<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/NCT01680549</url>
  </required_header>
  <id_info>
    <org_study_id>L12-078</org_study_id>
    <nct_id>NCT01680549</nct_id>
  </id_info>
  <brief_title>Pain Control With Total Knee Replacement</brief_title>
  <acronym>L12-078</acronym>
  <official_title>Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to study the effects of gabapentin on pain control in the&#xD;
      perioperative and post-operative period of total knee arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Being able to understand and better control pain in patients undergoing total knee&#xD;
      arthroplasty will help in many different areas of medicine. Gabapentin is one pain control&#xD;
      modality that has been used by many different orthopaedic surgeons with excellent&#xD;
      retrospective results. Gabapentin, however, has never been studied, to the investigators&#xD;
      knowledge, in a prospective randomized fashion in the United States for total knee&#xD;
      arthroplasty. This study will be the first of its kind to truly compare the effects of&#xD;
      gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo&#xD;
      for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep&#xD;
      quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Pain Scores</measure>
    <time_frame>3 days</time_frame>
    <description>Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.&#xD;
Scale range: 0-100 Higher Values = More Pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Narcotics Consumption</measure>
    <time_frame>3 days</time_frame>
    <description>Narcotics consumption was recorded on postoperative days 0, 1, and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Range of Motion</measure>
    <time_frame>3 days</time_frame>
    <description>Patient knee range of motion was assessed on postoperative days 0, 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Restfulness</measure>
    <time_frame>3 days</time_frame>
    <description>Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Fanatrex</other_name>
    <other_name>Gabarone</other_name>
    <other_name>Gralise</other_name>
    <other_name>Horizant</other_name>
    <other_name>Neurontin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Age &gt; 25 years old&#xD;
&#xD;
               -  Primary osteoarthritis of the knee&#xD;
&#xD;
               -  Must be undergoing unilateral total knee arthroplasty&#xD;
&#xD;
               -  Anesthesia assesment score I, II, or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe joint malalignment (defined as varus/valgus angle &gt; 20 deg)&#xD;
&#xD;
               -  Use of gabapentin pre-operatively&#xD;
&#xD;
               -  History of chronic pain (currently under treatment)&#xD;
&#xD;
               -  History of substance abuse&#xD;
&#xD;
               -  Impaired kidney function (defined as creatinine &gt; 1.5)&#xD;
&#xD;
               -  Epilepsy (currently on medication for treatment)&#xD;
&#xD;
               -  Known allergy to Gabapentin&#xD;
&#xD;
               -  Known history of depression or suicidal thoughts and behaviors&#xD;
&#xD;
               -  Anyone who is not a candidate for general anesthesia or any other portion of the&#xD;
                  investigator's standard of care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George W Brindley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TTUHSC dept. Orthopaedic Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TTUHSC Orthopaedic Surgery MS 9436</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>November 28, 2016</results_first_submitted>
  <results_first_submitted_qc>January 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 17, 2017</results_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2017</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>Gabapentin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gabapentin</title>
          <description>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gabapentin</title>
          <description>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.&#xD;
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days&#xD;
Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="37"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="10.1"/>
                    <measurement group_id="B2" value="63.1" spread="11.2"/>
                    <measurement group_id="B3" value="62.1" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Pain Scores</title>
        <description>Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.&#xD;
Scale range: 0-100 Higher Values = More Pain</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo- Comparator</description>
          </group>
          <group group_id="O2">
            <title>Gabapentin</title>
            <description>Active pain medicine</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Pain Scores</title>
          <description>Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.&#xD;
Scale range: 0-100 Higher Values = More Pain</description>
          <units>units on a scale- VAS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" spread="23.3"/>
                    <measurement group_id="O2" value="40.0" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9" spread="26.6"/>
                    <measurement group_id="O2" value="46.3" spread="30.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" spread="15.9"/>
                    <measurement group_id="O2" value="39.6" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Narcotics Consumption</title>
        <description>Narcotics consumption was recorded on postoperative days 0, 1, and 2.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gabapentin</title>
            <description>Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days</description>
          </group>
        </group_list>
        <measure>
          <title>Narcotics Consumption</title>
          <description>Narcotics consumption was recorded on postoperative days 0, 1, and 2.</description>
          <units>Morphine dose equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.16" spread="9.02"/>
                    <measurement group_id="O2" value="7.40" spread="9.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.53" spread="13.90"/>
                    <measurement group_id="O2" value="25.02" spread="17.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.61" spread="10.78"/>
                    <measurement group_id="O2" value="21.62" spread="17.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knee Range of Motion</title>
        <description>Patient knee range of motion was assessed on postoperative days 0, 1 and 2.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo- comparator</description>
          </group>
          <group group_id="O2">
            <title>Gabapentin</title>
            <description>Active pain control Medicine</description>
          </group>
        </group_list>
        <measure>
          <title>Knee Range of Motion</title>
          <description>Patient knee range of motion was assessed on postoperative days 0, 1 and 2.</description>
          <units>Degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.12" spread="17.72"/>
                    <measurement group_id="O2" value="57.85" spread="17.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.81" spread="20.54"/>
                    <measurement group_id="O2" value="62.74" spread="19.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.47" spread="23.13"/>
                    <measurement group_id="O2" value="65.94" spread="15.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Restfulness</title>
        <description>Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.</description>
        <time_frame>3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo comparator</description>
          </group>
          <group group_id="O2">
            <title>Gabapentin</title>
            <description>Active pain control medicine</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Restfulness</title>
          <description>Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.</description>
          <units>Percent(%) of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3"/>
                    <measurement group_id="O2" value="55.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.9"/>
                    <measurement group_id="O2" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.5"/>
                    <measurement group_id="O2" value="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AE data was collected through the completion of 2 weeks post op visit unless an AE to follow</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>placebo comparator</description>
        </group>
        <group group_id="E2">
          <title>Gabapentin</title>
          <description>Active pain control medicine</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia and vasovagal syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative illeus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Traumatic foley insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nancy Swinford</name_or_title>
      <organization>Texas Tech University Health Sciences Center</organization>
      <phone>806-743-2569</phone>
      <email>nancy.swinford@ttuhsc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01680549
org study id: L12-078
nct id: NCT01680549
lead sponsor: 
has dmc: No
The purpose of this project is to study the effects of gabapentin on pain control in the
      perioperative and post-operative period of total knee arthroplasty.
Being able to understand and better control pain in patients undergoing total knee
      arthroplasty will help in many different areas of medicine. Gabapentin is one pain control
      modality that has been used by many different orthopaedic surgeons with excellent
      retrospective results. Gabapentin, however, has never been studied, to the investigators
      knowledge, in a prospective randomized fashion in the United States for total knee
      arthroplasty. This study will be the first of its kind to truly compare the effects of
      gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo
      for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep
      quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Patient Pain Scores
time frame: 3 days
description: Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.
Scale range: 0-100 Higher Values = More Pain
measure: Narcotics Consumption
time frame: 3 days
description: Narcotics consumption was recorded on postoperative days 0, 1, and 2.
measure: Knee Range of Motion
time frame: 3 days
description: Patient knee range of motion was assessed on postoperative days 0, 1 and 2.
measure: Patient Restfulness
time frame: 3 days
description: Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.
arm group label: Gabapentin
arm group type: Active Comparator
description: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
arm group label: Gabapentin
arm group label: Placebo
other name: Fanatrex
other name: Gabarone
other name: Gralise
other name: Horizant
other name: Neurontin
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: George W Brindley, MD
role: Principal Investigator
affiliation: TTUHSC dept. Orthopaedic Surgery
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Gabapentin
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 