<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/NCT04440475</url>
  </required_header>
  <id_info>
    <org_study_id>20-068</org_study_id>
    <nct_id>NCT04440475</nct_id>
  </id_info>
  <brief_title>Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy</brief_title>
  <acronym>SACROTAP</acronym>
  <official_title>Tap Block vs Conventional Pain Medication for Patients Undergoing Robotic Sacrocolpopexy, a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ProMedica Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ProMedica Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess whether the transversus abdominis plane block (Tap&#xD;
      block) is different than the oral postoperative pain medications in controlling pain after&#xD;
      robotic sacrocolpopexy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sacrocolpopexy is a procedure to correct prolapse of the vaginal apex (top of the vagina) in&#xD;
      women who have had a previous hysterectomy. The operation is designed to restore the vagina&#xD;
      to its normal position and function. Pain management is an important aspect of perioperative&#xD;
      anesthetic care. Acute postoperative pain control impacting surgical outcomes remains a&#xD;
      controversial topic&#xD;
&#xD;
      The transversus abdominis plane (TAP) block was first presented by Rafi in 2001 as a&#xD;
      landmark-guided technique via the triangle of Petit to achieve a field block. It involves the&#xD;
      injection of a local anesthetic between the internal oblique muscle and transversus abdominis&#xD;
      muscle. The thoracolumbar nerves originating from the T6 to L1 spinal roots run into this&#xD;
      plane and supply sensory nerves to the anterolateral abdominal wall, the local anesthetic in&#xD;
      this plane can block the neural afferents and provide analgesia to the anterolateral&#xD;
      abdominal wall. The Tap block is a widely used procedure to help in postoperative pain&#xD;
      management, it is easily performed, cost-effective, with minimal procedure-related morbidity.&#xD;
      The use of Tap block is in concordance with several of the goals of Enhanced Recovery After&#xD;
      Surgery Pathways (ERAS). In a systematic review comparing Tap bloc to no tap block for&#xD;
      post-hysterectomy pain found that visual analog score (VAS) was lower in patients receiving&#xD;
      tap block in both open and laparoscopic hysterectomy procedures. The study found no&#xD;
      significant difference in the amount of morphine used by patients who underwent laparoscopic&#xD;
      hysterectomy and received a tap block. Currently the standard of care at Promedica hospitals&#xD;
      is to give patients oral medications to control postop pain after sacrocolpopexy. Patients&#xD;
      are offered to receive a tap block or no, and it is up to the patient to receive the tap&#xD;
      block or no.&#xD;
&#xD;
      No Studies on Tap block after Sacrocolpopexy have been published yet. Our hypothesis is that&#xD;
      Tap block will reduce the need for pain meds during the first 24 to 48 hours after&#xD;
      sacrocolpopexy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>N/A</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>The investigators will perform a pilot randomized control trial, where one group will be receiving TAP blocks whereas the other group will be receiving regular postoperative pain medications (acetaminophen, ibuprofen, tramadol orally upon discharge). Randomization will be completed using a computer-generated randomization sequence using 1:1 ratio with blocking in groups of 4. The randomization sequence will kept in our research office and investigators enrolling subjects will not have access. Sequentially numbered sealed opaque envelopes will be prepared following the randomization sequence, randomized participants will receive an envelope in sequential order.&#xD;
The patient and the person performing the statistical analyses will be blinded.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The patient and the person performing the analysis will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>amount of postoperative oral pain medication</measure>
    <time_frame>48 hours</time_frame>
    <description>amount of postoperative oral pain medication used by patient after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric Rating Scale (NRS) scale improvement</measure>
    <time_frame>48 hours</time_frame>
    <description>Numeric rating scale for pain will be assessed (0-10: 0 being no pain, 10 being the worst pain possible)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Prolapse</condition>
  <condition>Prolapse; Female</condition>
  <condition>Prolapse, Vaginal</condition>
  <condition>Prolapse; Vagina, Posthysterectomy</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Tap Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAP block at the end of the surgery, in addition to conventional postoperative oral medication as needed&#xD;
postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional postoperative oral medication</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <description>Tap block description:&#xD;
The skin is prepped and draped in a sterile fashion for a lateral to posterior/lateral approach to the Transverse Abdominis Plane (TAP). The Anesthesiologists use ultrasound guidance for all TAP blocks and pre mix 60cc of 0.2% ropivicaine with 10mg of preservative free dexamethasone. After the plane is identified in approximately the mid axillary line, a 17g Tuohy needle is used under ultrasound guidance to enter the potential space from an anterior approach. The needle is visualized in-plane with the ultrasound probe, traversing the exterior and interior oblique muscles and penetrating through the posterior fascia of internal oblique into the transverse abdominal plane. Once the Tuohy is in place, the needle is aspirated and the plane is hydro-dissected using 0.2% Ropivicaine with 10mg of dexamethasone. The anesthesiologist will use 30ml of 0.2% Ropivicaine on each side.</description>
    <arm_group_label>Tap Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age or older&#xD;
&#xD;
          -  Planning for surgical treatment of Pelvic Organ Prolapse (POP) with robotic&#xD;
             sacrocolpopexy and rectocele repair under general anesthesia&#xD;
&#xD;
          -  Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing&#xD;
&#xD;
          -  Allergy to ropivicaine&#xD;
&#xD;
          -  History of drug/alcohol abuse&#xD;
&#xD;
          -  Severe cardiovascular, hepatic, renal disease, or neurological impairment Long-acting&#xD;
             opioid use within 3 days or any opioid use within 24 hours before surgery&#xD;
&#xD;
          -  Contraindication to: acetaminophen, tramadol, non-steroidal anti- inflammatory drugs&#xD;
             (NSAID)&#xD;
&#xD;
          -  Administration of an investigational drug within 30 days before study&#xD;
&#xD;
          -  Chronic pain syndromes&#xD;
&#xD;
          -  Daily NSAID/opioid use&#xD;
&#xD;
          -  Patients not undergoing general anesthesia&#xD;
&#xD;
          -  Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or&#xD;
             fistula repair&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dani Zoorob, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ProMedica Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dani Zoorob, MD</last_name>
    <phone>4192913125</phone>
    <email>dani.zoorobmd@promedica.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ibrahim Tsolakian, MD</last_name>
    <phone>2485679262</phone>
    <email>ibrahim.tsolakian@utoledo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Promedica Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dani Zoorob, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Ibrahim Tsolakain, MD</last_name>
      <phone>2485679262</phone>
      <email>ibrahim.tsolakian@utoledo.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.</citation>
    <PMID>25580086</PMID>
  </reference>
  <reference>
    <citation>Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.</citation>
    <PMID>11576144</PMID>
  </reference>
  <reference>
    <citation>Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.</citation>
    <PMID>18428988</PMID>
  </reference>
  <reference>
    <citation>Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25.</citation>
    <PMID>28742435</PMID>
  </reference>
  <reference>
    <citation>Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.</citation>
    <PMID>29723644</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Prolapse</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data (IPD) will not be shared with other researchers, data will be destroyed 3 years after study completion</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04440475
org study id: 20-068
nct id: NCT04440475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to assess whether the transversus abdominis plane block (Tap
      block) is different than the oral postoperative pain medications in controlling pain after
      robotic sacrocolpopexy.
Sacrocolpopexy is a procedure to correct prolapse of the vaginal apex (top of the vagina) in
      women who have had a previous hysterectomy. The operation is designed to restore the vagina
      to its normal position and function. Pain management is an important aspect of perioperative
      anesthetic care. Acute postoperative pain control impacting surgical outcomes remains a
      controversial topic

      The transversus abdominis plane (TAP) block was first presented by Rafi in 2001 as a
      landmark-guided technique via the triangle of Petit to achieve a field block. It involves the
      injection of a local anesthetic between the internal oblique muscle and transversus abdominis
      muscle. The thoracolumbar nerves originating from the T6 to L1 spinal roots run into this
      plane and supply sensory nerves to the anterolateral abdominal wall, the local anesthetic in
      this plane can block the neural afferents and provide analgesia to the anterolateral
      abdominal wall. The Tap block is a widely used procedure to help in postoperative pain
      management, it is easily performed, cost-effective, with minimal procedure-related morbidity.
      The use of Tap block is in concordance with several of the goals of Enhanced Recovery After
      Surgery Pathways (ERAS). In a systematic review comparing Tap bloc to no tap block for
      post-hysterectomy pain found that visual analog score (VAS) was lower in patients receiving
      tap block in both open and laparoscopic hysterectomy procedures. The study found no
      significant difference in the amount of morphine used by patients who underwent laparoscopic
      hysterectomy and received a tap block. Currently the standard of care at Promedica hospitals
      is to give patients oral medications to control postop pain after sacrocolpopexy. Patients
      are offered to receive a tap block or no, and it is up to the patient to receive the tap
      block or no.

      No Studies on Tap block after Sacrocolpopexy have been published yet. Our hypothesis is that
      Tap block will reduce the need for pain meds during the first 24 to 48 hours after
      sacrocolpopexy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will perform a pilot randomized control trial, where one group will be receiving TAP blocks whereas the other group will be receiving regular postoperative pain medications (acetaminophen, ibuprofen, tramadol orally upon discharge). Randomization will be completed using a computer-generated randomization sequence using 1:1 ratio with blocking in groups of 4. The randomization sequence will kept in our research office and investigators enrolling subjects will not have access. Sequentially numbered sealed opaque envelopes will be prepared following the randomization sequence, randomized participants will receive an envelope in sequential order.
The patient and the person performing the statistical analyses will be blinded.
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: The patient and the person performing the analysis will be masked
measure: amount of postoperative oral pain medication
time frame: 48 hours
description: amount of postoperative oral pain medication used by patient after surgery
measure: Numeric Rating Scale (NRS) scale improvement
time frame: 48 hours
description: Numeric rating scale for pain will be assessed (0-10: 0 being no pain, 10 being the worst pain possible)
arm group label: Tap Block
arm group type: Experimental
description: TAP block at the end of the surgery, in addition to conventional postoperative oral medication as needed
postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours
arm group label: Conventional postoperative oral medication
arm group type: No Intervention
description: postoperative conventional oral medication as needed: Acetaminophen 650 mg Q 6 hours Ibuprofen 600 mg Q 6 hours Tramadol 50 mg Q 6 hours
intervention type: Procedure
intervention name: TAP block
description: Tap block description:
The skin is prepped and draped in a sterile fashion for a lateral to posterior/lateral approach to the Transverse Abdominis Plane (TAP). The Anesthesiologists use ultrasound guidance for all TAP blocks and pre mix 60cc of 0.2% ropivicaine with 10mg of preservative free dexamethasone. After the plane is identified in approximately the mid axillary line, a 17g Tuohy needle is used under ultrasound guidance to enter the potential space from an anterior approach. The needle is visualized in-plane with the ultrasound probe, traversing the exterior and interior oblique muscles and penetrating through the posterior fascia of internal oblique into the transverse abdominal plane. Once the Tuohy is in place, the needle is aspirated and the plane is hydro-dissected using 0.2% Ropivicaine with 10mg of dexamethasone. The anesthesiologist will use 30ml of 0.2% Ropivicaine on each side.
arm group label: Tap Block
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dani Zoorob, MD
role: Principal Investigator
affiliation: ProMedica Health System
last name: Dani Zoorob, MD
phone: 4192913125
email: dani.zoorobmd@promedica.org
last name: Ibrahim Tsolakian, MD
phone: 2485679262
email: ibrahim.tsolakian@utoledo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.
PMID: 25580086
citation: Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.
PMID: 11576144
citation: Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
PMID: 18428988
citation: Kim AJ, Yong RJ, Urman RD. The Role of Transversus Abdominis Plane Blocks in Enhanced Recovery After Surgery Pathways for Open and Laparoscopic Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):909-914. doi: 10.1089/lap.2017.0337. Epub 2017 Jul 25.
PMID: 28742435
citation: Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.
PMID: 29723644
responsible party type: Sponsor
mesh term: Uterine Prolapse
mesh term: Prolapse
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: Individual participant data (IPD) will not be shared with other researchers, data will be destroyed 3 years after study completion