<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/NCT01689597</url>
  </required_header>
  <id_info>
    <org_study_id>18501</org_study_id>
    <nct_id>NCT01689597</nct_id>
  </id_info>
  <brief_title>Epidural Morphine for Analgesia After Traumatic Vaginal Delivery</brief_title>
  <official_title>Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
      This pilot study intends to establish the efficacy of 2 different doses of epidural morphine&#xD;
      for pain management after perineal trauma when using multimodal analgesia as well as the&#xD;
      feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal&#xD;
      delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural&#xD;
      morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid&#xD;
      consumption for breakthrough pain in the first 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn - no participants enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total breakthrough opioid consumption</measure>
    <time_frame>First 24 hours after delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores at rest</measure>
    <time_frame>At 6, 12, 24, and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores with movement</measure>
    <time_frame>At 6, 12, 24, and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of nausea/vomiting</measure>
    <time_frame>At 6, 12, 24, and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of pruritis</measure>
    <time_frame>At 6, 12, 24, and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of sedation</measure>
    <time_frame>At 6, 12, 24, and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first request for additional analgesia</measure>
    <time_frame>First 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with pain control</measure>
    <time_frame>At 24 and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Recovery</measure>
    <time_frame>At 24 and 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetic consumption</measure>
    <time_frame>First 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antipruritic medication consumption</measure>
    <time_frame>First 36 h after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total opioid consumption</measure>
    <time_frame>First 36 h after delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Traumatic Vaginal Delivery</condition>
  <arm_group>
    <arm_group_label>Low dose epidural morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One dose of 1.25 mg epidural morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose epidural morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One dose of 2.5 mg epidural morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One dose of 10 ml saline administered through an epidural catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Comparison of different dosages of drug</description>
    <arm_group_label>High dose epidural morphine</arm_group_label>
    <arm_group_label>Low dose epidural morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is 18 years or older&#xD;
&#xD;
          -  The patient is ASA 1-3&#xD;
&#xD;
          -  Gestation 37-42 weeks&#xD;
&#xD;
          -  The patient had a vaginal delivery&#xD;
&#xD;
          -  The patient received epidural analgesia for labor and delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has refused to participate&#xD;
&#xD;
          -  The patient cannot give informed consent&#xD;
&#xD;
          -  The investigator has significant concerns for maternal or neonatal welfare&#xD;
&#xD;
          -  The patient has a history of allergy to opioids&#xD;
&#xD;
          -  The patient has a history of chronic opioid consumption&#xD;
&#xD;
          -  The patient has a history of narcotic abuse&#xD;
&#xD;
          -  The patient has an allergy to local anesthetics&#xD;
&#xD;
          -  The patient has a contraindication to taking NSAIDs or acetaminophen&#xD;
&#xD;
          -  The patient received combined spinal-epidural analgesia&#xD;
&#xD;
          -  The patient has a history of chronic pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sudha I Singh, MD FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Western Ontario</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01689597
org study id: 18501
nct id: NCT01689597
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This pilot study intends to establish the efficacy of 2 different doses of epidural morphine
      for pain management after perineal trauma when using multimodal analgesia as well as the
      feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal
      delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural
      morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid
      consumption for breakthrough pain in the first 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Total breakthrough opioid consumption
time frame: First 24 hours after delivery
measure: Pain scores at rest
time frame: At 6, 12, 24, and 36 h after delivery
measure: Pain scores with movement
time frame: At 6, 12, 24, and 36 h after delivery
measure: Severity of nausea/vomiting
time frame: At 6, 12, 24, and 36 h after delivery
measure: Severity of pruritis
time frame: At 6, 12, 24, and 36 h after delivery
measure: Severity of sedation
time frame: At 6, 12, 24, and 36 h after delivery
measure: Time to first request for additional analgesia
time frame: First 36 h after delivery
measure: Patient satisfaction with pain control
time frame: At 24 and 36 h after delivery
measure: Quality of Recovery
time frame: At 24 and 36 h after delivery
measure: Antiemetic consumption
time frame: First 36 h after delivery
measure: Antipruritic medication consumption
time frame: First 36 h after delivery
measure: Total opioid consumption
time frame: First 36 h after delivery
arm group label: Low dose epidural morphine
arm group type: Active Comparator
description: One dose of 1.25 mg epidural morphine
arm group label: High dose epidural morphine
arm group type: Active Comparator
description: One dose of 2.5 mg epidural morphine
arm group label: Saline
arm group type: Placebo Comparator
description: One dose of 10 ml saline administered through an epidural catheter
intervention type: Drug
intervention name: Morphine
description: Comparison of different dosages of drug
arm group label: High dose epidural morphine
arm group label: Low dose epidural morphine
intervention type: Drug
intervention name: Placebo
arm group label: Saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Sudha I Singh, MD FRCPC
role: Principal Investigator
affiliation: The University of Western Ontario
responsible party type: Sponsor
mesh term: Morphine