<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/NCT03805503</url>
  </required_header>
  <id_info>
    <org_study_id>EC/2014/1264</org_study_id>
    <nct_id>NCT03805503</nct_id>
  </id_info>
  <brief_title>Chloroprocaine for Inguinal Herniorrhaphy</brief_title>
  <official_title>Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
      This study is to determine the minimum effective dose for intrathecal chloroprocaine in&#xD;
      inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A standard CSE procedure will be conducted in which the patient is placed in an upright&#xD;
      sitting position on the side of the operation table and a epidural Tuohy needle 18G will be&#xD;
      inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured&#xD;
      using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be&#xD;
      given. After the spinal needle is withdrawn, an epidural catheter will be placed and the&#xD;
      epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a&#xD;
      supine position.&#xD;
&#xD;
      The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been&#xD;
      successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate&#xD;
      analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the&#xD;
      analgesia. The testing interval is 2 mg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2015</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">September 7, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Prospective, up-down sequential allocation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome</measure>
    <time_frame>start of surgery</time_frame>
    <description>MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak block height</measure>
    <time_frame>during surgery</time_frame>
    <description>highest sensible block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for regression of two segments</measure>
    <time_frame>during surgery</time_frame>
    <description>Time for regression of two segments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulation time</measure>
    <time_frame>From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery</time_frame>
    <description>motor recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to micturition</measure>
    <time_frame>From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery</time_frame>
    <description>Time to micturition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)</measure>
    <time_frame>perioperative</time_frame>
    <description>Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery</time_frame>
    <description>Time to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with anesthesia method: questionnaire</measure>
    <time_frame>postoperatively,at moment of hospital discharge measured up to 6 hours after surgery</time_frame>
    <description>Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>chloroprocaine 1% injectable solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%.&#xD;
An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study.&#xD;
An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroprocaine 1% Injectable Solution</intervention_name>
    <description>standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg.&#xD;
Efficacy of the analgesia will be evaluated:&#xD;
Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia.&#xD;
Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed.</description>
    <arm_group_label>chloroprocaine 1% injectable solution</arm_group_label>
    <other_name>chloroprocaine 3%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients for unilateral inguinal hernia repair&#xD;
&#xD;
          -  ASA I - II - III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or&#xD;
             sufentanil&#xD;
&#xD;
          -  contraindications to spinal or epidural anesthesia&#xD;
&#xD;
          -  bilateral inguinal herniorrhaphy&#xD;
&#xD;
          -  extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)&#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>Aliaksandra Parashchanka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>stafmember department of Anesthesiology</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chloroprocaine</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>one-day clinic</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroprocaine</mesh_term>
    <mesh_term>Procaine</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/NCT03805503
org study id: EC/2014/1264
nct id: NCT03805503
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to determine the minimum effective dose for intrathecal chloroprocaine in
      inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.
A standard CSE procedure will be conducted in which the patient is placed in an upright
      sitting position on the side of the operation table and a epidural Tuohy needle 18G will be
      inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured
      using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be
      given. After the spinal needle is withdrawn, an epidural catheter will be placed and the
      epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a
      supine position.

      The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been
      successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate
      analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the
      analgesia. The testing interval is 2 mg.
intervention model: Sequential Assignment
intervention model description: Prospective, up-down sequential allocation
primary purpose: Treatment
masking: None (Open Label)
measure: The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
time frame: start of surgery
description: MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery
measure: Peak block height
time frame: during surgery
description: highest sensible block
measure: Time for regression of two segments
time frame: during surgery
description: Time for regression of two segments
measure: Ambulation time
time frame: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
description: motor recovery
measure: Time to micturition
time frame: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
description: Time to micturition
measure: Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
time frame: perioperative
description: Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
measure: Time to discharge
time frame: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
description: Time to discharge
measure: Patient satisfaction with anesthesia method: questionnaire
time frame: postoperatively,at moment of hospital discharge measured up to 6 hours after surgery
description: Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
arm group label: chloroprocaine 1% injectable solution
arm group type: Experimental
description: Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%.
An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study.
An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study.
intervention type: Drug
intervention name: Chloroprocaine 1% Injectable Solution
description: standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg.
Efficacy of the analgesia will be evaluated:
Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia.
Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed.
arm group label: chloroprocaine 1% injectable solution
other name: chloroprocaine 3%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aliaksandra Parashchanka, MD
role: Principal Investigator
affiliation: stafmember department of Anesthesiology
responsible party type: Sponsor
mesh term: Chloroprocaine
mesh term: Procaine
sharing ipd: No