<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/NCT03249168</url>
  </required_header>
  <id_info>
    <org_study_id>MFGA</org_study_id>
    <nct_id>NCT03249168</nct_id>
  </id_info>
  <brief_title>Duloxetine for Post Laparoscopic Shoulder Pain</brief_title>
  <official_title>Preoperative Duloxetine to Prevent Postoperative Shoulder Pain After Gynecological Laparoscopies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite recent advances in minimal invasive surgery, postoperative pain control remains a&#xD;
      challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious&#xD;
      favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is&#xD;
      minimally invasive, has less pain, and needs less postoperative analgesic use compared with&#xD;
      open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients may feel much more discomfort from their shoulder pain than incision pain .&#xD;
      Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and&#xD;
      phrenic nerve by local acidosis and irritative effect of carbon dioxide during&#xD;
      pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin&#xD;
      and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive&#xD;
      disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also&#xD;
      used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint&#xD;
      pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat&#xD;
      diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both&#xD;
      are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after&#xD;
      laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and&#xD;
      since duloxetine is an antineuropathic pain medications we assume its use will ameliorate&#xD;
      diaphragmatic irritation and hencepost laparoscopic shoulder pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>post laparoscopic shoulder pain</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sedation</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Ramsey Sedation Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Post Laparoscopic Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>case group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Duloxetine 60mg orally 12 hours before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo (glucose powder in a tablet) orally 12 hours before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine 60mg</intervention_name>
    <description>tablet</description>
    <arm_group_label>case group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal females&#xD;
&#xD;
          -  Patient consent&#xD;
&#xD;
          -  Patients with ASA class I-II&#xD;
&#xD;
          -  Elective gynecological laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index ≥ 40&#xD;
&#xD;
          -  Consuming any pain killers routinely within 48 hours before the surgery&#xD;
&#xD;
          -  Smoking, drug abuse&#xD;
&#xD;
          -  Patients with major psychiatric disorders, epilepsy or history of convulsion&#xD;
&#xD;
          -  Any known kidney or hepatic disorders&#xD;
&#xD;
          -  History of any other pervious laparotomy, laparoscopy, or other pelvic manipulation or&#xD;
             pathology except normal vaginal delivery&#xD;
&#xD;
          -  History of chest or mediastinal surgery or pathology&#xD;
&#xD;
          -  Recent flu (six weeks before surgery)&#xD;
&#xD;
          -  Suspected to malignancy as pathology&#xD;
&#xD;
          -  Those who complained from shoulder pain just before surgery in the first Visual Analog&#xD;
             Scale assessment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine, Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.</citation>
    <PMID>26705527</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>mina fayez ghalyoom</investigator_full_name>
    <investigator_title>principal invstigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
  </intervention_browse>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.ncbi.nlm.nih.gov/pubmed/26705527</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/NCT03249168
org study id: MFGA
nct id: NCT03249168
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Despite recent advances in minimal invasive surgery, postoperative pain control remains a
      challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious
      favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is
      minimally invasive, has less pain, and needs less postoperative analgesic use compared with
      open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure
Many patients may feel much more discomfort from their shoulder pain than incision pain .
      Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and
      phrenic nerve by local acidosis and irritative effect of carbon dioxide during
      pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin
      and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive
      disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also
      used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint
      pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat
      diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both
      are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after
      laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and
      since duloxetine is an antineuropathic pain medications we assume its use will ameliorate
      diaphragmatic irritation and hencepost laparoscopic shoulder pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: double-blind
measure: post laparoscopic shoulder pain
time frame: 12 hours after surgery
description: The presence and severity of Post laparoscopic shoulder pain will be recorded using a Visual Analog Scale
measure: sedation
time frame: 12 hours after surgery
description: Ramsey Sedation Scale
arm group label: case group
arm group type: Experimental
description: Duloxetine 60mg orally 12 hours before surgery
arm group label: Control group
arm group type: Active Comparator
description: Placebo (glucose powder in a tablet) orally 12 hours before surgery
intervention type: Drug
intervention name: Duloxetine 60mg
description: tablet
arm group label: case group
intervention type: Drug
intervention name: Placebo
description: Tablet
arm group label: Control group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Valadan M, Banifatemi S, Yousefshahi F. Preoperative Gabapentin to Prevent Postoperative Shoulder Pain After Laparoscopic Ovarian Cystectomy: A Randomized Clinical Trial. Anesth Pain Med. 2015 Dec 5;5(6):e31524. doi: 10.5812/aapm.31524. eCollection 2015 Dec.
PMID: 26705527
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: mina fayez ghalyoom
investigator title: principal invstigator
mesh term: Shoulder Pain
mesh term: Duloxetine Hydrochloride
study doc: 