<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/NCT04426500</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 19-1532</org_study_id>
    <secondary_id>NCI-2019-08790</secondary_id>
    <nct_id>NCT04426500</nct_id>
  </id_info>
  <brief_title>Use of Perioperative Pain Blocks In Urological Surgery</brief_title>
  <official_title>Use of Perioperative Pain Blocks In Urological Surgery: A Phase III Randomized Single Blind Single Center Three Arm Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study team aims to prospectively compare Placebo (local administration),&#xD;
      ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided&#xD;
      transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the&#xD;
      prostate and kidney. The study team expects to be able to equally efficiently administer the&#xD;
      blocks using direct visualization and ultrasound guidance. The study team expects that a&#xD;
      negative result would obviate the need for longer operative time by eliminating the need for&#xD;
      the separate ultrasound guided block while a positive result would demonstrate the increased&#xD;
      utility of preoperative ultrasound blocks in managing postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic&#xD;
      blocks) are being employed for the care of urological surgery patients. Local and regional&#xD;
      anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be&#xD;
      challenging, particularly in larger, obese patients. It is unknown how such techniques&#xD;
      compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and&#xD;
      postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall,&#xD;
      potentially allowing for greater ease of access from a laparoscopic approach from within than&#xD;
      the ultrasound guided percutaneous approach.&#xD;
&#xD;
      Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et&#xD;
      al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy&#xD;
      patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was&#xD;
      greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15)&#xD;
      vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014&#xD;
      compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy&#xD;
      patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with&#xD;
      decreased accrual secondary to a surgeon taking a leave of absence during the study period.&#xD;
      Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median&#xD;
      (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2)&#xD;
      vs. 4 (2-6)) on the VAS score, respectively.&#xD;
&#xD;
      A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal&#xD;
      laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were&#xD;
      assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean&#xD;
      (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).&#xD;
&#xD;
      The most recent study, done in 2018, examined 100 randomized patients undergoing&#xD;
      robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while&#xD;
      the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not&#xD;
      otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had&#xD;
      better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).&#xD;
&#xD;
      While all of these studies point to potential efficacy of UTAP, no data has been published to&#xD;
      date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided&#xD;
      administration. While these regional anesthetic blocks carry a theoretical risk of hematoma&#xD;
      or damage to surrounding structures, none of the above studies report any complications with&#xD;
      the injections.&#xD;
&#xD;
      The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP&#xD;
      blocks in patients undergoing robotic surgery of the prostate and kidney. The study team&#xD;
      expects to be able to equally efficiently administer the blocks using direct visualization&#xD;
      and ultrasound guidance. The study team expects that a negative result would obviate the need&#xD;
      for longer operative time by eliminating the need for the separate ultrasound guided block&#xD;
      while a positive result would demonstrate the increased utility of preoperative ultrasound&#xD;
      blocks in managing postoperative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2019</start_date>
  <completion_date type="Actual">February 13, 2021</completion_date>
  <primary_completion_date type="Actual">February 13, 2021</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>
    <intervention_model_description>This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio.&#xD;
People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>A randomization service called Sealedenvelope.com available at https://www.sealedenvelope.com/simple-randomiser/v1/ will be used for allocation concealment to ensure that retrieval of the treatment group assignment is only revealed to appropriate team members on a real time basis after each new patient has been screened and consented. This service allows for allocation concealment that would not be possible if the entire randomization list was made available to team members at the beginning of the study. The security and integrity of the codes used by Sealedenvelope.com follows the Food and Drug Administration (FDA) standards for electronic records and follows the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines.&#xD;
Participants will be blinded to group allocation throughout the study. Due to the nature of the intervention, it is not possible to blind the investigator to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Time and Block Time</measure>
    <time_frame>up to 420 minutes</time_frame>
    <description>Intraoperative time taken to complete surgical blocks and operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Narcotic Use</measure>
    <time_frame>up to 420 minutes</time_frame>
    <description>Intraoperative Narcotic Use in morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Ketoralac Use</measure>
    <time_frame>up to 420 minutes</time_frame>
    <description>Intraoperative Ketoralac Use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Narcotic Use</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>Postoperative Narcotic Use in morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Analgesic Medications</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Amount of Ondansetron Use</measure>
    <time_frame>2 weeks</time_frame>
    <description>Use of antiemetic medications during the postoperative course</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days to Return of Bowel Function</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of days to the return of bowel function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Length of Hospital Stay</measure>
    <time_frame>2 weeks</time_frame>
    <description>Length of hospital stay from time of surgical completion to time of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS in Obese Patients</measure>
    <time_frame>24 hours post operatively</time_frame>
    <description>24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI &gt;30 and BMI&lt;30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Procedure Related Complications</measure>
    <time_frame>2 weeks</time_frame>
    <description>Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Nerve Block</condition>
  <condition>Robotic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Placebo/Local Anesthesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Direct injection of 0.25% bupivacaine into surgical wounds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound-guided transversus abdominus plane (UTAP) block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30mL of 0.25% bupivacaine will be administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic-guided transversus abdominus plane (LTAP) block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30mL of 0.25% bupivacaine will be administered to bilateral TAP using laparoscopic guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacain</intervention_name>
    <description>Direct injection of 0.25% bupivacaine into surgical wounds</description>
    <arm_group_label>Laparoscopic-guided transversus abdominus plane (LTAP) block</arm_group_label>
    <arm_group_label>Placebo/Local Anesthesia</arm_group_label>
    <arm_group_label>Ultrasound-guided transversus abdominus plane (UTAP) block</arm_group_label>
    <other_name>Local anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ultrasound-guided transversus abdominus plane block</intervention_name>
    <description>bilateral TAP using ultrasound guidance in prostatectomies</description>
    <arm_group_label>Ultrasound-guided transversus abdominus plane (UTAP) block</arm_group_label>
    <other_name>UTAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Laparoscopic-guided transversus abdominus plane block</intervention_name>
    <description>bilateral TAP using laparoscopic guidance in prostatectomies</description>
    <arm_group_label>Laparoscopic-guided transversus abdominus plane (LTAP) block</arm_group_label>
    <other_name>LTAP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Undergoing Robotic Assisted Laparoscopic Partial Nephrectomy or Robotic Assisted&#xD;
             Laparoscopic Prostatectomy&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior Partial Nephrectomy or Subtotal Prostatectomy Surgery (organ specific)&#xD;
&#xD;
          -  Conversion to open surgery&#xD;
&#xD;
          -  History of chronic pain&#xD;
&#xD;
          -  History of opiate or alcohol dependence&#xD;
&#xD;
          -  Allergies to local anesthetic&#xD;
&#xD;
          -  Retroperitoneal surgery&#xD;
&#xD;
          -  Single Port Surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reza Mehrazin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.</citation>
    <PMID>22902793</PMID>
  </reference>
  <reference>
    <citation>Aniskevich S, Taner CB, Perry DK, Robards CB, Porter SB, Thomas CS, Logvinov II, Clendenen SR. Ultrasound-guided transversus abdominis plane blocks for patients undergoing laparoscopic hand-assisted nephrectomy: a randomized, placebo-controlled trial. Local Reg Anesth. 2014 May 25;7:11-6. doi: 10.2147/LRA.S61589. eCollection 2014.</citation>
    <PMID>24860252</PMID>
  </reference>
  <reference>
    <citation>Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4.</citation>
    <PMID>27733219</PMID>
  </reference>
  <reference>
    <citation>Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28. Erratum In: J Robot Surg. 2018 Aug 14;:</citation>
    <PMID>30056612</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>April 7, 2022</results_first_submitted>
  <results_first_submitted_qc>April 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2022</results_first_posted>
  <last_update_submitted>April 7, 2022</last_update_submitted>
  <last_update_submitted_qc>April 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Reza Mehrazin</investigator_full_name>
    <investigator_title>Assistant Professor, Urologic Oncology</investigator_title>
  </responsible_party>
  <keyword>Phase III</keyword>
  <keyword>Randomized</keyword>
  <keyword>Single blind</keyword>
  <keyword>Single Center</keyword>
  <keyword>Three arm</keyword>
  <keyword>Non-inferiority</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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>January 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT04426500/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>196 patients were eligible for the study and initially randomized. A total of 143 prostatectomy patients were deemed appropriate candidates for the trial and randomized and 114 participants were enrolled.&#xD;
A total of 53 partial nephrectomy patients were deemed appropriate candidates for the trial. 34 participants were randomized and enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo/Local Anesthesia</title>
          <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
        </group>
        <group group_id="P2">
          <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
          <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
        </group>
        <group group_id="P3">
          <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
          <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
          <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
        </group>
        <group group_id="B2">
          <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
          <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
        </group>
        <group group_id="B3">
          <title>Placebo/Local Anesthesia</title>
          <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
            <count group_id="B2" value="64"/>
            <count group_id="B3" value="28"/>
            <count group_id="B4" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="56"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="9.5"/>
                    <measurement group_id="B2" value="63.0" spread="10.6"/>
                    <measurement group_id="B3" value="63.7" spread="6.6"/>
                    <measurement group_id="B4" value="62.8" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="56"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgical Procedure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Robotic Prostatectomy (RP)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="56"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Robotic Partial Nephrectomy (RPN)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="56"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="56"/>
                    <count group_id="B2" value="64"/>
                    <count group_id="B3" value="28"/>
                    <count group_id="B4" value="148"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.0" spread="4.14"/>
                    <measurement group_id="B2" value="28.6" spread="4.9"/>
                    <measurement group_id="B3" value="26.6" spread="4.25"/>
                    <measurement group_id="B4" value="27.5" spread="4.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS)</title>
        <description>Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain</description>
        <time_frame>24 hours post operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS)</title>
          <description>Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="1.98"/>
                    <measurement group_id="O2" value="3.16" spread="3.10"/>
                    <measurement group_id="O3" value="2.89" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoperative Time and Block Time</title>
        <description>Intraoperative time taken to complete surgical blocks and operative</description>
        <time_frame>up to 420 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Time and Block Time</title>
          <description>Intraoperative time taken to complete surgical blocks and operative</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time Taken to Perform Block</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="6.0" lower_limit="0.5" upper_limit="14.0"/>
                    <measurement group_id="O3" value="2.5" lower_limit="0.5" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total OR Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211.5" lower_limit="137" upper_limit="293"/>
                    <measurement group_id="O2" value="224.5" lower_limit="105" upper_limit="388"/>
                    <measurement group_id="O3" value="221" lower_limit="114" upper_limit="419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoperative Narcotic Use</title>
        <description>Intraoperative Narcotic Use in morphine equivalents</description>
        <time_frame>up to 420 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Narcotic Use</title>
          <description>Intraoperative Narcotic Use in morphine equivalents</description>
          <units>morphine equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="12.6"/>
                    <measurement group_id="O2" value="24.1" spread="12.64"/>
                    <measurement group_id="O3" value="25.5" spread="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoperative Ketoralac Use</title>
        <description>Intraoperative Ketoralac Use</description>
        <time_frame>up to 420 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Ketoralac Use</title>
          <description>Intraoperative Ketoralac Use</description>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O3" value="15" lower_limit="0" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Narcotic Use</title>
        <description>Postoperative Narcotic Use in morphine equivalents</description>
        <time_frame>24 hours post operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Narcotic Use</title>
          <description>Postoperative Narcotic Use in morphine equivalents</description>
          <units>morphine equivalents</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.13" lower_limit="0" upper_limit="60"/>
                    <measurement group_id="O2" value="19.50" lower_limit="0" upper_limit="119"/>
                    <measurement group_id="O3" value="17" lower_limit="0" upper_limit="111.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Analgesic Medications</title>
        <description>The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.</description>
        <time_frame>24 hours post operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Total Analgesic Medications</title>
          <description>The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.</description>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acetaminophen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1650" lower_limit="650" upper_limit="5250"/>
                    <measurement group_id="O2" value="1650" lower_limit="0" upper_limit="101000"/>
                    <measurement group_id="O3" value="1325" lower_limit="0" upper_limit="9450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ketorlac</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="60"/>
                    <measurement group_id="O2" value="30" lower_limit="0" upper_limit="60"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ondansetron</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Amount of Ondansetron Use</title>
        <description>Use of antiemetic medications during the postoperative course</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>The Amount of Ondansetron Use</title>
          <description>Use of antiemetic medications during the postoperative course</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.19"/>
                    <measurement group_id="O2" value="0.31" spread="1.30"/>
                    <measurement group_id="O3" value="0.29" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days to Return of Bowel Function</title>
        <description>Number of days to the return of bowel function</description>
        <time_frame>2 weeks</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days to Return of Bowel Function</title>
          <description>Number of days to the return of bowel function</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Length of Hospital Stay</title>
        <description>Length of hospital stay from time of surgical completion to time of discharge.</description>
        <time_frame>2 weeks</time_frame>
        <population>Data not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>The Length of Hospital Stay</title>
          <description>Length of hospital stay from time of surgical completion to time of discharge.</description>
          <population>Data not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS in Obese Patients</title>
        <description>24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI &gt;30 and BMI&lt;30</description>
        <time_frame>24 hours post operatively</time_frame>
        <population>participants divided by BMI &gt;30 and BMI &lt;30</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>VAS in Obese Patients</title>
          <description>24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI &gt;30 and BMI&lt;30</description>
          <population>participants divided by BMI &gt;30 and BMI &lt;30</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMI &gt;30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="2.21"/>
                    <measurement group_id="O2" value="4.09" spread="2.94"/>
                    <measurement group_id="O3" value="2.33" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMI &lt;30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="40"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.29" spread="1.95"/>
                    <measurement group_id="O2" value="2.67" spread="3.11"/>
                    <measurement group_id="O3" value="3.00" spread="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Procedure Related Complications</title>
        <description>Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo/Local Anesthesia</title>
            <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
          </group>
          <group group_id="O2">
            <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
            <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
          </group>
          <group group_id="O3">
            <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
            <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Procedure Related Complications</title>
          <description>Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="64"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <desc>There were no adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo/Local Anesthesia</title>
          <description>Up to 60ml of 0.25% bupivacaine was injected directly into each of the port sites and specimen extraction site at the conclusion of the procedure prior to skin closure.</description>
        </group>
        <group group_id="E2">
          <title>Ultrasound-guided Transversus Abdominus Plane (UTAP) Block</title>
          <description>30mL of 0.25% bupivacaine administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% aliquot bupivacaine unilateral administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Ultrasound-guided transversus abdominus plane block: bilateral TAP using ultrasound guidance in prostatectomies</description>
        </group>
        <group group_id="E3">
          <title>Robotic -Guided Transversus Abdominus Plane (RTAP) Block</title>
          <description>30mL of 0.25% bupivacaine injected bilaterally in the TAP plane using a RTAP through the assistant port with a laparoscopic needle driver guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).&#xD;
Bupivacain: Direct injection of 0.25% bupivacaine into surgical wounds&#xD;
Laparoscopic-guided transversus abdominus plane block: bilateral TAP using laparoscopic guidance in prostatectomies</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="64"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This trial reflected the practice of a busy academic tertiary care center. There were numerous anesthesiologists performing the UTAP and the choice of intraoperative anesthetic and medications given was uncontrolled. In addition, multiple surgeons accrued patients to the trial with variances in operative technique. This heterogeneity among anesthesiologists and surgeons does introduce confounders but also lends to the generalizability of the present study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Reza Mehrazin</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>(212) 241-4812</phone>
      <email>reza.mehrazin@mountsinai.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04426500
org study id: GCO 19-1532
secondary id: NCI-2019-08790
nct id: NCT04426500
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study team aims to prospectively compare Placebo (local administration),
      ultrasound-guided transversus abdominis plane (UTAP) blocks, and laparoscopic-guided
      transversus abdominis plane (LTAP) blocks in patients undergoing robotic surgery of the
      prostate and kidney. The study team expects to be able to equally efficiently administer the
      blocks using direct visualization and ultrasound guidance. The study team expects that a
      negative result would obviate the need for longer operative time by eliminating the need for
      the separate ultrasound guided block while a positive result would demonstrate the increased
      utility of preoperative ultrasound blocks in managing postoperative pain.
Currently, ultrasound-guided transversus abdominis plane (UTAP) blocks (regional anesthetic
      blocks) are being employed for the care of urological surgery patients. Local and regional
      anesthesia is commonly used throughout surgical fields. However, ultrasound-guidance can be
      challenging, particularly in larger, obese patients. It is unknown how such techniques
      compare to laparoscopic-guided blockade, with respect to time to perform, learning curve, and
      postoperative analgesia. The transversus abdominis plane lies deep within the abdominal wall,
      potentially allowing for greater ease of access from a laparoscopic approach from within than
      the ultrasound guided percutaneous approach.

      Prior randomized studies have been completed comparing UTAP and Placebo. In 2012 Hosgood et
      al. compared UTAP and placebo (UTAP w/ saline) in 46 live-donor laparoscopic nephrectomy
      patients (24 UTAP vs. 22 placebo). Pain control (measured using the 0-10 VAS scale) was
      greater on post-operative day (POD) 1 in patients receiving UTAP than in controls, 19 (15)
      vs. 37 (20) (presented as mean (SD)), respectively. A similar randomized study in 2014
      compared UTAP and placebo (UTAP w/saline) in 21 hand assisted laparoscopic nephrectomy
      patients (10 UTAP vs. 11 placebo). The study was initially powered for 50 patients but with
      decreased accrual secondary to a surgeon taking a leave of absence during the study period.
      Pain scores were recorded using the 0-10 VAS score. Postoperatively at 24 hours (median
      (IQR)) UTAP patients demonstrated decreased postoperative pain than placebo patients (1 (0-2)
      vs. 4 (2-6)) on the VAS score, respectively.

      A larger study, done in 2016, with 80 randomized patients undergoing retroperitoneal
      laparoscopic urologic surgery compared UTAP (40) and saline UTAP (40). Pain scores were
      assessed using the 0-100 VAS score scale. On POD1, UTAP group had lower pain scores (mean
      (SD)) of 8.4 (5.9) vs. placebo 28.3 (12.2).

      The most recent study, done in 2018, examined 100 randomized patients undergoing
      robotic-assisted laparoscopic prostatectomies. Fifty patients were given UTAP blocks while
      the others received no block. A Numerical Rating Scale (assumed to range from 0-10 as not
      otherwise specified) was used to assess pain. Patients receiving the block at 24 hours had
      better pain control (mean (SD)) (1.8 (0.82) vs. 3.57 (0.64)).

      While all of these studies point to potential efficacy of UTAP, no data has been published to
      date comparing laparoscopic administration of the TAP block (LTAP) to ultrasound guided
      administration. While these regional anesthetic blocks carry a theoretical risk of hematoma
      or damage to surrounding structures, none of the above studies report any complications with
      the injections.

      The study team aims to prospectively compare Placebo (local administration), UTAP, and LTAP
      blocks in patients undergoing robotic surgery of the prostate and kidney. The study team
      expects to be able to equally efficiently administer the blocks using direct visualization
      and ultrasound guidance. The study team expects that a negative result would obviate the need
      for longer operative time by eliminating the need for the separate ultrasound guided block
      while a positive result would demonstrate the increased utility of preoperative ultrasound
      blocks in managing postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a single-center, single-blinded, (stratified) randomized placebo-controlled three-arm non-inferiority trial with 2:2:1 allocation ratio.
People who meet eligibility requirements and provide informed consent will be randomly allocated to 3 groups to receive either UTAP, LTAP or Placebo with a 2:2:1 allocation ratio. The allocation sequence will be stratified by type of surgery (prostatectomy or partial nephrectomy) using stratified block randomization with randomly varying block sizes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias. Investigators will be blinded to the size of each block with only the study statistician responsible for generating the randomization list knowing this information.
primary purpose: Supportive Care
masking: Single (Participant)
masking description: A randomization service called Sealedenvelope.com available at https://www.sealedenvelope.com/simple-randomiser/v1/ will be used for allocation concealment to ensure that retrieval of the treatment group assignment is only revealed to appropriate team members on a real time basis after each new patient has been screened and consented. This service allows for allocation concealment that would not be possible if the entire randomization list was made available to team members at the beginning of the study. The security and integrity of the codes used by Sealedenvelope.com follows the Food and Drug Administration (FDA) standards for electronic records and follows the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines.
Participants will be blinded to group allocation throughout the study. Due to the nature of the intervention, it is not possible to blind the investigator to group allocation.
measure: Visual Analog Scale (VAS)
time frame: 24 hours post operatively
description: Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain
measure: Intraoperative Time and Block Time
time frame: up to 420 minutes
description: Intraoperative time taken to complete surgical blocks and operative
measure: Intraoperative Narcotic Use
time frame: up to 420 minutes
description: Intraoperative Narcotic Use in morphine equivalents
measure: Intraoperative Ketoralac Use
time frame: up to 420 minutes
description: Intraoperative Ketoralac Use
measure: Postoperative Narcotic Use
time frame: 24 hours post operatively
description: Postoperative Narcotic Use in morphine equivalents
measure: Total Analgesic Medications
time frame: 24 hours post operatively
description: The 24-hour cumulative postoperative opioid analgesic requirement was calculated using standard tables to morphine equivalents.
measure: The Amount of Ondansetron Use
time frame: 2 weeks
description: Use of antiemetic medications during the postoperative course
measure: Number of Days to Return of Bowel Function
time frame: 2 weeks
description: Number of days to the return of bowel function
measure: The Length of Hospital Stay
time frame: 2 weeks
description: Length of hospital stay from time of surgical completion to time of discharge.
measure: VAS in Obese Patients
time frame: 24 hours post operatively
description: 24 hour postoperative pain scores recorded using the visual analog scale (VAS) in obese patients. Visual analog scale (VAS) is a pain rating scale, with full scale from 0 to 10, higher score indicating more pain. Comparison in patients with BMI >30 and BMI<30
measure: Number of Procedure Related Complications
time frame: 2 weeks
description: Procedure related complications and adverse events including bleeding or injection of anesthetic intravascular was determined according to Common Terminology Criteria for Adverse Events (CTCAE v 4.0).
arm group label: Placebo/Local Anesthesia
arm group type: Placebo Comparator
description: Direct injection of 0.25% bupivacaine into surgical wounds
arm group label: Ultrasound-guided transversus abdominus plane (UTAP) block
arm group type: Active Comparator
description: 30mL of 0.25% bupivacaine will be administered to bilateral TAP using ultrasound guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
arm group label: Laparoscopic-guided transversus abdominus plane (LTAP) block
arm group type: Experimental
description: 30mL of 0.25% bupivacaine will be administered to bilateral TAP using laparoscopic guidance in prostatectomies. 40ml 0.25% bupivacaine unilateral will be administered in nephrectomy patients (weight based dosage permitting).
intervention type: Drug
intervention name: Bupivacain
description: Direct injection of 0.25% bupivacaine into surgical wounds
arm group label: Laparoscopic-guided transversus abdominus plane (LTAP) block
arm group label: Placebo/Local Anesthesia
arm group label: Ultrasound-guided transversus abdominus plane (UTAP) block
other name: Local anesthesia
intervention type: Drug
intervention name: Ultrasound-guided transversus abdominus plane block
description: bilateral TAP using ultrasound guidance in prostatectomies
arm group label: Ultrasound-guided transversus abdominus plane (UTAP) block
other name: UTAP
intervention type: Drug
intervention name: Laparoscopic-guided transversus abdominus plane block
description: bilateral TAP using laparoscopic guidance in prostatectomies
arm group label: Laparoscopic-guided transversus abdominus plane (LTAP) block
other name: LTAP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reza Mehrazin, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
citation: Hosgood SA, Thiyagarajan UM, Nicholson HF, Jeyapalan I, Nicholson ML. Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy. Transplantation. 2012 Sep 15;94(5):520-5. doi: 10.1097/TP.0b013e31825c1697.
PMID: 22902793
citation: Aniskevich S, Taner CB, Perry DK, Robards CB, Porter SB, Thomas CS, Logvinov II, Clendenen SR. Ultrasound-guided transversus abdominis plane blocks for patients undergoing laparoscopic hand-assisted nephrectomy: a randomized, placebo-controlled trial. Local Reg Anesth. 2014 May 25;7:11-6. doi: 10.2147/LRA.S61589. eCollection 2014.
PMID: 24860252
citation: Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4.
PMID: 27733219
citation: Dal Moro F, Aiello L, Pavarin P, Zattoni F. Ultrasound-guided transversus abdominis plane block (US-TAPb) for robot-assisted radical prostatectomy: a novel '4-point' technique-results of a prospective, randomized study. J Robot Surg. 2019 Feb;13(1):147-151. doi: 10.1007/s11701-018-0858-6. Epub 2018 Jul 28. Erratum In: J Robot Surg. 2018 Aug 14;:
PMID: 30056612
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Reza Mehrazin
investigator title: Assistant Professor, Urologic Oncology
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This trial reflected the practice of a busy academic tertiary care center. There were numerous anesthesiologists performing the UTAP and the choice of intraoperative anesthetic and medications given was uncontrolled. In addition, multiple surgeons accrued patients to the trial with variances in operative technique. This heterogeneity among anesthesiologists and surgeons does introduce confounders but also lends to the generalizability of the present study.
point of contact: 