<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/NCT03032458</url>
  </required_header>
  <id_info>
    <org_study_id>MD/16.11.72</org_study_id>
    <nct_id>NCT03032458</nct_id>
  </id_info>
  <brief_title>Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy</brief_title>
  <official_title>Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine&#xD;
      gel as analgesics for pain control in shockwave lithotripsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors&#xD;
      like age, gender, and body habitus moreover, young female patients, anxious and depressed&#xD;
      patients or thin patients experience more pain during SWL.&#xD;
&#xD;
      Several physical variables influencing treatment-related pain have been identified: the type&#xD;
      of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves,&#xD;
      diameter of the focal zone, and size of the aperture of the shockwave source reflecting the&#xD;
      area of shockwave entry at the skin.&#xD;
&#xD;
      Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but&#xD;
      also to facilitate stone imaging and targeting by reducing patients' movements during&#xD;
      successive shock wave impacts. Reduced patient movement enables increase fragmentation&#xD;
      efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative&#xD;
      patient during treatment is paramount in maintaining stone targeting for optimal&#xD;
      fragmentation.&#xD;
&#xD;
      Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in&#xD;
      SWL analgesia practice.&#xD;
&#xD;
      In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that&#xD;
      pain control during SWL is necessary to limit pain induced movements and excessive&#xD;
      respiratory excursions, However no recommendation for proper analgesia in contrast to clear&#xD;
      recommendation for Pain relief in patients with an acute stone episode.&#xD;
&#xD;
      The investigators will try in this trial to identify the best efficacious type of analgesia&#xD;
      for patient during SWL in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain control __ Outcome Measure by &quot;pain assessment scales of The National Initiative on Pain Control™ (NIPC™)&quot;</measure>
    <time_frame>10 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of anxiety on success of SWL __ Outcome Measure by &quot;Generalized Anxiety Disorder 7-item &quot;</measure>
    <time_frame>10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of anxiety on success of SWL __ Outcome Measure by &quot;The Patient Health Questionnaire (PHQ-9)&quot;</measure>
    <time_frame>10 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare stone free rate __ Outcome Measure by &quot;ultrasound and plain x-ray&quot; 1 week after session. If no residual stone, NCCT scan.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Analgesia</condition>
  <condition>Urolithiasis</condition>
  <arm_group>
    <arm_group_label>Pethidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketorolac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Xylocaine Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pethidine</intervention_name>
    <description>pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg</description>
    <arm_group_label>Pethidine</arm_group_label>
    <other_name>Pethidine 50</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.</description>
    <arm_group_label>Ketorolac</arm_group_label>
    <other_name>Ketolac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xylocaine Gel</intervention_name>
    <description>Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then</description>
    <arm_group_label>Xylocaine Gel</arm_group_label>
    <other_name>lidocaine 2%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with renal and upper ureteral stones amenable to SWL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to pethidine.&#xD;
&#xD;
          -  Allergy to Ketorolac.&#xD;
&#xD;
          -  Allergy to Xylocaine gel.&#xD;
&#xD;
          -  American Society of Anesthesiologists score ≥ 3 (ASA III or more).&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients with a pacemaker.&#xD;
&#xD;
          -  Bleeding diatheses.&#xD;
&#xD;
          -  Uncontrolled urinary tract infection (UTI).&#xD;
&#xD;
          -  Severe obesity which prevent targeting of the stone.&#xD;
&#xD;
          -  Body Mass IndexBMI (40 or more)&#xD;
&#xD;
          -  Arterial aneurysm in the vicinity of the stone.&#xD;
&#xD;
          -  Anatomical obstruction distal to the stone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hassan Abol-Enein, MD, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Urology and Nephrology Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology and Nephrology Center</name>
      <address>
        <city>Mansourah</city>
        <state>Aldakahlia</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>May 24, 2018</last_update_submitted>
  <last_update_submitted_qc>May 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Abdelwahab Hashem</investigator_full_name>
    <investigator_title>Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Shock Wave Lithotripsy</keyword>
  <keyword>Ketorolac</keyword>
  <keyword>Xylocaine Gel</keyword>
  <keyword>Pethidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urolithiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Meperidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)</ipd_description>
  </patient_data>
  <!-- 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/NCT03032458
org study id: MD/16.11.72
nct id: NCT03032458
lead sponsor: 
has dmc: Yes
A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine
      gel as analgesics for pain control in shockwave lithotripsy.
Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors
      like age, gender, and body habitus moreover, young female patients, anxious and depressed
      patients or thin patients experience more pain during SWL.

      Several physical variables influencing treatment-related pain have been identified: the type
      of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves,
      diameter of the focal zone, and size of the aperture of the shockwave source reflecting the
      area of shockwave entry at the skin.

      Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but
      also to facilitate stone imaging and targeting by reducing patients' movements during
      successive shock wave impacts. Reduced patient movement enables increase fragmentation
      efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative
      patient during treatment is paramount in maintaining stone targeting for optimal
      fragmentation.

      Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in
      SWL analgesia practice.

      In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that
      pain control during SWL is necessary to limit pain induced movements and excessive
      respiratory excursions, However no recommendation for proper analgesia in contrast to clear
      recommendation for Pain relief in patients with an acute stone episode.

      The investigators will try in this trial to identify the best efficacious type of analgesia
      for patient during SWL in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"
time frame: 10 months
measure: Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "
time frame: 10 months
measure: Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"
time frame: 10 months
measure: Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.
time frame: 1 year
arm group label: Pethidine
arm group type: Active Comparator
description: Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)
arm group label: Ketorolac
arm group type: Active Comparator
description: Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)
arm group label: Xylocaine Gel
arm group type: Active Comparator
description: Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)
intervention type: Drug
intervention name: Pethidine
description: pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg
arm group label: Pethidine
other name: Pethidine 50
intervention type: Drug
intervention name: Ketorolac
description: ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.
arm group label: Ketorolac
other name: Ketolac
intervention type: Drug
intervention name: Xylocaine Gel
description: Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
arm group label: Xylocaine Gel
other name: lidocaine 2%
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Hassan Abol-Enein, MD, Phd
role: Study Chair
affiliation: Urology and Nephrology Center
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Abdelwahab Hashem
investigator title: Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator
mesh term: Urolithiasis
mesh term: Ketorolac
mesh term: Lidocaine
mesh term: Meperidine
sharing ipd: Yes
ipd description: meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair) or Prof. Khaled Z. Sheir, MD ( Study Central Contact Backup)