<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/NCT03229668</url>
  </required_header>
  <id_info>
    <org_study_id>CRBD urologic operations</org_study_id>
    <nct_id>NCT03229668</nct_id>
  </id_info>
  <brief_title>Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations</brief_title>
  <official_title>Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint Savvas Anticancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Thessaly</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Saint Savvas Anticancer Hospital</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 aim of this study is to assess the effect of pregabalin administration on&#xD;
      catheter-related bladder discomfort (CRBD). The study group includes patients that are about&#xD;
      to be subjected to urological operations because of the high incidence of CRBD observed in&#xD;
      this kind of surgical population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prospective, double-blind,randomized, placebo controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration</measure>
    <time_frame>Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively</time_frame>
    <description>Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)</measure>
    <time_frame>Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively</time_frame>
    <description>The goal is to achieve pain scores&lt;3 as these are assessed by the NPRS scale. In order to achieve that we will record the total amount of milligrams of analogues of morphine administered in the first 24 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of the drug</measure>
    <time_frame>All adverse effects observed in the first 24 hours postoperatively</time_frame>
    <description>Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of postoperative sedation</measure>
    <time_frame>In the operating theatre immediately after patient's extubation</time_frame>
    <description>The Ramsay Sedation Scale is used to measure different levels of sedation in medical patients (1=Patient is anxious and agitated or restless, or both 2=Patient is co-operative, oriented, and tranquil, 3=Patient responds to commands only, 4=Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5=Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6=Patient exhibits no response)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Pregabalin on Catheter Related Bladder Discomfort</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of a placebo capsule 1 hour prior to the surgical operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 75mg of pregabalin 1 hour prior to the surgical operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of 150mg of pregabalin 1 hour prior to the surgical operation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo oral capsule administered 1 hour prior to the surgical operation</description>
    <arm_group_label>Group I</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin Oral Capsule [Lyrica] 75mg</intervention_name>
    <description>Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation</description>
    <arm_group_label>Group II</arm_group_label>
    <other_name>Pregabalin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin Oral Capsule [Lyrica] 150 mg</intervention_name>
    <description>Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation</description>
    <arm_group_label>Group III</arm_group_label>
    <other_name>Pregabalin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients about to be subjected to urinary operations&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology&#xD;
&#xD;
          -  History of overactive ((urinary frequency&gt;3 times at night and &gt;8 times in 24 hours),&#xD;
             neurogenic bladder&#xD;
&#xD;
          -  End stage renal failure&#xD;
&#xD;
          -  Central nervous system dysfunction&#xD;
&#xD;
          -  Mental illness/ substance abuse&#xD;
&#xD;
          -  Sensitivity to pregabalin&#xD;
&#xD;
          -  Preoperative administration of pregabalin for other indications&#xD;
&#xD;
          -  Recent bladder catheterization &lt;3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eleni Arnaoutoglou, Prof Of Anesthesiology</last_name>
    <role>Study Chair</role>
    <affiliation>University of Thessaly, Medical School, Anesthesiology Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anticancer Hospital of Athens &quot;Saint Savvas&quot;</name>
      <address>
        <city>Athens</city>
        <zip>115 22</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Thessaly, Medical School</name>
      <address>
        <city>Volos</city>
        <zip>38221</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.</citation>
    <PMID>16415311</PMID>
  </reference>
  <reference>
    <citation>Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.</citation>
    <PMID>25200037</PMID>
  </reference>
  <reference>
    <citation>Tauzin-Fin P, Stecken L, Sztark F. [Catheter-related bladder discomfort in post-anaesthesia care unit]. Ann Fr Anesth Reanim. 2012 Jul-Aug;31(7-8):605-8. doi: 10.1016/j.annfar.2012.03.009. Epub 2012 Jun 29. French.</citation>
    <PMID>22749555</PMID>
  </reference>
  <reference>
    <citation>Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.</citation>
    <PMID>25335575</PMID>
  </reference>
  <reference>
    <citation>Ryu JH, Hwang JW, Lee JW, Seo JH, Park HP, Oh AY, Jeon YT, Do SH. Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2013 Dec;111(6):932-7. doi: 10.1093/bja/aet249. Epub 2013 Jul 17.</citation>
    <PMID>23869107</PMID>
  </reference>
  <reference>
    <citation>Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006 May;96(5):587-9. doi: 10.1093/bja/ael048. Epub 2006 Mar 10.</citation>
    <PMID>16531445</PMID>
  </reference>
  <reference>
    <citation>Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.</citation>
    <PMID>18653496</PMID>
  </reference>
  <reference>
    <citation>Nam K, Seo JH, Ryu JH, Oh AY, Lee T, Park HP, Jeon YT, Hwang JW. Randomized, clinical trial on the preventive effects of butylscopolamine on early postoperative catheter-related bladder discomfort. Surgery. 2015 Feb;157(2):396-401. doi: 10.1016/j.surg.2014.05.017. Epub 2014 Oct 8.</citation>
    <PMID>25304838</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>March 28, 2020</last_update_submitted>
  <last_update_submitted_qc>March 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint Savvas Anticancer Hospital</investigator_affiliation>
    <investigator_full_name>Georgia Micha</investigator_full_name>
    <investigator_title>Anesthesiologist,MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>urinary bladder</keyword>
  <keyword>urinary catheters</keyword>
  <keyword>pregabalin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03229668
org study id: CRBD urologic operations
nct id: NCT03229668
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the effect of pregabalin administration on
      catheter-related bladder discomfort (CRBD). The study group includes patients that are about
      to be subjected to urological operations because of the high incidence of CRBD observed in
      this kind of surgical population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, double-blind,randomized, placebo controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
description: Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)
measure: Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)
time frame: Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively
description: The goal is to achieve pain scores<3 as these are assessed by the NPRS scale. In order to achieve that we will record the total amount of milligrams of analogues of morphine administered in the first 24 hours postoperatively
measure: Adverse effects of the drug
time frame: All adverse effects observed in the first 24 hours postoperatively
description: Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness
measure: Assessment of postoperative sedation
time frame: In the operating theatre immediately after patient's extubation
description: The Ramsay Sedation Scale is used to measure different levels of sedation in medical patients (1=Patient is anxious and agitated or restless, or both 2=Patient is co-operative, oriented, and tranquil, 3=Patient responds to commands only, 4=Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5=Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6=Patient exhibits no response)
arm group label: Group I
arm group type: Placebo Comparator
description: Administration of a placebo capsule 1 hour prior to the surgical operation
arm group label: Group II
arm group type: Experimental
description: Administration of 75mg of pregabalin 1 hour prior to the surgical operation
arm group label: Group III
arm group type: Experimental
description: Administration of 150mg of pregabalin 1 hour prior to the surgical operation
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo oral capsule administered 1 hour prior to the surgical operation
arm group label: Group I
intervention type: Drug
intervention name: Pregabalin Oral Capsule [Lyrica] 75mg
description: Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation
arm group label: Group II
other name: Pregabalin
intervention type: Drug
intervention name: Pregabalin Oral Capsule [Lyrica] 150 mg
description: Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation
arm group label: Group III
other name: Pregabalin
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Eleni Arnaoutoglou, Prof Of Anesthesiology
role: Study Chair
affiliation: University of Thessaly, Medical School, Anesthesiology Clinic
facility: 
facility: 
country: Greece
citation: Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
PMID: 16415311
citation: Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.
PMID: 25200037
citation: Tauzin-Fin P, Stecken L, Sztark F. [Catheter-related bladder discomfort in post-anaesthesia care unit]. Ann Fr Anesth Reanim. 2012 Jul-Aug;31(7-8):605-8. doi: 10.1016/j.annfar.2012.03.009. Epub 2012 Jun 29. French.
PMID: 22749555
citation: Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.
PMID: 25335575
citation: Ryu JH, Hwang JW, Lee JW, Seo JH, Park HP, Oh AY, Jeon YT, Do SH. Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2013 Dec;111(6):932-7. doi: 10.1093/bja/aet249. Epub 2013 Jul 17.
PMID: 23869107
citation: Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006 May;96(5):587-9. doi: 10.1093/bja/ael048. Epub 2006 Mar 10.
PMID: 16531445
citation: Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.
PMID: 18653496
citation: Nam K, Seo JH, Ryu JH, Oh AY, Lee T, Park HP, Jeon YT, Hwang JW. Randomized, clinical trial on the preventive effects of butylscopolamine on early postoperative catheter-related bladder discomfort. Surgery. 2015 Feb;157(2):396-401. doi: 10.1016/j.surg.2014.05.017. Epub 2014 Oct 8.
PMID: 25304838
responsible party type: Principal Investigator
investigator affiliation: Saint Savvas Anticancer Hospital
investigator full name: Georgia Micha
investigator title: Anesthesiologist,MD, MSc, PhD
mesh term: Pregabalin
sharing ipd: Undecided