<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/NCT03266926</url>
  </required_header>
  <id_info>
    <org_study_id>SBK Vaginal Pack Study</org_study_id>
    <nct_id>NCT03266926</nct_id>
  </id_info>
  <brief_title>Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?</brief_title>
  <official_title>Does the Use of Bupivacaine Soaked Vaginal Packing Following Vaginal Surgery Decrease Postoperative Pain?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In current practice, packing in the vagina overnight after vaginal surgery is typically used&#xD;
      to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either&#xD;
      estrogen cream or bupivacaine at the investigators' hospital . There are reports in the&#xD;
      literature that show nasal packing soaked with local anesthetic after nasal sinus surgery&#xD;
      reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked&#xD;
      vaginal packing after vaginal surgery and if this is associated with a reduction in&#xD;
      post-surgical pain scores.&#xD;
&#xD;
      The investigators seek to investigate if vaginal packing soaked with a local anesthetic&#xD;
      reduces post-operative pain while providing the necessary action of minimizing potential&#xD;
      post-surgical bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort, single centre, single-blinded study looking at a population of&#xD;
      women post vaginal surgery with vaginal packing that is either coated with estrogen cream or&#xD;
      0.25% Bupivacaine + epinephrine (local anesthetic). Patients who have booked vaginal surgery&#xD;
      for prolapse repair will be invited to participate in this study. A document describing the&#xD;
      study will be provided for reading and will include the consent for the study. At the end of&#xD;
      surgery, a vaginal pack is placed to decrease potential bleeding post surgery. At this time,&#xD;
      patients will receive either vaginal packing with estrogen, or, the vaginal packing with&#xD;
      0.25% bupivacaine + epinephrine, according to physician preference. Patients and the nurses&#xD;
      caring for them post surgery will be blinded as to which group the patient has been assigned&#xD;
      to. The nurses in the recovery room and post operative ward will ask patients post surgery&#xD;
      the day of surgery, (POD#0, two and six hours post OR) and POD#1 to rate the patients'&#xD;
      surgical pain with a standardized, validated VAS pain score. Secondary outcomes will be&#xD;
      recorded: the amount of analgesics used in hospital after surgery, intra-operative blood&#xD;
      loss, post operative hemoglobin, the number of days until the patient is able to void, the&#xD;
      amount of analgesics used at home after surgery (patients will be asked to keep a record of&#xD;
      the total number of oral analgesic pain tablets used and on which day post surgery they&#xD;
      stopped using pain medications) and other post surgical complications. Data will be stored in&#xD;
      a secure, password protected desktop on site. Each patient will be assigned a unique number&#xD;
      which can be traced back to a master file which will include patient identifiers (name, MRN,&#xD;
      DOB). Data will be analyzed with the appropriate statistical tests. There are no additional&#xD;
      tests or visits for patients. Patient study assignment will be disclosed to them at the 6&#xD;
      week routine post surgical examination/assessment visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Weeks</target_duration>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>The outcome measure will be assessed six hours postoperative</time_frame>
    <description>Primary outcome is postoperative pain score 6 hours post surgery on POD#0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Blood Loss</measure>
    <time_frame>One time measurement, intra-operative</time_frame>
    <description>Estimate by the surgeon regarding total blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Hemoglobin</measure>
    <time_frame>Morning of postoperative day one</time_frame>
    <description>Measure of hemoglobin on the morning of postoperative day one</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Use In Hospital</measure>
    <time_frame>From when surgery ends to time of discharge from hospital post operative day 1</time_frame>
    <description>Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative per vaginal blood loss</measure>
    <time_frame>From when surgery ends to time of discharge from hospital post operative day 1</time_frame>
    <description>As subjectively described by RN in chart</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trial of Void</measure>
    <time_frame>Up to six weeks postoperative</time_frame>
    <description>Number of days required by the patient to pass a trial of void</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Use Postoperative</measure>
    <time_frame>Up to six weeks postoperative</time_frame>
    <description>Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use from date of discharge to six week follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>The outcome measure will be assessed two hours postoperative</time_frame>
    <description>postoperative pain score 2 hours post surgery on POD#0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (VAS)</measure>
    <time_frame>The outcome measure will be assessed on the morning of postoperative day one.</time_frame>
    <description>postoperative pain score on the morning of postoperative day one</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Postoperative Patients with premarin</arm_group_label>
    <description>Patients who undergo vaginal surgery at Sunnybrook Health Sciences Centre (SHSC) who require vaginal packing postoperatively and receive premarin vaginal cream coated packing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postoperative Patients with bupivacaine</arm_group_label>
    <description>Patients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.</description>
    <arm_group_label>Postoperative Patients with bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Premarin Vaginal cream</intervention_name>
    <description>A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.</description>
    <arm_group_label>Postoperative Patients with premarin</arm_group_label>
    <other_name>estrogen vaginal cream</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing vaginal reconstructive surgery at Sunnybrook Health Sciences Centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of 4 attending physicians (urogynecologists) of Sunnybrook Health Sciences&#xD;
             Centre planning to undergo a vaginal hysterectomy and/or vaginal reconstructive&#xD;
             surgery for pelvic organ prolapse.&#xD;
&#xD;
          -  Subjects aged 18 years and older and able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing abdominal prolapse repair or no vaginal repairs&#xD;
&#xD;
          -  Patients undergoing vaginal obliterative procedures&#xD;
&#xD;
          -  Patients with a known allergy or adverse reaction to Bupivacaine or contraindication&#xD;
             to Premarin&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants are eligible if they are undergoing vaginal reconstructive surgery.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre, University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Abdullah B, Khong SY, Tan PC. Oestrogen-soaked vaginal packing for decubitus ulcer in advanced pelvic organ prolapse: a case series. Int Urogynecol J. 2016 Jul;27(7):1057-62. doi: 10.1007/s00192-015-2930-3. Epub 2015 Dec 30.</citation>
    <PMID>26718780</PMID>
  </reference>
  <reference>
    <citation>Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.</citation>
    <PMID>24310987</PMID>
  </reference>
  <reference>
    <citation>Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.</citation>
    <PMID>26825408</PMID>
  </reference>
  <reference>
    <citation>Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.</citation>
    <PMID>22914480</PMID>
  </reference>
  <reference>
    <citation>Simavli S, Kaygusuz I, Kinay T, Akinci Baylan A, Kafali H. Bupivacaine-soaked absorbable gelatin sponges in caesarean section wounds: effect on postoperative pain, analgesic requirement and haemodynamic profile. Int J Obstet Anesth. 2014 Nov;23(4):302-8. doi: 10.1016/j.ijoa.2014.07.004. Epub 2014 Jul 18.</citation>
    <PMID>25281438</PMID>
  </reference>
  <reference>
    <citation>Haytoglu S, Kuran G, Muluk NB, Arikan OK. Different anesthetic agents-soaked sinus packings on pain management after functional endoscopic sinus surgery: which is the most effective? Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1769-77. doi: 10.1007/s00405-015-3807-2. Epub 2015 Oct 28.</citation>
    <PMID>26511988</PMID>
  </reference>
  <reference>
    <citation>Buchanan MA, Dunn GR, Macdougall GM. A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted. J Laryngol Otol. 2005 Apr;119(4):284-8. doi: 10.1258/0022215054020322.</citation>
    <PMID>15949082</PMID>
  </reference>
  <reference>
    <citation>Karaman E, Gungor G, Alimoglu Y, Kilic E, Tarakci E, Bozkurt P, Enver O. The effect of lidocaine, bupivacaine and ropivacaine in nasal packs on pain and hemorrhage after septoplasty. Eur Arch Otorhinolaryngol. 2011 May;268(5):685-9. doi: 10.1007/s00405-010-1432-7. Epub 2010 Dec 1.</citation>
    <PMID>21120661</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</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>Pain, Postoperative</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Estrogens</mesh_term>
    <mesh_term>Estrogens, Conjugated (USP)</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.scribd.com/document/344597619/Study-Protocol</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.scribd.com/document/344597523/Consent-Form</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.scribd.com/document/344597573/Data-Collection-Spreadsheet</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Participant Documents</doc_type>
      <doc_url>https://www.scribd.com/document/344597424/Participant-Documents</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03266926
org study id: SBK Vaginal Pack Study
nct id: NCT03266926
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In current practice, packing in the vagina overnight after vaginal surgery is typically used
      to prevent post-surgical vaginal bleeding. The vaginal packing is usually coated with either
      estrogen cream or bupivacaine at the investigators' hospital . There are reports in the
      literature that show nasal packing soaked with local anesthetic after nasal sinus surgery
      reduces post-surgical pain. To date, no studies have evaluated local anesthetic soaked
      vaginal packing after vaginal surgery and if this is associated with a reduction in
      post-surgical pain scores.

      The investigators seek to investigate if vaginal packing soaked with a local anesthetic
      reduces post-operative pain while providing the necessary action of minimizing potential
      post-surgical bleeding.
This is a prospective cohort, single centre, single-blinded study looking at a population of
      women post vaginal surgery with vaginal packing that is either coated with estrogen cream or
      0.25% Bupivacaine + epinephrine (local anesthetic). Patients who have booked vaginal surgery
      for prolapse repair will be invited to participate in this study. A document describing the
      study will be provided for reading and will include the consent for the study. At the end of
      surgery, a vaginal pack is placed to decrease potential bleeding post surgery. At this time,
      patients will receive either vaginal packing with estrogen, or, the vaginal packing with
      0.25% bupivacaine + epinephrine, according to physician preference. Patients and the nurses
      caring for them post surgery will be blinded as to which group the patient has been assigned
      to. The nurses in the recovery room and post operative ward will ask patients post surgery
      the day of surgery, (POD#0, two and six hours post OR) and POD#1 to rate the patients'
      surgical pain with a standardized, validated VAS pain score. Secondary outcomes will be
      recorded: the amount of analgesics used in hospital after surgery, intra-operative blood
      loss, post operative hemoglobin, the number of days until the patient is able to void, the
      amount of analgesics used at home after surgery (patients will be asked to keep a record of
      the total number of oral analgesic pain tablets used and on which day post surgery they
      stopped using pain medications) and other post surgical complications. Data will be stored in
      a secure, password protected desktop on site. Each patient will be assigned a unique number
      which can be traced back to a master file which will include patient identifiers (name, MRN,
      DOB). Data will be analyzed with the appropriate statistical tests. There are no additional
      tests or visits for patients. Patient study assignment will be disclosed to them at the 6
      week routine post surgical examination/assessment visit.
observational model: Cohort
time perspective: Prospective
measure: Visual Analog Scale (VAS)
time frame: The outcome measure will be assessed six hours postoperative
description: Primary outcome is postoperative pain score 6 hours post surgery on POD#0
measure: Intraoperative Blood Loss
time frame: One time measurement, intra-operative
description: Estimate by the surgeon regarding total blood loss
measure: Postoperative Hemoglobin
time frame: Morning of postoperative day one
description: Measure of hemoglobin on the morning of postoperative day one
measure: Analgesic Use In Hospital
time frame: From when surgery ends to time of discharge from hospital post operative day 1
description: Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use postoperatively
measure: Post-operative per vaginal blood loss
time frame: From when surgery ends to time of discharge from hospital post operative day 1
description: As subjectively described by RN in chart
measure: Trial of Void
time frame: Up to six weeks postoperative
description: Number of days required by the patient to pass a trial of void
measure: Analgesic Use Postoperative
time frame: Up to six weeks postoperative
description: Compilation of total dose of Tylenol, anti-inflammatory, and narcotic use from date of discharge to six week follow up
measure: Visual Analog Scale (VAS)
time frame: The outcome measure will be assessed two hours postoperative
description: postoperative pain score 2 hours post surgery on POD#0
measure: Visual Analog Scale (VAS)
time frame: The outcome measure will be assessed on the morning of postoperative day one.
description: postoperative pain score on the morning of postoperative day one
arm group label: Postoperative Patients with premarin
description: Patients who undergo vaginal surgery at Sunnybrook Health Sciences Centre (SHSC) who require vaginal packing postoperatively and receive premarin vaginal cream coated packing.
arm group label: Postoperative Patients with bupivacaine
description: Patients who undergo vaginal surgery at Patients who undergo vaginal surgery (SHSC) who require vaginal packing postoperatively and receive bupivacaine soaked packing.
intervention type: Drug
intervention name: Bupivacaine
description: 0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
arm group label: Postoperative Patients with bupivacaine
other name: Marcaine
intervention type: Drug
intervention name: Premarin Vaginal cream
description: A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
arm group label: Postoperative Patients with premarin
other name: estrogen vaginal cream
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Participants are eligible if they are undergoing vaginal reconstructive surgery.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patricia Lee, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
facility: 
country: Canada
citation: Abdullah B, Khong SY, Tan PC. Oestrogen-soaked vaginal packing for decubitus ulcer in advanced pelvic organ prolapse: a case series. Int Urogynecol J. 2016 Jul;27(7):1057-62. doi: 10.1007/s00192-015-2930-3. Epub 2015 Dec 30.
PMID: 26718780
citation: Thiagamoorthy G, Khalil A, Cardozo L, Srikrishna S, Leslie G, Robinson D. The value of vaginal packing in pelvic floor surgery: a randomised double-blind study. Int Urogynecol J. 2014 May;25(5):585-91. doi: 10.1007/s00192-013-2264-y. Epub 2013 Dec 6.
PMID: 24310987
citation: Westermann LB, Crisp CC, Oakley SH, Mazloomdoost D, Kleeman SD, Benbouajili JM, Ghodsi V, Pauls RN. To Pack or Not to Pack? A Randomized Trial of Vaginal Packing After Vaginal Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):111-7. doi: 10.1097/SPV.0000000000000238.
PMID: 26825408
citation: Mercier RJ, Zerden ML. Intrauterine anesthesia for gynecologic procedures: a systematic review. Obstet Gynecol. 2012 Sep;120(3):669-77. doi: 10.1097/AOG.0b013e3182639ab5.
PMID: 22914480
citation: Simavli S, Kaygusuz I, Kinay T, Akinci Baylan A, Kafali H. Bupivacaine-soaked absorbable gelatin sponges in caesarean section wounds: effect on postoperative pain, analgesic requirement and haemodynamic profile. Int J Obstet Anesth. 2014 Nov;23(4):302-8. doi: 10.1016/j.ijoa.2014.07.004. Epub 2014 Jul 18.
PMID: 25281438
citation: Haytoglu S, Kuran G, Muluk NB, Arikan OK. Different anesthetic agents-soaked sinus packings on pain management after functional endoscopic sinus surgery: which is the most effective? Eur Arch Otorhinolaryngol. 2016 Jul;273(7):1769-77. doi: 10.1007/s00405-015-3807-2. Epub 2015 Oct 28.
PMID: 26511988
citation: Buchanan MA, Dunn GR, Macdougall GM. A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted. J Laryngol Otol. 2005 Apr;119(4):284-8. doi: 10.1258/0022215054020322.
PMID: 15949082
citation: Karaman E, Gungor G, Alimoglu Y, Kilic E, Tarakci E, Bozkurt P, Enver O. The effect of lidocaine, bupivacaine and ropivacaine in nasal packs on pain and hemorrhage after septoplasty. Eur Arch Otorhinolaryngol. 2011 May;268(5):685-9. doi: 10.1007/s00405-010-1432-7. Epub 2010 Dec 1.
PMID: 21120661
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Bupivacaine
mesh term: Estrogens
mesh term: Estrogens, Conjugated (USP)
sharing ipd: No
study doc: 
study doc: 
study doc: 
study doc: 