<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/NCT04462510</url>
  </required_header>
  <id_info>
    <org_study_id>AgaKhanU1</org_study_id>
    <nct_id>NCT04462510</nct_id>
  </id_info>
  <brief_title>To Compare Ilioinguinal/Iliohypogastric Block to Wound Infiltration for Pain Relief After Hernia Repair in Adults</brief_title>
  <official_title>A Comparison Between Ultrasound Guided Ilioinguial/Iliohyphogastic Nerves Block and Infiltration of Wound With Ropivacaine on Post-Operative Pain After Open Repair of Unilateral Inguinal Hernia in Adults: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to assess the postoperative painscores in patients undergoing open&#xD;
      inguinal hernia repair between two groups receiving either U/S guided&#xD;
      ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with&#xD;
      Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves&#xD;
      blocks and wound infiltration) was measured alongwith comparison of opioid use between the&#xD;
      two groups over 24 hours postoperatively was made. Patient satisfaction between the two&#xD;
      groups was also assessed by the Likert scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal&#xD;
      analgesia is recommended to overcome this issue. Therefore this randomized controlled trial&#xD;
      was conducted to compare the analgesic efficacy of ultrasound guided&#xD;
      Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with&#xD;
      Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.&#xD;
&#xD;
      This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised&#xD;
      controlled trial conducted from March 2019 to October 2019. 60 participants for elective&#xD;
      unilateral open inguinal hernia repair were included. Patients were randomly allocated (30&#xD;
      each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25%&#xD;
      Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local&#xD;
      anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site&#xD;
      to provide postoperative analgesia. Postoperative pain at rest (static) and on movement&#xD;
      (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain,&#xD;
      7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol&#xD;
      consumption and time for first tramadol requirement was noted.&#xD;
&#xD;
      In addition complications related to IHG block and LA infiltration were observed.Patient&#xD;
      satisfaction was also gauged by the LIKERT scale in the questionairre.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2019</start_date>
  <completion_date type="Actual">October 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</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>
    <intervention_model_description>Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The patients were randomized using computer generated numbers and did not know which group did they fall in</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>This was measured at 0 hours (immediately) after the surgery</time_frame>
    <description>Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>This was measured at 2 hours after the surgery</time_frame>
    <description>Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>This was measured at 6 hours after the surgery</time_frame>
    <description>Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>This was measured at 12 hours after the surgery</time_frame>
    <description>Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>This was measured 24 hours after the surgery</time_frame>
    <description>Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tramadol consumption</measure>
    <time_frame>This was measured at 0,2,6,12 and 24 hours after the surgery</time_frame>
    <description>Amount of total tramadol consumption was recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>This was assessed at the end of 24 hours post operatively.</time_frame>
    <description>This was measured on a 5 point Likert scale. A question was asked that 'was the anesthetic care and pain relief effective?' The scale included the options of Strongly disagree, Disagree, Neutral, Agree, Strongly Agree</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>To Compare ILI/IHG Block to Wound Infiltration for Pain Relief After Hernia Repair</condition>
  <arm_group>
    <arm_group_label>Illioinguinal/Illiohypogastric Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wound infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Block/Local infiltration</intervention_name>
    <description>One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief</description>
    <arm_group_label>Illioinguinal/Illiohypogastric Block</arm_group_label>
    <arm_group_label>Wound infiltration</arm_group_label>
    <other_name>ILI/IHG Block</other_name>
    <other_name>Local Infiltration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients between the ages of 18-75 years, scheduled for unilateral open primary&#xD;
             hernia repair electively&#xD;
&#xD;
          -  American society of Anaesthesiologists(ASA) standard I to IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI below 18 or above 35 kg/m2&#xD;
&#xD;
          -  Local anesthetic allergy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Infection at injection site&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Contraindication to any drug used in the standard anesthesia regimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Summaiya Ali, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesia Resident</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <zip>75500</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Summaiya Ahsan Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_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/NCT04462510
org study id: AgaKhanU1
nct id: NCT04462510
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study was conducted to assess the postoperative painscores in patients undergoing open
      inguinal hernia repair between two groups receiving either U/S guided
      ilioinguinal/iliohypogastric nerves block with Ropivacaine or wound infiltration with
      Ropivacaine.The safety of two analgesic interventions(ilioinguinal/iliohypogastric nerves
      blocks and wound infiltration) was measured alongwith comparison of opioid use between the
      two groups over 24 hours postoperatively was made. Patient satisfaction between the two
      groups was also assessed by the Likert scale.
Pain is a concerning problem in patients with open inguinal hernia repair. Hence, multi modal
      analgesia is recommended to overcome this issue. Therefore this randomized controlled trial
      was conducted to compare the analgesic efficacy of ultrasound guided
      Ilioinguinal/Iliohyphogastric nerve block vs. local anaesthetic infiltration of wound with
      Ropivacaine on postoperative pain after open repair of unilateral inguinal hernia in adults.

      This study was conducted at Aga Khan University Hospital Karachi.It is a Randomised
      controlled trial conducted from March 2019 to October 2019. 60 participants for elective
      unilateral open inguinal hernia repair were included. Patients were randomly allocated (30
      each) to one of the two groups. Group I received ILI/IHG nerve block where 20mls 0.25%
      Ropivacaine was infiltrated around the nerves under U/S guidance, and group II received local
      anaesthetic infiltration (Ropivacaine 20mls 0.25%) at the end of surgery at the incision site
      to provide postoperative analgesia. Postoperative pain at rest (static) and on movement
      (dynamic) was assessed on VRS scale at 0= no pain , 1-3=mild pain, 4-6=moderate pain,
      7-10=severe pain at 0, 2,6, 12, 24 hours, either in person or telephone. Total tramadol
      consumption and time for first tramadol requirement was noted.

      In addition complications related to IHG block and LA infiltration were observed.Patient
      satisfaction was also gauged by the LIKERT scale in the questionairre.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single blinded where the patients were blinded. They were randomly divided into local infiltration group or illioinguinal/illiohypograstric block
primary purpose: Treatment
masking: Single (Participant)
masking description: The patients were randomized using computer generated numbers and did not know which group did they fall in
measure: Pain score
time frame: This was measured at 0 hours (immediately) after the surgery
description: Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.
measure: Pain score
time frame: This was measured at 2 hours after the surgery
description: Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.
measure: Pain score
time frame: This was measured at 6 hours after the surgery
description: Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.
measure: Pain score
time frame: This was measured at 12 hours after the surgery
description: Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.
measure: Pain score
time frame: This was measured 24 hours after the surgery
description: Pain score was measured using visual analog scale. (VAS). Score of 0-3 was taken as mild pain, 4-6 moderate pain and score of 7-10 was severe pain.
measure: Tramadol consumption
time frame: This was measured at 0,2,6,12 and 24 hours after the surgery
description: Amount of total tramadol consumption was recorded
measure: Patient satisfaction
time frame: This was assessed at the end of 24 hours post operatively.
description: This was measured on a 5 point Likert scale. A question was asked that 'was the anesthetic care and pain relief effective?' The scale included the options of Strongly disagree, Disagree, Neutral, Agree, Strongly Agree
arm group label: Illioinguinal/Illiohypogastric Block
arm group type: Experimental
description: A single shot 20ml of 0.25% Ropivacaine was used to block illioinguinal/illiohypogastric nerves using ultrasound right before incision was given
arm group label: Wound infiltration
arm group type: Experimental
description: Surgeon infiltrated the wound using 20ml of 0.25% Ropivacaine right after the skin was closed.
intervention type: Procedure
intervention name: Block/Local infiltration
description: One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief
arm group label: Illioinguinal/Illiohypogastric Block
arm group label: Wound infiltration
other name: ILI/IHG Block
other name: Local Infiltration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Summaiya Ali, MBBS
role: Principal Investigator
affiliation: Anesthesia Resident
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Summaiya Ahsan Ali
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Wounds and Injuries