<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/NCT04470843</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00031299</org_study_id>
    <nct_id>NCT04470843</nct_id>
  </id_info>
  <brief_title>Impact of Acetazolamide in Reducing Referred Postoperative Pain</brief_title>
  <official_title>Impact of Acetazolamide in Reducing Referred Postoperative Pain After Robotic Assisted Laparoscopic Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate&#xD;
      cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves&#xD;
      removing a man's prostate using a minimally invasive robotic approach under the guidance of a&#xD;
      surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the&#xD;
      surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic&#xD;
      procedures because it is cost-effective, noncombustible and readily excreted via the&#xD;
      respiratory system in healthy patients.&#xD;
&#xD;
      Insufflation with CO2, however, has been linked to post-operative referred pain secondary to&#xD;
      peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid&#xD;
      from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred&#xD;
      pain, may not be adequately treated with the current standard pain control regimen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2018</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
  <phase>Phase 1</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>Visual Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain.</measure>
    <time_frame>24 hours</time_frame>
    <description>The primary outcome to be assessed is the absolute change in VAS score both in general and at the shoulder tip. This will be measured as the difference between the VAS score obtained pre-operatively, when first responsive after surgery in the post anesthesia care unit (PACU), immediately prior to leaving PACU, and throughout the hospital stay per standard of care.&#xD;
Δ VAS = Postoperative VAS - Preoperative VAS VAS is a testing technique for measuring subjective or behavioral phenomena (as pain or dietary consumption) in which a subject selects from a gradient of alternatives (as from &quot;no pain&quot; to &quot;worst imaginable pain&quot; or from &quot;every day&quot; to &quot;never&quot;) arranged in linear fashion -abbreviation VAS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Men</condition>
  <arm_group>
    <arm_group_label>Acetazolamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetazolamide</intervention_name>
    <description>Being that adequate pain control is essential to recovery in the post-operative setting, efforts have been made to address this pain at its root. Prior studies have demonstrated that preoperative administration of acetazolamide decreased post-operative referred pain in the immediate post-surgical period.</description>
    <arm_group_label>Acetazolamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Male patients ≥18 years of age undergoing robotic-assisted prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with renal insufficiency with serum creatinine &gt;2.0 mg/dl&#xD;
&#xD;
          -  Patients with renal transplant&#xD;
&#xD;
          -  Patients with pre-existing metabolic acidosis&#xD;
&#xD;
          -  Patients with chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Patients with hepatic disease&#xD;
&#xD;
          -  Patients with central nervous system disorders&#xD;
&#xD;
          -  Patients with hematological disease history&#xD;
&#xD;
          -  Patients with pre-existing electrolyte abnormalities&#xD;
&#xD;
          -  Patients with hypovolemia&#xD;
&#xD;
          -  Patients with lithium or diuretic usage&#xD;
&#xD;
          -  Patients with sulfonamides allergy&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists physical status 4 or 5&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Males having a robotic-assisted prostatectomy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Johnson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert Memorial Lutheran Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 27, 2018</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical College of Wisconsin</investigator_affiliation>
    <investigator_full_name>Scott Johnson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Prostatectomy</keyword>
  <keyword>Acetazolamide</keyword>
  <keyword>Postoperative Pain</keyword>
  <keyword>Prostate Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetazolamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04470843
org study id: PRO00031299
nct id: NCT04470843
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Robotic assisted laparoscopic prostatectomy (RALP) is the standard treatment for prostate
      cancer, due to the benefits of decreased blood loss and length of stay.The procedure involves
      removing a man's prostate using a minimally invasive robotic approach under the guidance of a
      surgeon. In order to gain sufficient access, carbon dioxide (CO2) is used to fill the
      surgical space in a process termed insufflation. Carbon dioxide is a mainstay in laparoscopic
      procedures because it is cost-effective, noncombustible and readily excreted via the
      respiratory system in healthy patients.

      Insufflation with CO2, however, has been linked to post-operative referred pain secondary to
      peritoneal acidosis.This acidosis is suspected to be due to the formation of carbonic acid
      from the CO2 insufflation.Peritoneal acidosis, and its associated post-operative referred
      pain, may not be adequately treated with the current standard pain control regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Visual Analogue Scale (VAS) 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his pain.
time frame: 24 hours
description: The primary outcome to be assessed is the absolute change in VAS score both in general and at the shoulder tip. This will be measured as the difference between the VAS score obtained pre-operatively, when first responsive after surgery in the post anesthesia care unit (PACU), immediately prior to leaving PACU, and throughout the hospital stay per standard of care.
Δ VAS = Postoperative VAS - Preoperative VAS VAS is a testing technique for measuring subjective or behavioral phenomena (as pain or dietary consumption) in which a subject selects from a gradient of alternatives (as from "no pain" to "worst imaginable pain" or from "every day" to "never") arranged in linear fashion -abbreviation VAS
arm group label: Acetazolamide
arm group type: Active Comparator
description: Group 1 (acetazolamide): Patients undergoing RALP with the peri-operative use of one-time 250 mg dose of acetazolamide
arm group label: Placebo
arm group type: Placebo Comparator
description: Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
intervention type: Drug
intervention name: Acetazolamide
description: Being that adequate pain control is essential to recovery in the post-operative setting, efforts have been made to address this pain at its root. Prior studies have demonstrated that preoperative administration of acetazolamide decreased post-operative referred pain in the immediate post-surgical period.
arm group label: Acetazolamide
intervention type: Other
intervention name: Placebo
description: Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
arm group label: Placebo
criteria: 
gender: Male
gender based: Yes
gender description: Males having a robotic-assisted prostatectomy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Johnson, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical College of Wisconsin
investigator full name: Scott Johnson
investigator title: Assistant Professor
mesh term: Prostatic Neoplasms
mesh term: Pain, Postoperative
mesh term: Acetazolamide
sharing ipd: No