<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/NCT02240199</url>
  </required_header>
  <id_info>
    <org_study_id>PLAN14001</org_study_id>
    <nct_id>NCT02240199</nct_id>
  </id_info>
  <brief_title>Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain</brief_title>
  <acronym>PLAN</acronym>
  <official_title>Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves.&#xD;
      During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy&#xD;
      and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves&#xD;
      eventually become abnormal and provide pain signals to the brain well beyond the healing&#xD;
      period after surgery. Patients with these abnormal nerves suffer from chronic pain in the&#xD;
      breast area that persists for several years after surgery. Chronic pain is associated with a&#xD;
      reduced quality of life, daily functioning, psychological distress, and contributes to&#xD;
      excessive health care expenditures. There is encouraging data suggesting that an infusion of&#xD;
      Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the&#xD;
      development of chronic pain after breast cancer surgery. A large randomized controlled trial&#xD;
      is needed to determine the efficacy of these two interventions on reducing chronic pain after&#xD;
      breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to&#xD;
      determine the feasibility of undertaking such a trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>6 months</time_frame>
    <description>The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-mastectomy pain syndrome</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.</time_frame>
    <description>Most breast cancer surgeries are day procedures, therefore length of hospital stay will be measured based on whether or not the patient was discharged from the hospital on the same day as surgery or if they were admitted and remained in hospital overnight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic Pre-occupation and Coping Scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute postoperative pain</measure>
    <time_frame>Postoperative days 1-9</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Post-mastectomy Pain Syndrome</condition>
  <condition>Chronic Post-surgical Pain</condition>
  <arm_group>
    <arm_group_label>Pregabalin/Lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin Placebo/Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin/Lidocaine Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin Placebo/Lidocaine Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intraoperative Intravenous Lidocaine Infusion</intervention_name>
    <description>Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.</description>
    <arm_group_label>Pregabalin Placebo/Lidocaine</arm_group_label>
    <arm_group_label>Pregabalin/Lidocaine</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perioperative Pregabalin</intervention_name>
    <description>Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.</description>
    <arm_group_label>Pregabalin/Lidocaine</arm_group_label>
    <arm_group_label>Pregabalin/Lidocaine Placebo</arm_group_label>
    <other_name>Lyrica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perioperative Pregabalin Placebo</intervention_name>
    <description>Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.</description>
    <arm_group_label>Pregabalin Placebo/Lidocaine</arm_group_label>
    <arm_group_label>Pregabalin Placebo/Lidocaine Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intraoperative Intravenous Lidocaine Placebo Infusion</intervention_name>
    <description>Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.</description>
    <arm_group_label>Pregabalin Placebo/Lidocaine Placebo</arm_group_label>
    <arm_group_label>Pregabalin/Lidocaine Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patients 18-75 years of age&#xD;
&#xD;
          -  undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast&#xD;
             conserving surgery), for prophylactic (e.g. family history or BRCA gene mutation) or&#xD;
             belief of isolated (non-metastatic) cancerous lesions&#xD;
&#xD;
          -  receiving a general anesthetic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous breast surgery within six months of index surgery&#xD;
&#xD;
          -  undergoing a DIEP (Deep Inferior Epigastric Perforator) flap procedure&#xD;
&#xD;
          -  patient has chronic pain or a chronic pain syndrome for which they have taken 4 or&#xD;
             more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic,&#xD;
             anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve&#xD;
             blocks) during the past 3 months&#xD;
&#xD;
          -  documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine&#xD;
&#xD;
          -  history of ventricular tachycardia, ventricular fibrillation, or atrioventricular&#xD;
             block ≥ type II&#xD;
&#xD;
          -  history of congestive heart failure&#xD;
&#xD;
          -  renal insufficiency with creatinine &gt; 120 µmol/L&#xD;
&#xD;
          -  known or previously documented cirrhosis&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  unable to swallow study medications&#xD;
&#xD;
          -  patient's surgeon believes patient is inappropriate for inclusion in trial&#xD;
&#xD;
          -  unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)&#xD;
&#xD;
          -  language difficulties that would impede valid completion of questionnaires&#xD;
&#xD;
          -  patient requires gabapentin or pregabalin for a medical condition or has been taking&#xD;
             gabapentin or pregabalin daily during the past 1 week&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James S Khan, BHSc, MD</last_name>
    <role>Study Director</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>P.J. Devereaux, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Juravinski Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <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>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>April 20, 2018</last_update_submitted>
  <last_update_submitted_qc>April 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Pregabalin</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/NCT02240199
org study id: PLAN14001
nct id: NCT02240199
lead sponsor: 
collaborator: 
has dmc: No
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves.
      During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy
      and radiotherapy after surgery worsen the injury experienced by these nerves. These nerves
      eventually become abnormal and provide pain signals to the brain well beyond the healing
      period after surgery. Patients with these abnormal nerves suffer from chronic pain in the
      breast area that persists for several years after surgery. Chronic pain is associated with a
      reduced quality of life, daily functioning, psychological distress, and contributes to
      excessive health care expenditures. There is encouraging data suggesting that an infusion of
      Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the
      development of chronic pain after breast cancer surgery. A large randomized controlled trial
      is needed to determine the efficacy of these two interventions on reducing chronic pain after
      breast cancer surgery (e.g. within 3 months of surgery). A pilot trial is first needed to
      determine the feasibility of undertaking such a trial.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Feasibility
time frame: 6 months
description: The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.
measure: Post-mastectomy pain syndrome
time frame: 6 months
measure: Length of hospital stay
time frame: Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
description: Most breast cancer surgeries are day procedures, therefore length of hospital stay will be measured based on whether or not the patient was discharged from the hospital on the same day as surgery or if they were admitted and remained in hospital overnight.
measure: Quality of Life
time frame: 3 months
measure: Somatic Pre-occupation and Coping Scale
time frame: 3 months
measure: Acute postoperative pain
time frame: Postoperative days 1-9
arm group label: Pregabalin/Lidocaine
arm group type: Experimental
description: Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
arm group label: Pregabalin Placebo/Lidocaine
arm group type: Active Comparator
description: Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
arm group label: Pregabalin/Lidocaine Placebo
arm group type: Active Comparator
description: Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
arm group label: Pregabalin Placebo/Lidocaine Placebo
arm group type: Placebo Comparator
description: Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
intervention type: Drug
intervention name: Intraoperative Intravenous Lidocaine Infusion
description: Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
arm group label: Pregabalin Placebo/Lidocaine
arm group label: Pregabalin/Lidocaine
other name: Xylocaine
intervention type: Drug
intervention name: Perioperative Pregabalin
description: Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
arm group label: Pregabalin/Lidocaine
arm group label: Pregabalin/Lidocaine Placebo
other name: Lyrica
intervention type: Drug
intervention name: Perioperative Pregabalin Placebo
description: Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
arm group label: Pregabalin Placebo/Lidocaine
arm group label: Pregabalin Placebo/Lidocaine Placebo
intervention type: Drug
intervention name: Intraoperative Intravenous Lidocaine Placebo Infusion
description: Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
arm group label: Pregabalin Placebo/Lidocaine Placebo
arm group label: Pregabalin/Lidocaine Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: James S Khan, BHSc, MD
role: Study Director
affiliation: Population Health Research Institute
last name: P.J. Devereaux, MD, PhD
role: Principal Investigator
affiliation: Population Health Research Institute
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Lidocaine
mesh term: Pregabalin
sharing ipd: No