xml: <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/NCT05997355</url>
    </required_header>
    <id_info>
      <org_study_id>B3650222</org_study_id>
      <nct_id>NCT05997355</nct_id>
    </id_info>
    <brief_title>Preoperative Gabapentin for Cosmetic Breast Surgery</brief_title>
    <official_title>&quot;Preoperative Gabapentin and Its Effects on Postoperative Analgesia in Patients Undergoing Cosmetic Breast Surgery&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Puerto Rico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Puerto Rico</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare postoperative pain and opioid consumption in&#xD;
        patients who undergo cosmetic breast surgery and are treated preoperatively with gabapentin.&#xD;
        The main questions to answer are the amount of postoperative pain on a scale of 0-10 and&#xD;
        amount of opioids consumed postoperatively. Participants will be randomized into two groups:&#xD;
        treatment vs no treatment. Treatment group will receive 600mg of gabapentin preopreatively.&#xD;
        Researchers will compare treatment vs no treatment group to determine the effects of&#xD;
        preoperative gabapentin on postoperative pain management and opioid consumption.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        HYPOTHESIS We hypothesize that a single dose of preoperative gabapentin will improve&#xD;
        postoperative pain scores and decrease postoperative opioid requirements in our study&#xD;
        population. This will be tested by administering a preoperative dose of 600mg of gabapentin&#xD;
        and measuring pain scores and amount of opioid consumption during the postoperative period.&#xD;
        The study will compare two groups. Participants will be randomly assigned to one of the two&#xD;
        groups and will consist of a treatment group and a control group. We will measure pain scores&#xD;
        in a simple 0-10 scale and amount of opioid consumption during the first 7 days after&#xD;
        discharge and compare them with patients who did not receive preoperative gabapentin. Our&#xD;
        aims are to determine if gabapentin improves postoperative analgesia and reduces&#xD;
        postoperative opioid requirements in a population undergoing cosmetic breast surgery&#xD;
  &#xD;
        METHODOLOGY AND STUDY DESIGN&#xD;
  &#xD;
        This study will be a randomized control trial. Participants will be randomized and divided&#xD;
        into treatment versus no treatment group. Treatment group will be administered a dose of&#xD;
        600mg of gabapentin within 2 hours of surgery. Amount of postoperative opioids will be&#xD;
        measured for 7 days, post op pain scores will be measured twice daily for 7 days. This&#xD;
        information will be collected via postoperative questionnaires.&#xD;
  &#xD;
        STUDY SUBJECTS Participants will be adult, non pregnant patients older than 18 years&#xD;
        undergoing cosmetic breast surgery at either Hospital Oncologico Isaac Gonzalez Martinez or&#xD;
        Hospital UPR Federico Trilla. Participants will be selected during the initial clinic visit,&#xD;
        there will be no specific recruiting strategies. Excluded populations include minors 18 years&#xD;
        old or less as well as pregnant females due to health concerns. Participants will be&#xD;
        explained in detail the goal and objectives of study along with risks vs benefits. The&#xD;
        following HIPAA identifiers will be excluded: Geographical elements, fax numbers, social&#xD;
        security numbers, health insurance beneficiary numbers, vehicle identifiers, digital&#xD;
        identifiers, digital attributes, IP addresses, biometric elements and full face photographic&#xD;
        images.&#xD;
  &#xD;
        VARIABLES&#xD;
  &#xD;
        Primary outcomes will be the amount of postoperative pain and amount of postoperative opioid&#xD;
        consumption. Postoperative pain will be defined and measured as a score from 1-10. Opioid&#xD;
        consumption will be defined and measured as the amount of standard doses used in the&#xD;
        postoperative period. Prior chronic gabapentin or opioid use will also be a variable&#xD;
        accounted for to eliminate confounding effects of tachyphylaxis.&#xD;
  &#xD;
        ANALYTIC PLAN Data will be organized in tables and analyzed with simple t-test to compare&#xD;
        mean pain scores and amount of postoperative opioid consumption. Data will be stored within a&#xD;
        shared google drive folder in a private excel/google sheets document. Each researcher listed&#xD;
        in the study protocol will have access to the data individually via their own electronic&#xD;
        devices in order to access when needed. CO-PI will administer privacy settings and provide&#xD;
        access to each researcher. Data checks will periodically be performed to ensure data&#xD;
        consistency.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Single Group Assignment</intervention_model>
      <intervention_model_description>Treatment with gabapentin vs no treatment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>Days 1-7 postoperatively</time_frame>
      <description>Amount of postoperative pain on a scale from 1-10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative opioid consumption</measure>
      <time_frame>Days 1-7 postoperatively</time_frame>
      <description>Amount of postoperative standardized opioid doses</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient will be treated with preoperative gabapentin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patient will not be treated with preoperative gabapentin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gabapentin 600Mg Tab</intervention_name>
      <description>A single preoperative dose of gabapentin 600mg</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults 18 to 65 y/o without chronic gabapentin and/or opioid use&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  minors less than 18 y/o, adults older than 65 y/o, chronic users of gabapentin and/or&#xD;
               opioids, pregnant females&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Angel Rivera Barrios, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>angel.rivera56@upr.edu</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Miguel A Serpa Irizarry, MD</last_name>
      <phone>7876430397</phone>
      <email>miguel.serpa@upr.edu</email>
    </overall_contact>
    <reference>
      <citation>Chang CY, Challa CK, Shah J, Eloy JD. Gabapentin in acute postoperative pain management. Biomed Res Int. 2014;2014:631756. doi: 10.1155/2014/631756. Epub 2014 Apr 14.</citation>
      <PMID>24829909</PMID>
    </reference>
    <reference>
      <citation>Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.</citation>
      <PMID>16636030</PMID>
    </reference>
    <reference>
      <citation>Liu B, Liu R, Wang L. A meta-analysis of the preoperative use of gabapentinoids for the treatment of acute postoperative pain following spinal surgery. Medicine (Baltimore). 2017 Sep;96(37):e8031. doi: 10.1097/MD.0000000000008031.</citation>
      <PMID>28906391</PMID>
    </reference>
    <reference>
      <citation>Mao Y, Wu L, Ding W. The efficacy of preoperative administration of gabapentin/pregabalin in improving pain after total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Aug 30;17(1):373. doi: 10.1186/s12891-016-1231-4.</citation>
      <PMID>27577678</PMID>
    </reference>
    <reference>
      <citation>Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.</citation>
      <PMID>30519075</PMID>
    </reference>
    <reference>
      <citation>Rai AS, Khan JS, Dhaliwal J, Busse JW, Choi S, Devereaux PJ, Clarke H. Preoperative pregabalin or gabapentin for acute and chronic postoperative pain among patients undergoing breast cancer surgery: A systematic review and meta-analysis of randomized controlled trials. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1317-1328. doi: 10.1016/j.bjps.2017.05.054. Epub 2017 Jun 9.</citation>
      <PMID>28751024</PMID>
    </reference>
    <reference>
      <citation>Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.</citation>
      <PMID>12218520</PMID>
    </reference>
    <reference>
      <citation>Freedman BM, O'Hara E. Pregabalin has opioid-sparing effects following augmentation mammaplasty. Aesthet Surg J. 2008 Jul-Aug;28(4):421-4. doi: 10.1016/j.asj.2008.04.004.</citation>
      <PMID>19083556</PMID>
    </reference>
    <reference>
      <citation>Barker JC, DiBartola K, Wee C, Andonian N, Abdel-Rasoul M, Lowery D, Janis JE. Preoperative Multimodal Analgesia Decreases Postanesthesia Care Unit Narcotic Use and Pain Scores in Outpatient Breast Surgery. Plast Reconstr Surg. 2018 Oct;142(4):443e-450e. doi: 10.1097/PRS.0000000000004804.</citation>
      <PMID>29979365</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Puerto Rico</investigator_affiliation>
      <investigator_full_name>Miguel Serpa Irizarry</investigator_full_name>
      <investigator_title>MD</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>Yes</sharing_ipd>
      <ipd_description>IPD will be made available to other researchers via a private shared online folder.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>During the complete duration of the study</ipd_time_frame>
      <ipd_access_criteria>Researchers will be invited by PI or CO-PI to shared folder. Information will not be shared outside of research group nor made public</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997355
  org study id: B3650222
  nct id: NCT05997355
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare postoperative pain and opioid consumption in
        patients who undergo cosmetic breast surgery and are treated preoperatively with gabapentin.
        The main questions to answer are the amount of postoperative pain on a scale of 0-10 and
        amount of opioids consumed postoperatively. Participants will be randomized into two groups:
        treatment vs no treatment. Treatment group will receive 600mg of gabapentin preopreatively.
        Researchers will compare treatment vs no treatment group to determine the effects of
        preoperative gabapentin on postoperative pain management and opioid consumption.
  HYPOTHESIS We hypothesize that a single dose of preoperative gabapentin will improve
        postoperative pain scores and decrease postoperative opioid requirements in our study
        population. This will be tested by administering a preoperative dose of 600mg of gabapentin
        and measuring pain scores and amount of opioid consumption during the postoperative period.
        The study will compare two groups. Participants will be randomly assigned to one of the two
        groups and will consist of a treatment group and a control group. We will measure pain scores
        in a simple 0-10 scale and amount of opioid consumption during the first 7 days after
        discharge and compare them with patients who did not receive preoperative gabapentin. Our
        aims are to determine if gabapentin improves postoperative analgesia and reduces
        postoperative opioid requirements in a population undergoing cosmetic breast surgery
  
        METHODOLOGY AND STUDY DESIGN
  
        This study will be a randomized control trial. Participants will be randomized and divided
        into treatment versus no treatment group. Treatment group will be administered a dose of
        600mg of gabapentin within 2 hours of surgery. Amount of postoperative opioids will be
        measured for 7 days, post op pain scores will be measured twice daily for 7 days. This
        information will be collected via postoperative questionnaires.
  
        STUDY SUBJECTS Participants will be adult, non pregnant patients older than 18 years
        undergoing cosmetic breast surgery at either Hospital Oncologico Isaac Gonzalez Martinez or
        Hospital UPR Federico Trilla. Participants will be selected during the initial clinic visit,
        there will be no specific recruiting strategies. Excluded populations include minors 18 years
        old or less as well as pregnant females due to health concerns. Participants will be
        explained in detail the goal and objectives of study along with risks vs benefits. The
        following HIPAA identifiers will be excluded: Geographical elements, fax numbers, social
        security numbers, health insurance beneficiary numbers, vehicle identifiers, digital
        identifiers, digital attributes, IP addresses, biometric elements and full face photographic
        images.
  
        VARIABLES
  
        Primary outcomes will be the amount of postoperative pain and amount of postoperative opioid
        consumption. Postoperative pain will be defined and measured as a score from 1-10. Opioid
        consumption will be defined and measured as the amount of standard doses used in the
        postoperative period. Prior chronic gabapentin or opioid use will also be a variable
        accounted for to eliminate confounding effects of tachyphylaxis.
  
        ANALYTIC PLAN Data will be organized in tables and analyzed with simple t-test to compare
        mean pain scores and amount of postoperative opioid consumption. Data will be stored within a
        shared google drive folder in a private excel/google sheets document. Each researcher listed
        in the study protocol will have access to the data individually via their own electronic
        devices in order to access when needed. CO-PI will administer privacy settings and provide
        access to each researcher. Data checks will periodically be performed to ensure data
        consistency.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: Treatment with gabapentin vs no treatment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Postoperative pain
  time frame: Days 1-7 postoperatively
  description: Amount of postoperative pain on a scale from 1-10
  measure: Postoperative opioid consumption
  time frame: Days 1-7 postoperatively
  description: Amount of postoperative standardized opioid doses
  arm group label: Treatment
  arm group type: Experimental
  description: Patient will be treated with preoperative gabapentin
  arm group label: No treatment
  arm group type: No Intervention
  description: Patient will not be treated with preoperative gabapentin
  intervention type: Drug
  intervention name: Gabapentin 600Mg Tab
  description: A single preoperative dose of gabapentin 600mg
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Angel Rivera Barrios, MD
  role: Principal Investigator
  affiliation: angel.rivera56@upr.edu
  last name: Miguel A Serpa Irizarry, MD
  phone: 7876430397
  email: miguel.serpa@upr.edu
  citation: Chang CY, Challa CK, Shah J, Eloy JD. Gabapentin in acute postoperative pain management. Biomed Res Int. 2014;2014:631756. doi: 10.1155/2014/631756. Epub 2014 Apr 14.
  PMID: 24829909
  citation: Seib RK, Paul JE. Preoperative gabapentin for postoperative analgesia: a meta-analysis. Can J Anaesth. 2006 May;53(5):461-9. doi: 10.1007/BF03022618.
  PMID: 16636030
  citation: Liu B, Liu R, Wang L. A meta-analysis of the preoperative use of gabapentinoids for the treatment of acute postoperative pain following spinal surgery. Medicine (Baltimore). 2017 Sep;96(37):e8031. doi: 10.1097/MD.0000000000008031.
  PMID: 28906391
  citation: Mao Y, Wu L, Ding W. The efficacy of preoperative administration of gabapentin/pregabalin in improving pain after total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2016 Aug 30;17(1):373. doi: 10.1186/s12891-016-1231-4.
  PMID: 27577678
  citation: Hu J, Huang D, Li M, Wu C, Zhang J. Effects of a single dose of preoperative pregabalin and gabapentin for acute postoperative pain: a network meta-analysis of randomized controlled trials. J Pain Res. 2018 Nov 2;11:2633-2643. doi: 10.2147/JPR.S170810. eCollection 2018.
  PMID: 30519075
  citation: Rai AS, Khan JS, Dhaliwal J, Busse JW, Choi S, Devereaux PJ, Clarke H. Preoperative pregabalin or gabapentin for acute and chronic postoperative pain among patients undergoing breast cancer surgery: A systematic review and meta-analysis of randomized controlled trials. J Plast Reconstr Aesthet Surg. 2017 Oct;70(10):1317-1328. doi: 10.1016/j.bjps.2017.05.054. Epub 2017 Jun 9.
  PMID: 28751024
  citation: Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4. doi: 10.1097/00000542-200209000-00007.
  PMID: 12218520
  citation: Freedman BM, O'Hara E. Pregabalin has opioid-sparing effects following augmentation mammaplasty. Aesthet Surg J. 2008 Jul-Aug;28(4):421-4. doi: 10.1016/j.asj.2008.04.004.
  PMID: 19083556
  citation: Barker JC, DiBartola K, Wee C, Andonian N, Abdel-Rasoul M, Lowery D, Janis JE. Preoperative Multimodal Analgesia Decreases Postanesthesia Care Unit Narcotic Use and Pain Scores in Outpatient Breast Surgery. Plast Reconstr Surg. 2018 Oct;142(4):443e-450e. doi: 10.1097/PRS.0000000000004804.
  PMID: 29979365
  responsible party type: Principal Investigator
  investigator affiliation: University of Puerto Rico
  investigator full name: Miguel Serpa Irizarry
  investigator title: MD
  mesh term: Pain, Postoperative
  mesh term: Gabapentin
  sharing ipd: Yes
  ipd description: IPD will be made available to other researchers via a private shared online folder.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: During the complete duration of the study
  ipd access criteria: Researchers will be invited by PI or CO-PI to shared folder. Information will not be shared outside of research group nor made public