<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/NCT01721031</url>
  </required_header>
  <id_info>
    <org_study_id>DPNB120928</org_study_id>
    <secondary_id>LRWCHA</secondary_id>
    <nct_id>NCT01721031</nct_id>
  </id_info>
  <brief_title>DPNB for Prevention of CRDB</brief_title>
  <official_title>Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is&#xD;
      defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may&#xD;
      cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve&#xD;
      block (DPNB) was applied for penile surgery including circumcision and some anterior urethra&#xD;
      surgery. The investigators hypothesize that DPNB relive CRBD for male patients with&#xD;
      indwelling urinary catheter under general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CRBD is not uncommon in the postoperative period, especially in male patients who have had&#xD;
      urinary catheterization after anesthetic induction under general anesthesia, and this symptom&#xD;
      complex may cause patient agitated and exacerbated postoperative pain. According to the&#xD;
      previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in&#xD;
      reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated&#xD;
      with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve&#xD;
      block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect&#xD;
      postoperatively without side effects related to tramadol. Besides, we observed patients&#xD;
      underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if&#xD;
      DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB&#xD;
      for male patient with indwelling urinary catheter insertion after induction of general&#xD;
      anesthesia.&#xD;
&#xD;
      In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33%&#xD;
      ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the&#xD;
      incidences of side effects postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">December 15, 2015</completion_date>
  <primary_completion_date type="Actual">December 1, 2015</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of CRBD</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) for postoperative pain</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative fentanyl requirement</measure>
    <time_frame>up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>up to 6 months</time_frame>
    <description>the level of sedation.&#xD;
postoperative nausea vomiting (PONV)&#xD;
incidence of respiratory depression&#xD;
incidence of agitation, and delirium</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acceptance of indwelling urinary catheter</measure>
    <time_frame>up to 6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Indwelling Urinary Catheter</condition>
  <condition>Male Patients</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>DPNB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive DPNB 30min before extubation at the end of operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tramadol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DPNB</intervention_name>
    <description>Patients receive DPNB 30min before extubation at the end of operation</description>
    <arm_group_label>DPNB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol</intervention_name>
    <description>Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.</description>
    <arm_group_label>Tramadol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Male adult patient, aged 18~50 years old, ASA I~III&#xD;
&#xD;
          -  Surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bladder dysfunction, such as overactive bladder&#xD;
&#xD;
          -  A history of bladder outflow obstruction&#xD;
&#xD;
          -  Prostate disease, such as benign prostate hyperplasia, etc.&#xD;
&#xD;
          -  Disturbance of central nervous system&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 27, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Ren Liao</investigator_full_name>
    <investigator_title>Doctor, Associate professor</investigator_title>
  </responsible_party>
  <keyword>Catheter Related Bladder Discomfort</keyword>
  <keyword>Dorsal Penile Nerve Block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01721031
org study id: DPNB120928
secondary id: LRWCHA
nct id: NCT01721031
lead sponsor: 
has dmc: Yes
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is
      defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may
      cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve
      block (DPNB) was applied for penile surgery including circumcision and some anterior urethra
      surgery. The investigators hypothesize that DPNB relive CRBD for male patients with
      indwelling urinary catheter under general anesthesia.
CRBD is not uncommon in the postoperative period, especially in male patients who have had
      urinary catheterization after anesthetic induction under general anesthesia, and this symptom
      complex may cause patient agitated and exacerbated postoperative pain. According to the
      previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in
      reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated
      with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve
      block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect
      postoperatively without side effects related to tramadol. Besides, we observed patients
      underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if
      DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB
      for male patient with indwelling urinary catheter insertion after induction of general
      anesthesia.

      In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33%
      ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the
      incidences of side effects postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of CRBD
time frame: up to 6 months
measure: Visual analogue scale (VAS) for postoperative pain
time frame: up to 6 months
measure: Postoperative fentanyl requirement
time frame: up to 6 months
measure: Side effects
time frame: up to 6 months
description: the level of sedation.
postoperative nausea vomiting (PONV)
incidence of respiratory depression
incidence of agitation, and delirium
measure: Acceptance of indwelling urinary catheter
time frame: up to 6 months
arm group label: DPNB
arm group type: Experimental
description: Patients receive DPNB 30min before extubation at the end of operation.
arm group label: Tramadol
arm group type: Active Comparator
description: Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
intervention type: Procedure
intervention name: DPNB
description: Patients receive DPNB 30min before extubation at the end of operation
arm group label: DPNB
intervention type: Drug
intervention name: Tramadol
description: Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
arm group label: Tramadol
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Ren Liao
investigator title: Doctor, Associate professor
mesh term: Tramadol