xml: <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/NCT05995301</url>
    </required_header>
    <id_info>
      <org_study_id>NAMS Bir Hospital</org_study_id>
      <nct_id>NCT05995301</nct_id>
    </id_info>
    <brief_title>Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery</brief_title>
    <official_title>Comparative Study on Postoperative Analgesia With Transversus Abdominis Plane Block to Local Anesthetic Infiltration With Ropivacaine in Laparoscopic Abdominal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Academy of Medical Sciences, Nepal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Academy of Medical Sciences, Nepal</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>
        The goal of this clinical trial is to compare the postoperative analgesic efficacy of&#xD;
        ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients&#xD;
        undergoing laparoscopic surgery. The main question it aims to answer is:&#xD;
  &#xD;
        • If Transversus Abdominis Plane block with Ropivacaine will produce long duration of&#xD;
        analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic&#xD;
        abdominal surgery .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience&#xD;
        associated with actual or potential tissue damage. Pain is distressing and detrimental in&#xD;
        post-operative patients. Management of post-operative pain has been a challenge to&#xD;
        anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease&#xD;
        length of stay, reduced hospital costs, increased patient satisfaction, increase productivity&#xD;
        and quality of life.&#xD;
  &#xD;
        Peripheral nerve blockade or field block with local anesthesia is helpful in managing&#xD;
        postoperative pain effectively whilst avoiding complication associated with intravenous&#xD;
        narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency&#xD;
        of intravenous narcotics used in postoperative period, hence minimizing the side effects of&#xD;
        narcotics.&#xD;
  &#xD;
        Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and&#xD;
        analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that&#xD;
        results in anesthesia of the abdominal wall. This plane represents an anatomical potential&#xD;
        space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus&#xD;
        abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia&#xD;
        following laparoscopic surgery.&#xD;
  &#xD;
        Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been&#xD;
        safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post&#xD;
        operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side)&#xD;
        expecting to cover the upper abdomen when TAP block is performed via posterior approach.&#xD;
  &#xD;
        NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis&#xD;
        Plane block and local anesthetic infiltration after laparoscopicabdominal surgery&#xD;
  &#xD;
        General objective&#xD;
  &#xD;
        1. To compare the efficacy of Transversus Abdominal plane block and local anesthetic&#xD;
        infiltration after laparoscopic abdominal surgery&#xD;
  &#xD;
        Specific objective&#xD;
  &#xD;
          1. To compare the visual analog score (VAS) between two groups&#xD;
  &#xD;
          2. To compare time to first analgesic requirement between two groups.&#xD;
  &#xD;
          3. To compare the total dose of analgesia in 24 hours between the two groups&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 12, 2022</start_date>
    <completion_date type="Actual">February 25, 2023</completion_date>
    <primary_completion_date type="Actual">November 12, 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>
      <intervention_model_description>Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of analgesia</measure>
      <time_frame>Time Frame: upto first 24 hour after intervention</time_frame>
      <description>Visual analog scale at rest</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of analgesia</measure>
      <time_frame>Time Frame: upto first 24 hour after intervention</time_frame>
      <description>Visual analog scale on movement</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Time to first rescue analgesia</measure>
      <time_frame>Time Frame: upto first 24 hour after intervention</time_frame>
      <description>The time of first complaint of pain by the patient.</description>
    </other_outcome>
    <other_outcome>
      <measure>Total pethidine consumption</measure>
      <time_frame>Time Frame: upto first 24 hour after intervention</time_frame>
      <description>At any point of time when VAS was&gt;3, injection pethidine 0.5 mg/kg and injection promethazine 0.25 mg/kg was given via intravenous route</description>
    </other_outcome>
    <other_outcome>
      <measure>Total ketorolac consumption</measure>
      <time_frame>Time Frame: upto first 24 hour after intervention</time_frame>
      <description>When pain persisted for more than 15 min after giving intravenous pethidine, injection ketorolac 30 mg intravenous was given</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Analgesia</condition>
    <condition>Ropivacaine</condition>
    <condition>Laparoscopic Abdominal Surgery</condition>
    <condition>Local Infiltration</condition>
    <arm_group>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Transversus Abdominis Plane block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Local infiltration</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine in Transversus abdominis plane</intervention_name>
      <description>This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery</description>
      <arm_group_label>Group I</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine in Local infiltration at port site</intervention_name>
      <description>This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery</description>
      <arm_group_label>Group II</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients of either sex aged 25-70 years&#xD;
  &#xD;
            2. ASA physical status I or II&#xD;
  &#xD;
            3. Patient posted for elective abdominal laparoscopic surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Any absolute contraindications to peripheral nerve blockade&#xD;
  &#xD;
            2. History of Hypersensitivity to Drugs&#xD;
  &#xD;
            3. Uncontrolled Diabetes Mellitus, Renal Failure, Hepatic failure&#xD;
  &#xD;
            4. History of neuromuscular or psychiatric disease&#xD;
  &#xD;
            5. Patient receiving psychotropic drug, chronic analgesic therapy&#xD;
  &#xD;
            6. Pregnancy&#xD;
  &#xD;
            7. Patient weight less than 50 kg&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Surendra Bhusal, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Brihaspati K C, MD</last_name>
      <role>Study Director</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kaushal Tamang, MD</last_name>
      <role>Study Chair</role>
      <affiliation>NAMS Bir Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Academy of Medical Sciences</name>
        <address>
          <city>Kathmandu</city>
          <state>Bagmati</state>
          <zip>977</zip>
          <country>Nepal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Academy of Medical Sciences, Nepal</investigator_affiliation>
      <investigator_full_name>Surendra Bhusal</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Ropivacaine</keyword>
    <keyword>TAP Block</keyword>
    <keyword>Analgesia</keyword>
    <keyword>Laparoscopic abdominal surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Agnosia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995301
  org study id: NAMS Bir Hospital
  nct id: NCT05995301
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the postoperative analgesic efficacy of
        ultrasound-guided TAP block with Local Anesthetic Infiltration of ropivacaine in patients
        undergoing laparoscopic surgery. The main question it aims to answer is:
  
        • If Transversus Abdominis Plane block with Ropivacaine will produce long duration of
        analgesia than the Local Anesthetic Infiltration with ropivacaine after laparoscopic
        abdominal surgery .
  Pain is a natural phenomenon. Pain is an unpleasant sensory and emotional experience
        associated with actual or potential tissue damage. Pain is distressing and detrimental in
        post-operative patients. Management of post-operative pain has been a challenge to
        anesthetists. Pain treatment increase speed of recovery, minimum patient suffering, decrease
        length of stay, reduced hospital costs, increased patient satisfaction, increase productivity
        and quality of life.
  
        Peripheral nerve blockade or field block with local anesthesia is helpful in managing
        postoperative pain effectively whilst avoiding complication associated with intravenous
        narcotics or neuraxial blockade. Regional block will help in reduction of dose and frequency
        of intravenous narcotics used in postoperative period, hence minimizing the side effects of
        narcotics.
  
        Ultrasound guided abdominal nerve blocks are increasingly being used for anaesthesia and
        analgesia. The Transversus Abdominis Plane (TAP) block is a peripheral nerve block that
        results in anesthesia of the abdominal wall. This plane represents an anatomical potential
        space with nerves leaving the plane to innervate the abdominal muscles and skin. Transversus
        abdominis plane block (TAP block) is a novel procedure to provide postoperative analgesia
        following laparoscopic surgery.
  
        Ropivacaine has a greater degree of motor sensory differentiation. Ropivacaine has been
        safely used up to the dose of 200 mg (100 ml of 0.2% ropivacaine) as a field block for post
        operative analgesia. We are giving a larger volume of ropivacaine (20 ml on each side)
        expecting to cover the upper abdomen when TAP block is performed via posterior approach.
  
        NULL HYPOTHESIS There is no difference in post operative analgesia with Transversus Abdominis
        Plane block and local anesthetic infiltration after laparoscopicabdominal surgery
  
        General objective
  
        1. To compare the efficacy of Transversus Abdominal plane block and local anesthetic
        infiltration after laparoscopic abdominal surgery
  
        Specific objective
  
          1. To compare the visual analog score (VAS) between two groups
  
          2. To compare time to first analgesic requirement between two groups.
  
          3. To compare the total dose of analgesia in 24 hours between the two groups
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
  primary purpose: Supportive Care
  masking: Double (Participant, Care Provider)
  masking description: Patients were randomly assigned to two groups having 50patients in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesia assistant who was not involved in the study.
  measure: Duration of analgesia
  time frame: Time Frame: upto first 24 hour after intervention
  description: Visual analog scale at rest
  measure: Duration of analgesia
  time frame: Time Frame: upto first 24 hour after intervention
  description: Visual analog scale on movement
  measure: Time to first rescue analgesia
  time frame: Time Frame: upto first 24 hour after intervention
  description: The time of first complaint of pain by the patient.
  measure: Total pethidine consumption
  time frame: Time Frame: upto first 24 hour after intervention
  description: At any point of time when VAS was>3, injection pethidine 0.5 mg/kg and injection promethazine 0.25 mg/kg was given via intravenous route
  measure: Total ketorolac consumption
  time frame: Time Frame: upto first 24 hour after intervention
  description: When pain persisted for more than 15 min after giving intravenous pethidine, injection ketorolac 30 mg intravenous was given
  arm group label: Group I
  arm group type: Experimental
  description: Transversus Abdominis Plane block
  arm group label: Group II
  arm group type: Experimental
  description: Local infiltration
  intervention type: Drug
  intervention name: Ropivacaine in Transversus abdominis plane
  description: This group received 20ml of Ropivacaine 0.2% Injectable Solution in bilateral transversus abdominis plane at the end of surgery
  arm group label: Group I
  intervention type: Drug
  intervention name: Ropivacaine in Local infiltration at port site
  description: This group received local infiltration of 20ml of Ropivacaine 0.2% Injectable Solutionat port sites at the end of surgery
  arm group label: Group II
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Surendra Bhusal, MD
  role: Principal Investigator
  affiliation: NAMS Bir Hospital
  last name: Brihaspati K C, MD
  role: Study Director
  affiliation: NAMS Bir Hospital
  last name: Kaushal Tamang, MD
  role: Study Chair
  affiliation: NAMS Bir Hospital
  facility: 
  country: Nepal
  responsible party type: Principal Investigator
  investigator affiliation: National Academy of Medical Sciences, Nepal
  investigator full name: Surendra Bhusal
  investigator title: Principal Investigator
  mesh term: Agnosia
  mesh term: Ropivacaine