgical procedure</measure>
    <time_frame>From start of surgical incision until closing of the surgical wound</time_frame>
    <description>Time of surgical procedure (start at surgical incision until closing of the surgical wound)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General satisfaction of the patient: Likert scale</measure>
    <time_frame>Assessed on day 1 post surgery</time_frame>
    <description>General satisfaction of the patient with the anesthesia technique (measured via a 7-point Likert scale, with 1 being completely dissatisfied and 7 being completely satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Surgery</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Bier's block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Upperarm intravenous regional anesthesia (Bier's block) with lidocaine 0.5% 40ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mini-Bier's block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forearm intravenous regional anesthesia (mini-Bier's block) with lidocaine 0.5% 25ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mini-Bier's block with lidocaine 0.5% 25ml</intervention_name>
    <description>An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions postoperatively.</description>
    <arm_group_label>Mini-Bier's block</arm_group_label>
    <other_name>forearm intravenous regional anesthesia (IVRA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional Bier's block with lidocaine 0.5% 40ml</intervention_name>
    <description>An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions postoperatively.</description>
    <arm_group_label>Bier's block</arm_group_label>
    <other_name>Upperarm intravenous regional anesthesia (IVRA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females ≥ 18 years of age&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) physical status classification: 1-3&#xD;
&#xD;
          -  Patients planned to undergo hand surgery which can be performed using either a Bier's&#xD;
             block or a mini-Bier's block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years old&#xD;
&#xD;
          -  Patients that participate in other clinical, pharmaceutical trials or trials with&#xD;
             medical devices&#xD;
&#xD;
          -  Patients that previously have been randomized in this trial&#xD;
&#xD;
          -  Patients that need to undergo surgery using sedation/general anesthesia&#xD;
&#xD;
          -  Bilateral surgery&#xD;
&#xD;
          -  BMI ≥ 40 kg/m2&#xD;
&#xD;
          -  History of neurological conditions&#xD;
&#xD;
          -  Chronic pain symptoms&#xD;
&#xD;
          -  Concomitant use of Opioids in the last month&#xD;
&#xD;
          -  Diabetes mellitus with organ damage&#xD;
&#xD;
          -  Oversensitivity to local anesthetics&#xD;
&#xD;
          -  Blood clotting disorders&#xD;
&#xD;
          -  Inability to understand and adhere to the study design&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Björn Stessel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jessa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jessa Hospital</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Chiao FB, Chen J, Lesser JB, Resta-Flarer F, Bennett H. Single-cuff forearm tourniquet in intravenous regional anaesthesia results in less pain and fewer sedation requirements than upper arm tourniquet. Br J Anaesth. 2013 Aug;111(2):271-5. doi: 10.1093/bja/aet032. Epub 2013 Mar 18.</citation>
    <PMID>23508563</PMID>
  </reference>
  <reference>
    <citation>Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.</citation>
    <PMID>20122591</PMID>
  </reference>
  <reference>
    <citation>Arslanian B, Mehrzad R, Kramer T, Kim DC. Forearm Bier block: a new regional anesthetic technique for upper extremity surgery. Ann Plast Surg. 2014 Aug;73(2):156-7. doi: 10.1097/SAP.0b013e318276da4c.</citation>
    <PMID>23407261</PMID>
  </reference>
  <reference>
    <citation>Karalezli N, Karalezli K, Iltar S, Cimen O, Aydogan N. Results of intravenous regional anaesthesia with distal forearm application. Acta Orthop Belg. 2004 Oct;70(5):401-5.</citation>
    <PMID>15587026</PMID>
  </reference>
  <reference>
    <citation>Chong AK, Tan DM, Ooi BS, Mahadevan M, Lim AY, Lim BH. Comparison of forearm and conventional Bier's blocks for manipulation and reduction of distal radius fractures. J Hand Surg Eur Vol. 2007 Feb;32(1):57-9. doi: 10.1016/j.jhsb.2006.10.002. Epub 2006 Nov 22.</citation>
    <PMID>17123673</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jessa Hospital</investigator_affiliation>
    <investigator_full_name>Stessel Björn</investigator_full_name>
    <investigator_title>Principal Investigator, Anesthesiologist, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Bier's block</keyword>
  <keyword>Mini-Bier's block</keyword>
  <keyword>Hand surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics</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/NCT03761329
org study id: 18.46/ANESTH18.03
nct id: NCT03761329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
By means of an observer-blinded, randomized controlled trial, the analgesic efficacy of an
      upper-arm Bier's block and a forearm mini-Bier's block will be investigated in patients
      undergoing hand surgery. The hypothesis is that there is no difference between the two types
      of anesthetic techniques with respect to the analgesic efficacy.
Introduction:

      Several ways of anesthesia can be used to perform hand surgery, being general anesthesia,
      intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia
      and intravenous regional anesthesia are often performed since patients can be discharged from
      the hospital more rapidly.

      A conventional Bier's block is performed using a tourniquet on the upper arm to create a
      bloodless field and to contain the anesthetics within the surgical area (1). Complications
      are rare but are often linked to a systemic toxicity reaction after releasing the tourniquet
      (2). A mini-Bier's block in which the tourniquet is placed on the fore-arm, has been shown to
      be a safe and effective way of anesthesia to perform hand surgery. By using this type of
      anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block
      which reduces the risk of systemic toxicity reactions (3-5).

      Currently, studies that made a comparison between the two anesthesia techniques are scarce
      and inconsistent. Next to that, those studies also used different types of anesthetics and
      dosages. To see which technique is advantageous in clinical practice, the investigators want
      to investigate the efficacy of the Bier's block and mini-Bier's block in patients that are
      planned to undergo hand surgery.

      Outcome measures:

      The primary aim of this study is to compare the analgesic efficacy of the Bier's block versus
      the mini-Bier's block. The hypothesis is that there is no difference between the two
      techniques. A blinded surgeon will determine the analgesic efficacy of these techniques
      (graded as "complete" or "incomplete") and divide the efficacy in 4 grades. Grade 1 and grade
      2 are considered "complete" blockade, while grade 3 and grade 4 are considered "incomplete"
      blockade. Grade 1: complete motor and sensory blockade, grade 2: partial motor blockade but
      no pain or deep pressure sensitivity, grade 3: partial motor blockade with mild pain
      requiring rescue local or opioid analgesia, grade 4: incomplete motor- and sensory blockade
      requiring sedation/conversion to general anesthesia).

      Secondary study outcomes:

        -  Onset time, which is defined as the time from the injection of the local anesthetic
           until the complete sensory loss in hand (assessed by the blinded surgeon via "pin
           prick").

        -  Patient's pre-, intra- and post-operative pain scores will be measured via an 11-point
           Numeric Rating Scale (NRS) in which number 0 means "no pain at all", number 5 means
           "moderate pain" and number 10 means "worst possible pain".

        -  Tourniquet time: the amount of time that the tourniquet is inflated.

        -  Tourniquet tolerance time: the amount of time required for the inflated tourniquet to
           cause a painful sensation (NRS > 3).

        -  Satisfaction with the surgical field (bloodless field) will be graded by a blinded
           surgeon, measured using a 5-point scale (1= extremely dissatisfied until 5= extremely
           satisfied).

        -  The time spent in the operating room.

        -  Duration of surgery.

        -  General patient satisfaction will be assessed using a 7-point Likert Scale, in which
           number 1 equals "extremely dissatisfied" and number 7 means "extremely satisfied".

      Design:

      In this monocentric, investigator-initiated, observer-blinded, prospective, randomized,
      controlled, non-inferiority trial, 2 anaesthetic procedures will be compared in patients that
      undergo hand surgery (Carpal Tunnel Syndrome, trigger finger, dequervain tenovaginitis,
      disease of Dupuytren, ganglion cyst).

      This study will be performed according to the Declaration of Helsinki and will be approved by
      the ethics committee of the JESSA Hospital, Hasselt, Belgium before the start of the study. A
      written informed consent will be obtained before participation in the study.

      Randomization will be performed using a computer-generated random allocation sequence.
      Allocation numbers will be sealed in opaque envelopes, which will be opened in sequence by an
      independent anesthesiologist who is not involved in the assessment of outcomes.

      Both the surgeon and the researcher will be blinded for the used type of anesthesia. Since
      the clear difference between an upper arm and forearm tourniquet, all patients will receive a
      second tourniquet which will not be inflated. That is, patients receiving the Bier's block
      will receive an additional forearm tourniquet which will not be inflated and patients in
      group of the mini-Bier's block will receive an additional upperarm tourniquet which will not
      be inflated. In this way, a possible de-blinding of the surgeon and researcher is minimized.

      Study Procedures:

      The patient will first receive information about this study. Before the start of the study,
      written informed consent will be obtained, after which the patient will be randomized to one
      of the 2 treatment groups. Before surgery, all patients will receive an intravenous catheter
      in the contralateral arm with infusion of 0.9% Natriumchloride (NaCl), paracetamol 1g and
      standard monitoring (non-invasive blood pressure, electrocardiogram and O2 saturation
      measurements).

      In the Bier's block group:

      An intravenous catheter will be placed in the dorsal vein of the hand that will undergo
      surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which
      the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The
      tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions
      postoperatively.

      In the mini-Bier's block group:

      An intravenous catheter will be placed in the dorsal vein of the hand that will undergo
      surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the
      anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The
      tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions
      postoperatively.

      Before the start of the surgery, the blinded surgeon will assess the quality of the block
      (primary outcome) using a forceps. The quality of the block will be graded "complete" or
      "incomplete" as described above. In case of grade 1 or grade 2, the surgical procedure can
      start. In case of grade 3, the blockade will be enhanced (local anesthetic or intravenous
      opioid administration (alfentanil or sufentanil)). In case of grade 4, sedation/conversion to
      general anesthesia will be performed.

      All secondary outcome measures will be investigated by the blinded researcher.

      Statistical analysis:

      Sample size was determined for the primary study outcome with the aim to reject the
      non-inferiority of the mini-Bier's block. Based on a meta-analysis (unpublished data) we
      expect a 98.5% complete blockade in the experimental group (mini-Bier's block) and a 100%
      complete blockade in the control group (Bier's block). With a difference of 5% between the 2
      groups and a binary outcome (complete/incomplete), we calculated that 135 patients are needed
      per group (α=0.05, power=0.80). Considering a drop-out rate of 3.5%, the total number of
      patients is 140 per group.

      Descriptive statistics will be presented as frequencies and percentages of the total amount
      of patients for categorical variables, while numerical variables will be presented as mean.
      Group comparison will be performed using Chi-square test (or a Fisher's Exact test when
      necessary) for frequencies. Depending on normality, a Mann-Whitney U test or a Student's
      t-test will be used. Corrections will be applied for multiple measurements of the Numerical
      Rating Scale (NRS) for pain scores. An average difference of 1.3 points or more on the NRS
      pain score is considered clinical relevant. A p-value <0.05 is considered statistical
      significant, while p<0.10 is considered a tendency.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Sensory and motor block of the hand
time frame: 5 minutes after injection of lidocaine 0.5%
description: This study wants to evaluate and compare the analgesic efficacy of the Bier's block with the mini-Bier's block. The blinded surgeon will assess the analgesic effectivity and grade it as either complete (grade 1 and grade 2) or incomplete (grade 3 and grade 4). Grade 1 is defined as complete motor and sensory blockade; grade 2 is defined as partial motor blockade with no pain or deep pressure sensitivity. Grade 3 is defined as partial motor blockade with mild pain and the need for rescue local or opioid analgesia. Grade 4 is defined as incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.
measure: Pre-operative pain score: Numeric Rating Scale (NRS)
time frame: Before the start of anesthesia technique
description: Pain score before the start of anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
measure: Pain due to anesthesia technique: Numeric Rating Scale (NRS)
time frame: At the end of performing the anesthesia technique
description: Pain caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
measure: Tourniquet time
time frame: From start of inflation until deflation of the tourniquet
description: Total time the tourniquet is inflated
measure: Onset time of analgesia
time frame: At injection of the anaesthetic until complete blockade of the sensory nerves
description: Onset time of analgesia (starts at injection of the anaesthetic and will continue until complete blockade of the sensory nerves (assessed via pin prick)). When after 10 minutes no sensory blockade occurred, rescue medication (alfentanil (0,5 mg)) will be applied. When alfentanil (0,5 mg) will not provide enough sensory blockade, sedation with diprivan (titration per 1cc) or, if required, conversion to general anesthesia will be applied.
measure: Tourniquet tolerance time
time frame: From start of inflation until deflation of the tourniquet
description: Time required for the tourniquet to cause a painful sensation (NRS > 3)
measure: Pain score at start of surgery (surgical incision): Numeric Rating Scale (NRS)
time frame: At the start of the surgical procedure
description: Pain score at surgical incision (start of surgical procedure) (11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
measure: Satisfaction with surgical conditions (bloodless field) assessed by the surgeon with a 5-point likert scale
time frame: At the start of the surgical procedure
description: Satisfaction with surgical conditions (bloodless field): assessed by the surgeon with a 5-point scale. This scale is ranged (1, 2, 3, 4, 5) in which 1 stands for "completely dissatisfied" and 5 for "completely satisfied".
measure: Intraoperative pain score: Numeric Rating Scale (NRS)
time frame: every 5 min during the surgical procedure
description: Pain score (11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable) at every 5 min during the surgical procedure (both surgical pain and tourniquet pain)
measure: Time in operating room
time frame: From entering the operating room until leaving the operating room
description: Time the patient is in operating room (start by entering the operating room until leaving the operating room)
measure: Time of surgical procedure
time frame: From start of surgical incision until closing of the surgical wound
description: Time of surgical procedure (start at surgical incision until closing of the surgical wound)
measure: General satisfaction of the patient: Likert scale
time frame: Assessed on day 1 post surgery
description: General satisfaction of the patient with the anesthesia technique (measured via a 7-point Likert scale, with 1 being completely dissatisfied and 7 being completely satisfied)
arm group label: Bier's block
arm group type: Active Comparator
description: Upperarm intravenous regional anesthesia (Bier's block) with lidocaine 0.5% 40ml
arm group label: Mini-Bier's block
arm group type: Experimental
description: Forearm intravenous regional anesthesia (mini-Bier's block) with lidocaine 0.5% 25ml
intervention type: Procedure
intervention name: mini-Bier's block with lidocaine 0.5% 25ml
description: An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions postoperatively.
arm group label: Mini-Bier's block
other name: forearm intravenous regional anesthesia (IVRA)
intervention type: Procedure
intervention name: Conventional Bier's block with lidocaine 0.5% 40ml
description: An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions postoperatively.
arm group label: Bier's block
other name: Upperarm intravenous regional anesthesia (IVRA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Björn Stessel, MD, PhD
role: Principal Investigator
affiliation: Jessa Hospital
facility: 
country: Belgium
citation: Chiao FB, Chen J, Lesser JB, Resta-Flarer F, Bennett H. Single-cuff forearm tourniquet in intravenous regional anaesthesia results in less pain and fewer sedation requirements than upper arm tourniquet. Br J Anaesth. 2013 Aug;111(2):271-5. doi: 10.1093/bja/aet032. Epub 2013 Mar 18.
PMID: 23508563
citation: Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.
PMID: 20122591
citation: Arslanian B, Mehrzad R, Kramer T, Kim DC. Forearm Bier block: a new regional anesthetic technique for upper extremity surgery. Ann Plast Surg. 2014 Aug;73(2):156-7. doi: 10.1097/SAP.0b013e318276da4c.
PMID: 23407261
citation: Karalezli N, Karalezli K, Iltar S, Cimen O, Aydogan N. Results of intravenous regional anaesthesia with distal forearm application. Acta Orthop Belg. 2004 Oct;70(5):401-5.
PMID: 15587026
citation: Chong AK, Tan DM, Ooi BS, Mahadevan M, Lim AY, Lim BH. Comparison of forearm and conventional Bier's blocks for manipulation and reduction of distal radius fractures. J Hand Surg Eur Vol. 2007 Feb;32(1):57-9. doi: 10.1016/j.jhsb.2006.10.002. Epub 2006 Nov 22.
PMID: 17123673
responsible party type: Principal Investigator
investigator affiliation: Jessa Hospital
investigator full name: Stessel Björn
investigator title: Principal Investigator, Anesthesiologist, MD, PhD
mesh term: Lidocaine
mesh term: Anesthetics
sharing ipd: No