<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/NCT02984800</url>
  </required_header>
  <id_info>
    <org_study_id>3122016</org_study_id>
    <nct_id>NCT02984800</nct_id>
  </id_info>
  <brief_title>Effectiveness of Single Paravertebral Blockade Injection for Herniorrhaphy in Children</brief_title>
  <official_title>The Anesthetic and Analgesic Effectiveness of Single Paravertebral Blockade Injection for Herniorrhaphy in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</source>
  <brief_summary>
    <textblock>
      Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its&#xD;
      unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged&#xD;
      postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,&#xD;
      timely and effective technique generates the investigation of a single PVB injection for&#xD;
      children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind&#xD;
      this investigation. First, possible spread of single PVB injection in the lumbar area over&#xD;
      dermatomes corresponding to the inguinal hernia region in children likewise the spread over&#xD;
      multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal&#xD;
      region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,&#xD;
      all three arising from L1-L2 level; thus, a single PVB injection at this level could provide&#xD;
      unilateral segmental anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted prospectively, using a randomized double-blinded design. Male&#xD;
      patients scheduled for elective unilateral herniorrhaphy will be included in the study.&#xD;
&#xD;
      Patients will be randomly allocated into two groups using the sealed envelope technique. All&#xD;
      patients will have inhaled induction of anesthesia by facemask using oxygen and 8%&#xD;
      sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB&#xD;
      injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained&#xD;
      until completion of surgery.&#xD;
&#xD;
      Then, group I will receive one PVB injection at L1-L2 and placebo PVB injections at T12-L1&#xD;
      and L2-L3. Group III will receive three PVB injections at T12-L1, L1-L2 and L2-L3.&#xD;
&#xD;
      Paravertebral block technique After induction of anesthesia and placement of regular&#xD;
      anesthetic monitors, three unilateral PVBs will be performed with the child lying in the&#xD;
      lateral position with the operative side uppermost. The needle insertion sites will be&#xD;
      1.5-2.0 cm lateral to the midline depending on the age and the body mass index of the child.&#xD;
&#xD;
      After aseptic preparation of the skin, a nerve stimulator (Stimuplex, B Braun AG, Melsungen,&#xD;
      Germany) is used to identify an evoked muscular contraction appropriate for the levels. A 50&#xD;
      mm 21G insulated needle (Stimuplex A, B Braun AG) will be introduced perpendicular to the&#xD;
      skin using 5 mA and 1 Hz. Then, the stimulating needle is gently manipulated to allow for&#xD;
      adequate muscle response with a stimulating current of 0.4-0.6 mA.&#xD;
&#xD;
      In order to preserve the double-blindness of this trial, an independent nurse will prepare&#xD;
      three syringes. Each syringe is labeled with the corresponding level of injection i.e,&#xD;
      T12-L1, L1-L2 and L2-L3. The T12-L1 and L2-L3 syringes that will be used for group I will&#xD;
      contain 0.45 ml placebo (0.9% normal saline) per syringe. The syringe labeled L1-L2 will&#xD;
      contain 0.45 ml local anesthesia. On the other hand, the three syringes that will be used for&#xD;
      group III will contain 0.15 ml local anesthesia and 0.3 ml placebo. Consequently, all&#xD;
      patients will receive a total of 0.45 ml anesthesia and 0.9 ml placebo.&#xD;
&#xD;
      Data collection Demographic data such as age, weight and height will be collected.&#xD;
      Non-invasive mean arterial blood pressure and heart rate will be recorded preoperatively&#xD;
      (baseline), intraoperatively (incision of skin, dissection of hernia, traction over the sac&#xD;
      and closure of incision) and immediately postoperatively. During the operation, any&#xD;
      hemodynamic changes in excess of 15% from baseline values will result in a step-wise increase&#xD;
      or decrease of the sevoflurane concentration. Intra-operative sevoflurane concentration will&#xD;
      be recorded.&#xD;
&#xD;
      Postoperative pain assessment and analgesia As for pain assessment, the Face, Legs, Activity,&#xD;
      Cry, Consolability (FLACC) scale will be used to measure postoperative pain (0 indicating no&#xD;
      pain and 10 maximum possible pain).&#xD;
&#xD;
      Patients with pain score greater than 4 are given 1-2 mg/kg Tramadol hydrochloride (Tramal&#xD;
      drops, Laboratoire Grunenthal, Aachen, Germany) A 350 mg paracetamol suppository (Tylenol&#xD;
      CILAG SA, Schaffhouse, Switzerland) will be prescribed in pain score is less than 5.&#xD;
&#xD;
      During hospitalization trained nurses, blinded to the randomization, will collect the pain&#xD;
      scores. Following hospital discharge, pain scores will be assessed by parents through phone&#xD;
      calls made by the same nurses during the first postoperative day at predetermined time&#xD;
      intervals (0h, 6h, 12h, 24h).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic consumption</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Analgesics consumed will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic stability</measure>
    <time_frame>During the operation (approximately one hour)</time_frame>
    <description>Hemodynamic stability measured through mean arterial pressure (MAP)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Reduce Pain After Herniorrhaphy</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive one PVB injection at L1-L2 .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive three PVB injections at T12-L1, L1-L2 and L2-L3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anesthesia induction</intervention_name>
    <description>All patients will have inhaled induction of anesthesia by facemask using oxygen and 8% sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained until completion of surgery.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PVB injection at L1-L2</intervention_name>
    <description>Patients will receive a single PVB injection at L1-L2 and placebo PVB injections at T12-L1 and L2-L3.</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PVB injections at T12-L1, L1-L2 and L2-L3.</intervention_name>
    <description>Patients will have PVB injections at T12-L1, L1-L2 and L2-L3.</description>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective unilateral herniorrhaphy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of allergic reactions to local anesthetics&#xD;
&#xD;
          -  bleeding diatheses&#xD;
&#xD;
          -  spinal abnormality&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zoher Naja, MD</last_name>
    <phone_ext>6405</phone_ext>
    <email>zouhnaja@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zoher Naja, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6405</phone_ext>
      <email>zouhnaja@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Zoher Naja</investigator_full_name>
    <investigator_title>Chairperson of Anesthesia and Pain Management Department</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02984800
org study id: 3122016
nct id: NCT02984800
lead sponsor: 
Paravertebral block (PVB) might be a technique of choice for hernia surgery due to its
      unilateral segmental anesthesia of the operative site, good muscle relaxation and prolonged
      postoperative analgesia. Despite PVB effectiveness, a continuing search for a reliable,
      timely and effective technique generates the investigation of a single PVB injection for
      children undergoing unilateral inguinal hernia repair. Two theoretical concepts were behind
      this investigation. First, possible spread of single PVB injection in the lumbar area over
      dermatomes corresponding to the inguinal hernia region in children likewise the spread over
      multiple adjacent segments from a single thoracic PVB injection. Second, as the inguinal
      region receives innervation from the ilioinguinal, iliohypogastric and genitofemoral nerves,
      all three arising from L1-L2 level; thus, a single PVB injection at this level could provide
      unilateral segmental anesthesia.
The study will be conducted prospectively, using a randomized double-blinded design. Male
      patients scheduled for elective unilateral herniorrhaphy will be included in the study.

      Patients will be randomly allocated into two groups using the sealed envelope technique. All
      patients will have inhaled induction of anesthesia by facemask using oxygen and 8%
      sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB
      injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained
      until completion of surgery.

      Then, group I will receive one PVB injection at L1-L2 and placebo PVB injections at T12-L1
      and L2-L3. Group III will receive three PVB injections at T12-L1, L1-L2 and L2-L3.

      Paravertebral block technique After induction of anesthesia and placement of regular
      anesthetic monitors, three unilateral PVBs will be performed with the child lying in the
      lateral position with the operative side uppermost. The needle insertion sites will be
      1.5-2.0 cm lateral to the midline depending on the age and the body mass index of the child.

      After aseptic preparation of the skin, a nerve stimulator (Stimuplex, B Braun AG, Melsungen,
      Germany) is used to identify an evoked muscular contraction appropriate for the levels. A 50
      mm 21G insulated needle (Stimuplex A, B Braun AG) will be introduced perpendicular to the
      skin using 5 mA and 1 Hz. Then, the stimulating needle is gently manipulated to allow for
      adequate muscle response with a stimulating current of 0.4-0.6 mA.

      In order to preserve the double-blindness of this trial, an independent nurse will prepare
      three syringes. Each syringe is labeled with the corresponding level of injection i.e,
      T12-L1, L1-L2 and L2-L3. The T12-L1 and L2-L3 syringes that will be used for group I will
      contain 0.45 ml placebo (0.9% normal saline) per syringe. The syringe labeled L1-L2 will
      contain 0.45 ml local anesthesia. On the other hand, the three syringes that will be used for
      group III will contain 0.15 ml local anesthesia and 0.3 ml placebo. Consequently, all
      patients will receive a total of 0.45 ml anesthesia and 0.9 ml placebo.

      Data collection Demographic data such as age, weight and height will be collected.
      Non-invasive mean arterial blood pressure and heart rate will be recorded preoperatively
      (baseline), intraoperatively (incision of skin, dissection of hernia, traction over the sac
      and closure of incision) and immediately postoperatively. During the operation, any
      hemodynamic changes in excess of 15% from baseline values will result in a step-wise increase
      or decrease of the sevoflurane concentration. Intra-operative sevoflurane concentration will
      be recorded.

      Postoperative pain assessment and analgesia As for pain assessment, the Face, Legs, Activity,
      Cry, Consolability (FLACC) scale will be used to measure postoperative pain (0 indicating no
      pain and 10 maximum possible pain).

      Patients with pain score greater than 4 are given 1-2 mg/kg Tramadol hydrochloride (Tramal
      drops, Laboratoire Grunenthal, Aachen, Germany) A 350 mg paracetamol suppository (Tylenol
      CILAG SA, Schaffhouse, Switzerland) will be prescribed in pain score is less than 5.

      During hospitalization trained nurses, blinded to the randomization, will collect the pain
      scores. Following hospital discharge, pain scores will be assessed by parents through phone
      calls made by the same nurses during the first postoperative day at predetermined time
      intervals (0h, 6h, 12h, 24h).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Analgesic consumption
time frame: 24 hours postoperatively
description: Analgesics consumed will be recorded
measure: Hemodynamic stability
time frame: During the operation (approximately one hour)
description: Hemodynamic stability measured through mean arterial pressure (MAP)
arm group label: Group I
arm group type: Experimental
description: Patients will receive one PVB injection at L1-L2 .
arm group label: Group III
arm group type: Experimental
description: Patients will receive three PVB injections at T12-L1, L1-L2 and L2-L3.
intervention type: Other
intervention name: Anesthesia induction
description: All patients will have inhaled induction of anesthesia by facemask using oxygen and 8% sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained until completion of surgery.
arm group label: Group I
arm group label: Group III
intervention type: Other
intervention name: PVB injection at L1-L2
description: Patients will receive a single PVB injection at L1-L2 and placebo PVB injections at T12-L1 and L2-L3.
arm group label: Group I
intervention type: Other
intervention name: PVB injections at T12-L1, L1-L2 and L2-L3.
description: Patients will have PVB injections at T12-L1, L1-L2 and L2-L3.
arm group label: Group III
criteria: 
gender: Male
minimum age: 2 Months
maximum age: 7 Years
healthy volunteers: No
last name: Zoher Naja, MD
phone ext: 6405
email: zouhnaja@yahoo.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Zoher Naja
investigator title: Chairperson of Anesthesia and Pain Management Department
mesh term: Anesthetics