<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/NCT01733472</url>
  </required_header>
  <id_info>
    <org_study_id>Hip-CPH-2013</org_study_id>
    <secondary_id>Hässleholm2013</secondary_id>
    <nct_id>NCT01733472</nct_id>
  </id_info>
  <brief_title>General or Regional Anesthesia for Hip Surgery</brief_title>
  <official_title>General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether general anaesthesia or regional anaesthesia&#xD;
      is best for patients undergoing Total Hip Arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for&#xD;
      primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two&#xD;
      alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).&#xD;
&#xD;
      General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital&#xD;
      stay (LOS) for patients undergoing total hip arthroplasty (THA).&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      LOS.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
      Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient&#xD;
      meets the discharge criteria from PACU How many patients will need at least one urinary&#xD;
      bladder catheterisation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>Up to 4 days after surgery</time_frame>
    <description>Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Operative Pain</measure>
    <time_frame>from end of surgey until 48 hrs later</time_frame>
    <description>Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time Hrs Until the Patient Meets the Discharge Criteria From PACU</measure>
    <time_frame>12 hrs</time_frame>
    <description>Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>RA-arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GA-arm, remifentanil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GA-arm, remifentanil</intervention_name>
    <description>Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
    <arm_group_label>GA-arm, remifentanil</arm_group_label>
    <other_name>GA: TCI consisting of remifentanil an propofol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RA-arm</intervention_name>
    <description>Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.</description>
    <arm_group_label>RA-arm</arm_group_label>
    <other_name>Regional anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: patients with osteoarthritis scheduled for surgery&#xD;
&#xD;
          -  patients that will require THA&#xD;
&#xD;
          -  patients over 45 yrs and under 85 yrs.&#xD;
&#xD;
          -  patients that understand the given information and are willing to participate in this&#xD;
             study&#xD;
&#xD;
          -  patients who have signed the informed consent document.&#xD;
&#xD;
          -  patients belonging to ASA class I-III.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior surgery to the same hip&#xD;
&#xD;
          -  patients with a history of stroke, neurological or psychiatric disease that&#xD;
             potentially could affect the perception of pain&#xD;
&#xD;
          -  obesity (BMI &gt; 35)&#xD;
&#xD;
          -  active or suspected infection&#xD;
&#xD;
          -  patients taking opioids or steroids&#xD;
&#xD;
          -  patients suffering from rheumatoid arthritis or an immunological depression&#xD;
&#xD;
          -  patients who are allergic to any of the drugs being used in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>46 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Harsten, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Skane</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,</name>
      <address>
        <city>Hässleholm</city>
        <zip>28125</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.</citation>
    <PMID>18211990</PMID>
  </reference>
  <reference>
    <citation>Marsh BJ, Morton NS, White M, Kenny GN. A computer controlled infusion of propofol for induction and maintenance of anaesthesia in children. Can J Anaesth. 1990 May;37(4 Pt 2):S97. No abstract available.</citation>
    <PMID>2361330</PMID>
  </reference>
  <reference>
    <citation>Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.</citation>
    <PMID>9009936</PMID>
  </reference>
  <reference>
    <citation>Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty. Acta Anaesthesiol Scand. 2015 Apr;59(4):542-3. doi: 10.1111/aas.12495. Epub 2015 Mar 3. No abstract available.</citation>
    <PMID>25736216</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>April 7, 2016</results_first_submitted>
  <results_first_submitted_qc>December 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2019</results_first_posted>
  <last_update_submitted>June 10, 2019</last_update_submitted>
  <last_update_submitted_qc>June 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Andreas Harsten</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>anaesthetic techniques</keyword>
  <keyword>subarachnoid</keyword>
  <keyword>analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remifentanil</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>RA-arm</title>
          <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
placebo</description>
        </group>
        <group group_id="P2">
          <title>GA-arm, Remifentanil</title>
          <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RA-arm</title>
          <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
placebo</description>
        </group>
        <group group_id="B2">
          <title>GA-arm, Remifentanil</title>
          <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</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="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="120"/>
          </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="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </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="68" spread="9"/>
                    <measurement group_id="B2" value="66" spread="8"/>
                    <measurement group_id="B3" value="67" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="60"/>
                  </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>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Length of Hospital Stay</title>
        <description>Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged</description>
        <time_frame>Up to 4 days after surgery</time_frame>
        <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
        <group_list>
          <group group_id="O1">
            <title>RA-arm</title>
            <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
placebo</description>
          </group>
          <group group_id="O2">
            <title>GA-arm, Remifentanil</title>
            <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged</description>
          <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="25" upper_limit="45"/>
                    <measurement group_id="O2" value="26" lower_limit="23" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Operative Pain</title>
        <description>Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)</description>
        <time_frame>from end of surgey until 48 hrs later</time_frame>
        <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
        <group_list>
          <group group_id="O1">
            <title>RA-arm</title>
            <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
RA-arm: Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.</description>
          </group>
          <group group_id="O2">
            <title>GA-arm, Remifentanil</title>
            <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
          </group>
        </group_list>
        <measure>
          <title>Post Operative Pain</title>
          <description>Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)</description>
          <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="20" upper_limit="50"/>
                    <measurement group_id="O2" value="25" lower_limit="0" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time Hrs Until the Patient Meets the Discharge Criteria From PACU</title>
        <description>Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria</description>
        <time_frame>12 hrs</time_frame>
        <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
        <group_list>
          <group group_id="O1">
            <title>RA-arm</title>
            <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
RA-arm: Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.</description>
          </group>
          <group group_id="O2">
            <title>GA-arm, Remifentanil</title>
            <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
          </group>
        </group_list>
        <measure>
          <title>Time Hrs Until the Patient Meets the Discharge Criteria From PACU</title>
          <description>Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria</description>
          <population>Two patients in the RA group were excluded because of the conversion to general anaesthesia.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>RA-arm</title>
          <description>RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg&#xD;
placebo</description>
        </group>
        <group group_id="E2">
          <title>GA-arm, Remifentanil</title>
          <description>GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol&#xD;
GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the &quot;Marsh&quot; and &quot;Minto&quot; algorithm</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <description>atrial fibrillation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </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>Andreas Harsten</name_or_title>
      <organization>Region Skane</organization>
      <phone>46708870567</phone>
      <email>andreas.harsten@skane.se</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/NCT01733472
org study id: Hip-CPH-2013
secondary id: Hässleholm2013
nct id: NCT01733472
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether general anaesthesia or regional anaesthesia
      is best for patients undergoing Total Hip Arthroplasty.
A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for
      primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two
      alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).

      General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital
      stay (LOS) for patients undergoing total hip arthroplasty (THA).

      Primary endpoint:

      LOS.

      Secondary endpoints:

      Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient
      meets the discharge criteria from PACU How many patients will need at least one urinary
      bladder catheterisation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Length of Hospital Stay
time frame: Up to 4 days after surgery
description: Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged
measure: Post Operative Pain
time frame: from end of surgey until 48 hrs later
description: Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)
measure: Time Hrs Until the Patient Meets the Discharge Criteria From PACU
time frame: 12 hrs
description: Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria
arm group label: RA-arm
arm group type: Placebo Comparator
description: RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
arm group label: GA-arm, remifentanil
arm group type: Experimental
description: GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
intervention type: Drug
intervention name: GA-arm, remifentanil
description: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
arm group label: GA-arm, remifentanil
other name: GA: TCI consisting of remifentanil an propofol
intervention type: Drug
intervention name: RA-arm
description: Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.
arm group label: RA-arm
other name: Regional anesthesia
criteria: 
gender: All
minimum age: 46 Years
maximum age: 84 Years
healthy volunteers: No
last name: Andreas Harsten, M.D.
role: Principal Investigator
affiliation: Region Skane
facility: 
country: Sweden
citation: Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
PMID: 18211990
citation: Marsh BJ, Morton NS, White M, Kenny GN. A computer controlled infusion of propofol for induction and maintenance of anaesthesia in children. Can J Anaesth. 1990 May;37(4 Pt 2):S97. No abstract available.
PMID: 2361330
citation: Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.
PMID: 9009936
citation: Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty. Acta Anaesthesiol Scand. 2015 Apr;59(4):542-3. doi: 10.1111/aas.12495. Epub 2015 Mar 3. No abstract available.
PMID: 25736216
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Andreas Harsten
investigator title: M.D.
mesh term: Osteoarthritis
mesh term: Remifentanil
mesh term: Propofol
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 