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/NCT06039423</url>
    </required_header>
    <id_info>
      <org_study_id>0306061</org_study_id>
      <nct_id>NCT06039423</nct_id>
    </id_info>
    <brief_title>Modified Thoracoabdominal Nerves Block Through Perichondrial Approach: a New Strategy With a Wide Range of Utilization in Laparoscopic Gynecological Surgeries.</brief_title>
    <official_title>Modified Thoracoabdominal Nerves Block Through Perichondrial Approach: a New Strategy With a Wide Range of Utilization in Laparoscopic Gynecological Surgeries.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</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 current study was to assess the analgesic effects of the modified thoracoabdominal nerves&#xD;
        block through perichondrial approach (M-TAPA) block in patients undergoing gynecological&#xD;
        laparoscopic surgeries.The primary goal was to evaluate the analgesic efficacy of M-TAPA&#xD;
        block accomplished prior to surgery in patients undergoing Laparoscopic gynecological&#xD;
        surgeries&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients were thoroughly assessed preoperatively by history evaluation as regards current&#xD;
        medical condition and drug therapy, careful clinical examination and laboratory evaluations&#xD;
        (complete blood picture, liver function and renal function tests). Explanation of the&#xD;
        anaesthesia method was done to all patients and they were instructed wisely on how to utilize&#xD;
        the 10 cm linear visual Analogue scale (VAS), with (0) denoting pain free state, whereas (10)&#xD;
        stands for the worst intractable pain [9]. Fifteen minutes before induction, all patients&#xD;
        were premedicated with i.v. midazolam 0.03 mg kg-1 In the operating room, an i.v. cannula was&#xD;
        placed and secured, then standard monitoring including (pulse oximetry, ECG, non- invasive&#xD;
        blood pressure and end tidal carbon dioxide) were applied to each patient using multichannel&#xD;
        (Datex ohmeda S/5, Germany) monitor. Anaesthesia was induced with lidocaine (1mg/kg) followed&#xD;
        by (1.5 - 2 mg/kg) propofol -till cessation of verbal contact- and (1-1.5 μg/kg) fentanyl.&#xD;
        Endotracheal intubation was accomplished with rocuronium (1mg/kg) and a suitable sized tube.&#xD;
        Anaesthesia was maintained with sevoflurane (1-2 %) with (50 %) oxygen in air. Controlled&#xD;
        mechanical ventilation was provided to maintain ETCO2 between (33-35 mmHg) and an oxygen&#xD;
        saturation of 98 %.&#xD;
  &#xD;
        Patients will be randomly assigned- using closed envelope technique- into 2 groups (30&#xD;
        patient) each:&#xD;
  &#xD;
        Group (M): The M-TAPA block will be combined with general anaesthesia. Group (C): (control&#xD;
        group) conventional general anaesthesia receiving multimodal analgesia.&#xD;
  &#xD;
        In group (M), after the induction of anaesthesia and with the patient in the supine position,&#xD;
        the block was performed before starting of the surgical procedure as described by Tulgar et&#xD;
        al. [8]. After surgical skin disinfection with 10 % povidone-iodine, it was covered with&#xD;
        sterile surgical fenestrated drapes. A high frequency (6-12 MHz) US linear probe (Fujifilm&#xD;
        Sonosite, Tokyo, Japan) covered with a sterile cover was placed in the sagittal plane on the&#xD;
        10 th costal margin in the midline. The probe was then angulated deeply to visualize the&#xD;
        lower surface of the costal cartilage. Via in plane technique, a 21 gauge Tuohy needle&#xD;
        (Stimuplex B-Braun Medical, Melsungen, Germany) was inserted cranially between the lower&#xD;
        fascia of the costal cartilage and upper fascia of the transversus abdominis muscle by moving&#xD;
        the needle tip towards the posterior aspect of the 10 th costal cartilage with caution not to&#xD;
        cross the cranial edge of the 10th costal cartilage and 20 mL of bupivacaine (0.25 %) was&#xD;
        injected bilaterally, in the midclavicular line.&#xD;
  &#xD;
        In group (C), ketorolac 0.75 mg/kg and paracetamol 10 mg/kg were administered intravenously&#xD;
        before surgical stimulus.&#xD;
  &#xD;
        Inadequate analgesia expressed in the form of elevated blood pressure or accelerated heart&#xD;
        rate 20 % above baseline value was managed by administration of 0.5 (μg/kg) fentanyl bolus as&#xD;
        a rescue analgesia. Perioperative hypothermia was managed by warming of i.v fluids and forced&#xD;
        air warming to exposed areas. Precise fluid replacement was provided to all subjects&#xD;
        according to the standard guidelines applied during anaesthesia.&#xD;
  &#xD;
        At the end of surgery, sevoflurane vaporizer was shut off followed by administration of 100 %&#xD;
        oxygen. Muscle relaxant was reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg&#xD;
        slowly i.v, after oropharyngeal secretions were suctioned. The tube was removed after&#xD;
        ensuring that the patients regained consciousness, breathed spontaneously and respond to&#xD;
        verbal command. IV ondansetron (8) mg was given to all patients to guard against&#xD;
        postoperative nausea and vomiting.&#xD;
  &#xD;
        Patients were transferred to the PACU, where monitoring of heart rate, arterial blood&#xD;
        pressure, respiration, and temperature were done by recovery nurses unaware to the study&#xD;
        design to avoid bias. Postoperative analgesia was administrated with paracetamol i.v. 1 gm/8&#xD;
        hr throughout the first 24 hours postoperatively and standardized intravenous&#xD;
        patient-controlled analgesia (IV-PCA) with morphine (0.5 mg/mL, 2-mg bolus, lock-out period&#xD;
        10 mins, and 4 hrs limit of 20 mg) based on reaching the score of ≥ (4) VAS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 2, 2023</start_date>
    <completion_date type="Actual">September 7, 2023</completion_date>
    <primary_completion_date type="Actual">August 15, 2023</primary_completion_date>
    <phase>Phase 2</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>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Total dose of fentanyl consumption</measure>
      <time_frame>after 1 hour postoperative</time_frame>
      <description>analgesic efficacy of M-TAPA block</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative morphine given (mg) in the first 24 hrs</measure>
      <time_frame>after 24 hours postoperatively</time_frame>
      <description>analgesic efficacyof M-TAPA block</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Analgesic Efficacy of M-TAPA Block Accomplished Prior to Surgery in Patients Undergoing Laparoscopic Gynecological Surgeries</condition>
    <arm_group>
      <arm_group_label>Group (M)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The M-TAPA block will be combined with general anaesthesia.&#xD;
  :</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (C)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>(control group) conventional general anaesthesia receiving multimodal analgesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>The M-TAPA block</intervention_name>
      <description>A high frequency (6-12 MHz) US linear probe was placed in the sagittal plane on the 10 th costal margin in the midline. The probe was then angulated deeply to visualize the lower surface of the costal cartilage. Via in plane technique, a 21 gauge Tuohy needle was inserted cranially between the lower fascia of the costal cartilage and upper fascia of the transversus abdominis muscle by moving the needle tip towards the posterior aspect of the 10 th costal cartilage and 20 mL bupivacaine (0.25 %) was injected.</description>
      <arm_group_label>Group (M)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketorolac</intervention_name>
      <description>conventional general anaesthesia receiving multimodal analgesia</description>
      <arm_group_label>Group (C)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult female patients&#xD;
  &#xD;
            -  aged 20-65 years,&#xD;
  &#xD;
            -  normal coagulation profile,&#xD;
  &#xD;
            -  scheduled for ambulatory laparoscopic gynecological surgeries under general&#xD;
               anaesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient refusal,&#xD;
  &#xD;
            -  skin infection at the site of the needle puncture&#xD;
  &#xD;
            -  known allergies to any of the study medications&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alexandria University Faculty of Medicin</name>
        <address>
          <city>Alexandria</city>
          <zip>21615</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketorolac</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/NCT06039423
  org study id: 0306061
  nct id: NCT06039423
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The current study was to assess the analgesic effects of the modified thoracoabdominal nerves
        block through perichondrial approach (M-TAPA) block in patients undergoing gynecological
        laparoscopic surgeries.The primary goal was to evaluate the analgesic efficacy of M-TAPA
        block accomplished prior to surgery in patients undergoing Laparoscopic gynecological
        surgeries
  All patients were thoroughly assessed preoperatively by history evaluation as regards current
        medical condition and drug therapy, careful clinical examination and laboratory evaluations
        (complete blood picture, liver function and renal function tests). Explanation of the
        anaesthesia method was done to all patients and they were instructed wisely on how to utilize
        the 10 cm linear visual Analogue scale (VAS), with (0) denoting pain free state, whereas (10)
        stands for the worst intractable pain [9]. Fifteen minutes before induction, all patients
        were premedicated with i.v. midazolam 0.03 mg kg-1 In the operating room, an i.v. cannula was
        placed and secured, then standard monitoring including (pulse oximetry, ECG, non- invasive
        blood pressure and end tidal carbon dioxide) were applied to each patient using multichannel
        (Datex ohmeda S/5, Germany) monitor. Anaesthesia was induced with lidocaine (1mg/kg) followed
        by (1.5 - 2 mg/kg) propofol -till cessation of verbal contact- and (1-1.5 μg/kg) fentanyl.
        Endotracheal intubation was accomplished with rocuronium (1mg/kg) and a suitable sized tube.
        Anaesthesia was maintained with sevoflurane (1-2 %) with (50 %) oxygen in air. Controlled
        mechanical ventilation was provided to maintain ETCO2 between (33-35 mmHg) and an oxygen
        saturation of 98 %.
  
        Patients will be randomly assigned- using closed envelope technique- into 2 groups (30
        patient) each:
  
        Group (M): The M-TAPA block will be combined with general anaesthesia. Group (C): (control
        group) conventional general anaesthesia receiving multimodal analgesia.
  
        In group (M), after the induction of anaesthesia and with the patient in the supine position,
        the block was performed before starting of the surgical procedure as described by Tulgar et
        al. [8]. After surgical skin disinfection with 10 % povidone-iodine, it was covered with
        sterile surgical fenestrated drapes. A high frequency (6-12 MHz) US linear probe (Fujifilm
        Sonosite, Tokyo, Japan) covered with a sterile cover was placed in the sagittal plane on the
        10 th costal margin in the midline. The probe was then angulated deeply to visualize the
        lower surface of the costal cartilage. Via in plane technique, a 21 gauge Tuohy needle
        (Stimuplex B-Braun Medical, Melsungen, Germany) was inserted cranially between the lower
        fascia of the costal cartilage and upper fascia of the transversus abdominis muscle by moving
        the needle tip towards the posterior aspect of the 10 th costal cartilage with caution not to
        cross the cranial edge of the 10th costal cartilage and 20 mL of bupivacaine (0.25 %) was
        injected bilaterally, in the midclavicular line.
  
        In group (C), ketorolac 0.75 mg/kg and paracetamol 10 mg/kg were administered intravenously
        before surgical stimulus.
  
        Inadequate analgesia expressed in the form of elevated blood pressure or accelerated heart
        rate 20 % above baseline value was managed by administration of 0.5 (μg/kg) fentanyl bolus as
        a rescue analgesia. Perioperative hypothermia was managed by warming of i.v fluids and forced
        air warming to exposed areas. Precise fluid replacement was provided to all subjects
        according to the standard guidelines applied during anaesthesia.
  
        At the end of surgery, sevoflurane vaporizer was shut off followed by administration of 100 %
        oxygen. Muscle relaxant was reversed with neostigmine 0.04 mg/kg and atropine 0.02 mg/kg
        slowly i.v, after oropharyngeal secretions were suctioned. The tube was removed after
        ensuring that the patients regained consciousness, breathed spontaneously and respond to
        verbal command. IV ondansetron (8) mg was given to all patients to guard against
        postoperative nausea and vomiting.
  
        Patients were transferred to the PACU, where monitoring of heart rate, arterial blood
        pressure, respiration, and temperature were done by recovery nurses unaware to the study
        design to avoid bias. Postoperative analgesia was administrated with paracetamol i.v. 1 gm/8
        hr throughout the first 24 hours postoperatively and standardized intravenous
        patient-controlled analgesia (IV-PCA) with morphine (0.5 mg/mL, 2-mg bolus, lock-out period
        10 mins, and 4 hrs limit of 20 mg) based on reaching the score of ≥ (4) VAS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Total dose of fentanyl consumption
  time frame: after 1 hour postoperative
  description: analgesic efficacy of M-TAPA block
  measure: postoperative morphine given (mg) in the first 24 hrs
  time frame: after 24 hours postoperatively
  description: analgesic efficacyof M-TAPA block
  arm group label: Group (M)
  arm group type: Active Comparator
  description: The M-TAPA block will be combined with general anaesthesia.
  :
  arm group label: Group (C)
  arm group type: Placebo Comparator
  description: (control group) conventional general anaesthesia receiving multimodal analgesia.
  intervention type: Procedure
  intervention name: The M-TAPA block
  description: A high frequency (6-12 MHz) US linear probe was placed in the sagittal plane on the 10 th costal margin in the midline. The probe was then angulated deeply to visualize the lower surface of the costal cartilage. Via in plane technique, a 21 gauge Tuohy needle was inserted cranially between the lower fascia of the costal cartilage and upper fascia of the transversus abdominis muscle by moving the needle tip towards the posterior aspect of the 10 th costal cartilage and 20 mL bupivacaine (0.25 %) was injected.
  arm group label: Group (M)
  intervention type: Drug
  intervention name: Ketorolac
  description: conventional general anaesthesia receiving multimodal analgesia
  arm group label: Group (C)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Ketorolac