<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/NCT03228797</url>
  </required_header>
  <id_info>
    <org_study_id>MRC-09/2014_07</org_study_id>
    <nct_id>NCT03228797</nct_id>
  </id_info>
  <brief_title>A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Rectus Sheath Block for Midline Emergency Laparotomy</brief_title>
  <official_title>A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Transversus Abdominis Plane Block for Abdominoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Manar Mamdouh Fahmy Elsharkawi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dubai Health Authority</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      aim of this study is to compare the postoperative analgesia provided bya continuous&#xD;
      preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency&#xD;
      laparotomy.&#xD;
&#xD;
      anticoagulated patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and Methods:&#xD;
&#xD;
      This randomized prospective study will be carried out after the approval of Rashid Hospital's&#xD;
      Research Ethical Committee and patient's written informed consent.&#xD;
&#xD;
      Sixty adult patients , of both gender , 18-70 years old, ASA I-III who will be scheduled for&#xD;
      emergency laparotomy with upper abdominal midline incision will be included in the study.&#xD;
      Exclusion criteria will be patients with known allergic response or contraindications to&#xD;
      paracetamol, parecoxib, morphine or ropivacaine and pregnant women&#xD;
&#xD;
      The enrolled patients will be randomly assigned to one of three groups:&#xD;
&#xD;
      Group I ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of&#xD;
      the surgery using 15 ml ropivacaine 0.5% on either side.&#xD;
&#xD;
      Group II ( 20 patients) for whom a 7.5 , 15 , 30 cm 19-gauge multiholed catheter will be&#xD;
      inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm&#xD;
      away from the lower end of the surgical incision through an introducer peel-away needle. The&#xD;
      length of the catheter will be established to guarantee homogenous distribution of the holes&#xD;
      all along the length of the incision of the fascia. The catheter will be allocated above the&#xD;
      peritoneum within the musculofascial layer and secured to the skin with an occlusive&#xD;
      transparent dressing. A 10 ml bolus of ropivacaine 0.2% will be administered through the&#xD;
      catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of&#xD;
      ropivacaine 10 ml/h.&#xD;
&#xD;
      Group III( 20 patients) a multiholed catheter will be inserted as in Group II and will&#xD;
      receive also an ultrasound guided rectus sheath block as described for Group I.&#xD;
&#xD;
      No premedication will be administered. General anesthesia will be induced using target&#xD;
      controlled intravenous infusion (TCI) using remifentanil (1-10 ng/ml effect concentration )&#xD;
      and propofol ( 1-10 mcg/ml effect concentration) titrated to Bi-spectral index (BIS) value&#xD;
      between 40-60.Once anesthesia level will be reached , succinyl choline 1mg/kg intravenously&#xD;
      will be given. After the airway will be secured , TCI will be adjusted to maintain BIS value&#xD;
      between 40 to 60.An initial dose of 0.1 mg/kg intravenous cisatracurium will be administered&#xD;
      and further doses will be given according to neuromuscular monitoring maintaining a train of&#xD;
      four (TOF) value of zero.&#xD;
&#xD;
      Pre-incision , all patients will receive 15 mg/kg intravenous bolus and 40 mg intravenous&#xD;
      parecoxib. 0.5 mg intravenous ketamine will be administered to avoid remifentanil's induced&#xD;
      hyperalgesia.&#xD;
&#xD;
      All patients will be mechanically ventilated to maintain normocapnia throughout the&#xD;
      procedure. Standard intraoperative monitoring will include electrocardiography, pulse&#xD;
      oximetry , automatic non-invasive blood pressure , end tidal capnography , Bi-spectral index&#xD;
      and train of four monitoring.&#xD;
&#xD;
      At the end of surgery and before extubation , patients who will be randomly assigned to Group&#xD;
      I will receive an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine&#xD;
      0.5% on each side.&#xD;
&#xD;
      For patients who will be assigned to either Group II or Group III , a 7.5 , 15 or 30 cm&#xD;
      19-gauge multiholed catheter will be inserted by the operating surgeon at the end of surgery&#xD;
      and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the&#xD;
      surgical incision through an introducer peel-away needle. The length of the catheter will be&#xD;
      established to guarantee homogenous distribution of the holes all along the length of the&#xD;
      incision of the fascia. The catheter will be allocated above the peritoneum within the&#xD;
      musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 ml&#xD;
      bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an&#xD;
      elastomeric pump delivering a continuous fixed -rate of ropivacaine 10 ml/h.&#xD;
&#xD;
      For patients who will be assigned to Group III will receive also an ultrasound-guided&#xD;
      bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side.&#xD;
&#xD;
      Then the patients will be extubated and shifted to Post-Anesthesia Care Unit (PACU) where&#xD;
      they will be monitored for heart rate , blood pressure , oxygen saturation by pulse oximetry&#xD;
      and pain score using visual analogue scale (VAS) both at rest and deep breathing . These data&#xD;
      will be recorded every 15 minutes for the first hour.&#xD;
&#xD;
      After one hour , the patients will be discharged from PACU according to Modified Aldrete&#xD;
      Scoring if they will reach a score of 9 or more. All patients will receive parecoxib 40 mg&#xD;
      intravenously twice a day and paracetamol in a dose of 40 mg/kg intravenously in three&#xD;
      divided doses regularly for 48 hours postoperatively.&#xD;
&#xD;
      In the postoperative period, all the patients will be evaluated for their hemodynamic&#xD;
      variables ( heart rate , respiratory rate , arterial blood pressure and arterial oxygen&#xD;
      saturation ) and postoperative analgesia using VAS at rest and with deep breathing at&#xD;
      2,4,8,12,18,24,36 and 48 hours postoperatively.&#xD;
&#xD;
      If the patient's VAS will reach 4 at any time in the 48 hours postoperatively, 0.1 mg/kg&#xD;
      titrated intravenous morphine rescue analgesia will be administered and repeated if required&#xD;
      to maintain VAS less than 4.&#xD;
&#xD;
      All patients will respond to a quality of life questionnaire (QR 40) at 24 and 48 hours&#xD;
      postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>comparative study between 3 groups using ropivacaine</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days</measure>
    <time_frame>2 days</time_frame>
    <description>each item is scored (0-10)0=no pain&amp; 10= the worst</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>( 20 patients) multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer, a10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 5ml/h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>an ultrasound guided rectus sheath block</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <other_name>naropine 0.5%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>multiholed catheter</intervention_name>
    <description>gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision</description>
    <arm_group_label>Group II</arm_group_label>
    <other_name>naropine 0.2%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>an ultrasound guided rectus sheath block &amp;multiholed catheter</intervention_name>
    <description>a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.</description>
    <arm_group_label>Group III</arm_group_label>
    <other_name>naropine 0.5% &amp; naropine/ropivacaine 0.2%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA-1 to ASA-3,emergency midline laparotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA-4 &amp; above,allergic patients to the study's medications ,morbid obeses&#xD;
             patients,patient refusal,age below 18yrs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DR.HANY GREISS, consultant</last_name>
    <role>Principal Investigator</role>
    <affiliation>DHA -Rashid hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DR.MANAR MAMADOUH, specialist</last_name>
    <role>Principal Investigator</role>
    <affiliation>DHA -Rashid hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DR.MANSOUR NADHRI, consultant</last_name>
    <role>Study Director</role>
    <affiliation>DHA -Rashid hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DR.OSAMA ALANI, senior specialist</last_name>
    <role>Study Director</role>
    <affiliation>DHA -Rashid hospital</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dubai Health Authority</investigator_affiliation>
    <investigator_full_name>Dr Manar Mamdouh Fahmy Elsharkawi</investigator_full_name>
    <investigator_title>anaesthesiologist</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 11, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03228797/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03228797
org study id: MRC-09/2014_07
nct id: NCT03228797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
aim of this study is to compare the postoperative analgesia provided bya continuous
      preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency
      laparotomy.

      anticoagulated patients
Patients and Methods:

      This randomized prospective study will be carried out after the approval of Rashid Hospital's
      Research Ethical Committee and patient's written informed consent.

      Sixty adult patients , of both gender , 18-70 years old, ASA I-III who will be scheduled for
      emergency laparotomy with upper abdominal midline incision will be included in the study.
      Exclusion criteria will be patients with known allergic response or contraindications to
      paracetamol, parecoxib, morphine or ropivacaine and pregnant women

      The enrolled patients will be randomly assigned to one of three groups:

      Group I ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of
      the surgery using 15 ml ropivacaine 0.5% on either side.

      Group II ( 20 patients) for whom a 7.5 , 15 , 30 cm 19-gauge multiholed catheter will be
      inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm
      away from the lower end of the surgical incision through an introducer peel-away needle. The
      length of the catheter will be established to guarantee homogenous distribution of the holes
      all along the length of the incision of the fascia. The catheter will be allocated above the
      peritoneum within the musculofascial layer and secured to the skin with an occlusive
      transparent dressing. A 10 ml bolus of ropivacaine 0.2% will be administered through the
      catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of
      ropivacaine 10 ml/h.

      Group III( 20 patients) a multiholed catheter will be inserted as in Group II and will
      receive also an ultrasound guided rectus sheath block as described for Group I.

      No premedication will be administered. General anesthesia will be induced using target
      controlled intravenous infusion (TCI) using remifentanil (1-10 ng/ml effect concentration )
      and propofol ( 1-10 mcg/ml effect concentration) titrated to Bi-spectral index (BIS) value
      between 40-60.Once anesthesia level will be reached , succinyl choline 1mg/kg intravenously
      will be given. After the airway will be secured , TCI will be adjusted to maintain BIS value
      between 40 to 60.An initial dose of 0.1 mg/kg intravenous cisatracurium will be administered
      and further doses will be given according to neuromuscular monitoring maintaining a train of
      four (TOF) value of zero.

      Pre-incision , all patients will receive 15 mg/kg intravenous bolus and 40 mg intravenous
      parecoxib. 0.5 mg intravenous ketamine will be administered to avoid remifentanil's induced
      hyperalgesia.

      All patients will be mechanically ventilated to maintain normocapnia throughout the
      procedure. Standard intraoperative monitoring will include electrocardiography, pulse
      oximetry , automatic non-invasive blood pressure , end tidal capnography , Bi-spectral index
      and train of four monitoring.

      At the end of surgery and before extubation , patients who will be randomly assigned to Group
      I will receive an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine
      0.5% on each side.

      For patients who will be assigned to either Group II or Group III , a 7.5 , 15 or 30 cm
      19-gauge multiholed catheter will be inserted by the operating surgeon at the end of surgery
      and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the
      surgical incision through an introducer peel-away needle. The length of the catheter will be
      established to guarantee homogenous distribution of the holes all along the length of the
      incision of the fascia. The catheter will be allocated above the peritoneum within the
      musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 ml
      bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an
      elastomeric pump delivering a continuous fixed -rate of ropivacaine 10 ml/h.

      For patients who will be assigned to Group III will receive also an ultrasound-guided
      bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side.

      Then the patients will be extubated and shifted to Post-Anesthesia Care Unit (PACU) where
      they will be monitored for heart rate , blood pressure , oxygen saturation by pulse oximetry
      and pain score using visual analogue scale (VAS) both at rest and deep breathing . These data
      will be recorded every 15 minutes for the first hour.

      After one hour , the patients will be discharged from PACU according to Modified Aldrete
      Scoring if they will reach a score of 9 or more. All patients will receive parecoxib 40 mg
      intravenously twice a day and paracetamol in a dose of 40 mg/kg intravenously in three
      divided doses regularly for 48 hours postoperatively.

      In the postoperative period, all the patients will be evaluated for their hemodynamic
      variables ( heart rate , respiratory rate , arterial blood pressure and arterial oxygen
      saturation ) and postoperative analgesia using VAS at rest and with deep breathing at
      2,4,8,12,18,24,36 and 48 hours postoperatively.

      If the patient's VAS will reach 4 at any time in the 48 hours postoperatively, 0.1 mg/kg
      titrated intravenous morphine rescue analgesia will be administered and repeated if required
      to maintain VAS less than 4.

      All patients will respond to a quality of life questionnaire (QR 40) at 24 and 48 hours
      postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: comparative study between 3 groups using ropivacaine
primary purpose: Supportive Care
masking: None (Open Label)
measure: self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days
time frame: 2 days
description: each item is scored (0-10)0=no pain& 10= the worst
arm group label: Group I
arm group type: Active Comparator
description: ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.
arm group label: Group II
arm group type: Active Comparator
description: ( 20 patients) multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer, a10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 5ml/h.
arm group label: Group III
arm group type: Active Comparator
description: ( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.
intervention type: Procedure
intervention name: an ultrasound guided rectus sheath block
arm group label: Group I
other name: naropine 0.5%
intervention type: Procedure
intervention name: multiholed catheter
description: gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision
arm group label: Group II
other name: naropine 0.2%
intervention type: Procedure
intervention name: an ultrasound guided rectus sheath block &multiholed catheter
description: a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.
arm group label: Group III
other name: naropine 0.5% & naropine/ropivacaine 0.2%
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: DR.HANY GREISS, consultant
role: Principal Investigator
affiliation: DHA -Rashid hospital
last name: DR.MANAR MAMADOUH, specialist
role: Principal Investigator
affiliation: DHA -Rashid hospital
last name: DR.MANSOUR NADHRI, consultant
role: Study Director
affiliation: DHA -Rashid hospital
last name: DR.OSAMA ALANI, senior specialist
role: Study Director
affiliation: DHA -Rashid hospital
responsible party type: Sponsor-Investigator
investigator affiliation: Dubai Health Authority
investigator full name: Dr Manar Mamdouh Fahmy Elsharkawi
investigator title: anaesthesiologist
mesh term: Abdominal Pain
mesh term: Ropivacaine
sharing ipd: Undecided
provided document: 