<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/NCT03750773</url>
  </required_header>
  <id_info>
    <org_study_id>1809661339</org_study_id>
    <nct_id>NCT03750773</nct_id>
  </id_info>
  <brief_title>Gabapentin for Relief of Immediate Postoperative Pain</brief_title>
  <acronym>GRIPP</acronym>
  <official_title>GRIPP: Gabapentin for Relief of Immediate Postoperative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</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 use gabapentin as an additional or alternative treatment for&#xD;
      short term pain control following cesarean delivery in order to reduce the use of opioid pain&#xD;
      medication and improve overall pain control following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, placebo controlled, double blind study. After consent, the subject will&#xD;
      complete a Depression Screening to establish a baseline score. Within 2 hours following&#xD;
      completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin)&#xD;
      or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have&#xD;
      the option to take routine opioid pain medication if her pain is uncontrolled. She will be&#xD;
      asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study&#xD;
      drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For&#xD;
      breastfeeding infants, data will be collected regarding overall feeding quality, somnolence&#xD;
      levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin&#xD;
      level while inpatient and any treatment for this as applicable. The subject will complete the&#xD;
      Depression Scale again at 48 hours following delivery. At one week postpartum, they will&#xD;
      receive a phone call and the following will be addressed: a final pain survey, a Depression&#xD;
      survey, nausea level, number of pain pills left in their prescription, adverse events,&#xD;
      whether or not they would take the study drug again if they should happen to have another&#xD;
      cesarean section, and infant well-being if breastfeeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2, 2019</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total morphine milligram equivalents consumed in the first 48 hours postoperatively</measure>
    <time_frame>48 hours</time_frame>
    <description>The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total morphine milligram equivalents from hospital discharge to one week postoperatively</measure>
    <time_frame>one week</time_frame>
    <description>The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively</measure>
    <time_frame>48 hours</time_frame>
    <description>Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of adverse events potentially associated with study drug (Safety and Tolerability)</measure>
    <time_frame>one week</time_frame>
    <description>Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Subjects receiving gabapentin drug</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving placebo oral capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin 600mg</intervention_name>
    <description>Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.</description>
    <arm_group_label>Subjects receiving gabapentin drug</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.</description>
    <arm_group_label>Subjects receiving placebo oral capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women at least 18 years of age&#xD;
&#xD;
          2. Gestational age &gt; or = to 30 weeks&#xD;
&#xD;
          3. Singleton gestation&#xD;
&#xD;
          4. Women undergoing a non-emergent cesarean delivery&#xD;
&#xD;
          5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean&#xD;
&#xD;
          6. Ability to undergo the informed consent process in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vertical skin incision&#xD;
&#xD;
          2. General anesthesia for cesarean&#xD;
&#xD;
          3. History of major depression or postpartum depression requiring medication&#xD;
&#xD;
          4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or&#xD;
             opioid replacement therapy in the 3 days prior to admission for delivery. This does&#xD;
             not include opioids given for labor anesthesia.&#xD;
&#xD;
          5. Magnesium sulfate treatment postpartum&#xD;
&#xD;
          6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder&#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>David M Haas, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>IUSM, Dept OBGYN</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>David Haas</investigator_full_name>
    <investigator_title>Robert A. Munsick Professor of Obstetrics and Gynecology with Tenure</investigator_title>
  </responsible_party>
  <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>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03750773
org study id: 1809661339
nct id: NCT03750773
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to use gabapentin as an additional or alternative treatment for
      short term pain control following cesarean delivery in order to reduce the use of opioid pain
      medication and improve overall pain control following surgery.
This is a randomized, placebo controlled, double blind study. After consent, the subject will
      complete a Depression Screening to establish a baseline score. Within 2 hours following
      completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin)
      or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have
      the option to take routine opioid pain medication if her pain is uncontrolled. She will be
      asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study
      drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For
      breastfeeding infants, data will be collected regarding overall feeding quality, somnolence
      levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin
      level while inpatient and any treatment for this as applicable. The subject will complete the
      Depression Scale again at 48 hours following delivery. At one week postpartum, they will
      receive a phone call and the following will be addressed: a final pain survey, a Depression
      survey, nausea level, number of pain pills left in their prescription, adverse events,
      whether or not they would take the study drug again if they should happen to have another
      cesarean section, and infant well-being if breastfeeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
measure: Total morphine milligram equivalents consumed in the first 48 hours postoperatively
time frame: 48 hours
description: The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
measure: Total morphine milligram equivalents from hospital discharge to one week postoperatively
time frame: one week
description: The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.
measure: Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
time frame: 48 hours
description: Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.
measure: Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
time frame: one week
description: Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded
arm group label: Subjects receiving gabapentin drug
arm group type: Active Comparator
description: Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean
arm group label: Subjects receiving placebo oral capsule
arm group type: Placebo Comparator
description: Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean
intervention type: Drug
intervention name: Gabapentin 600mg
description: Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
arm group label: Subjects receiving gabapentin drug
intervention type: Drug
intervention name: Placebo oral capsule
description: Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
arm group label: Subjects receiving placebo oral capsule
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David M Haas, MD, MS
role: Principal Investigator
affiliation: IUSM, Dept OBGYN
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: David Haas
investigator title: Robert A. Munsick Professor of Obstetrics and Gynecology with Tenure
mesh term: Pain, Postoperative
mesh term: Gabapentin
sharing ipd: No