<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/NCT02200016</url>
  </required_header>
  <id_info>
    <org_study_id>2014-000707-28</org_study_id>
    <nct_id>NCT02200016</nct_id>
  </id_info>
  <brief_title>Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kolding Sygehus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kolding Sygehus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A&#xD;
      randomized controlled double blinded MRI study comparing long versus short axis catheter&#xD;
      placement. Which procedure for insertion of nerve catheters for postoperative pain after&#xD;
      major foot and ankle surgery is the best&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of nerve catheter displacement</measure>
    <time_frame>48 hours after catheter placement</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid comsumption</measure>
    <time_frame>Within first 48 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of rescue blocks</measure>
    <time_frame>Within 48 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperativ pain after local anesthetic injection via sciatic nerve catheter</measure>
    <time_frame>Within 48 hours postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MR evaluated distribution of local anesthetic after injection MR-contrast</measure>
    <time_frame>48 hours after catheter placement</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Regional Anesthesia</condition>
  <arm_group>
    <arm_group_label>SAX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided short axis (SAX) placement of sciatic nerve catheters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LAX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided long axis (LAX) placement of sciatic nerve catheters</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guided short axis (SAX) placement of sciatic nerve catheters</intervention_name>
    <description>Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.</description>
    <arm_group_label>SAX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guided long axis (LAX) placement of sciatic nerve catheters</intervention_name>
    <description>Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.</description>
    <arm_group_label>LAX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>B Braun Contiplex S catheter</intervention_name>
    <arm_group_label>LAX</arm_group_label>
    <arm_group_label>SAX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 y.&#xD;
&#xD;
          -  Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r&#xD;
&#xD;
          -  Written and informed concent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient uanble to cooperate&#xD;
&#xD;
          -  Patients not speaking and understanding Danish or English&#xD;
&#xD;
          -  Patiens in immunosuppresive treatment&#xD;
&#xD;
          -  Patienter with neuropathys in lower extremities&#xD;
&#xD;
          -  Allergies to the in the protocole listes medicines&#xD;
&#xD;
          -  A daily opoid intake&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patients not meeting MR-criterias (metal, claustofobia...)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesia, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Region Midt</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>di Benedetto P, Casati A, Bertini L, Fanelli G, Chelly JE. Postoperative analgesia with continuous sciatic nerve block after foot surgery: a prospective, randomized comparison between the popliteal and subgluteal approaches. Anesth Analg. 2002 Apr;94(4):996-1000, table of contents. doi: 10.1097/00000539-200204000-00041.</citation>
    <PMID>11916811</PMID>
  </reference>
  <reference>
    <citation>White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.</citation>
    <PMID>14570643</PMID>
  </reference>
  <reference>
    <citation>Tran DQ, Dugani S, Pham K, Al-Shaafi A, Finlayson RJ. A randomized comparison between subepineural and conventional ultrasound-guided popliteal sciatic nerve block. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):548-52. doi: 10.1097/AAP.0b013e318235f566.</citation>
    <PMID>22005661</PMID>
  </reference>
  <reference>
    <citation>Mariano ER, Kim TE, Funck N, Walters T, Wagner MJ, Harrison TK, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of long-and short-axis imaging for in-plane ultrasound-guided femoral perineural catheter insertion. J Ultrasound Med. 2013 Jan;32(1):149-56. doi: 10.7863/jum.2013.32.1.149.</citation>
    <PMID>23269720</PMID>
  </reference>
  <reference>
    <citation>Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.</citation>
    <PMID>24310051</PMID>
  </reference>
  <reference>
    <citation>Marhofer D, Marhofer P, Triffterer L, Leonhardt M, Weber M, Zeitlinger M. Dislocation rates of perineural catheters: a volunteer study. Br J Anaesth. 2013 Nov;111(5):800-6. doi: 10.1093/bja/aet198. Epub 2013 Jun 7.</citation>
    <PMID>23748198</PMID>
  </reference>
  <reference>
    <citation>Niemi-Murola L, Krootila K, Kivisaari R, Kangasmaki A, Kivisaari L, Maunuksela EL. Localization of local anesthetic solution by magnetic resonance imaging. Ophthalmology. 2004 Feb;111(2):342-7. doi: 10.1016/j.ophtha.2003.05.026.</citation>
    <PMID>15019387</PMID>
  </reference>
  <reference>
    <citation>Compere V, Rey N, Baert O, Ouennich A, Fourdrinier V, Roussignol X, Beccari R, Dureuil B. Major complications after 400 continuous popliteal sciatic nerve blocks for post-operative analgesia. Acta Anaesthesiol Scand. 2009 Mar;53(3):339-45. doi: 10.1111/j.1399-6576.2008.01849.x.</citation>
    <PMID>19243320</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Sandhu NS, Loland VJ, Madison SJ, Suresh PJ, Mariano ER, Bishop ML, Schwartz AK, Lee DK. Ultrasound-guided (needle-in-plane) perineural catheter insertion: the effect of catheter-insertion distance on postoperative analgesia. Reg Anesth Pain Med. 2011 May-Jun;36(3):261-5. doi: 10.1097/AAP.0b013e31820f3b80.</citation>
    <PMID>21519311</PMID>
  </reference>
  <reference>
    <citation>Zacchino M, Almolla J, Canepari E, Merico V, Calliada F. Use of ultrasound-magnetic resonance image fusion to guide sacroiliac joint injections: a preliminary assessment. J Ultrasound. 2013 Jul 31;16(3):111-8. doi: 10.1007/s40477-013-0028-7. eCollection 2013 Jul 31.</citation>
    <PMID>24432160</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>June 10, 2015</last_update_submitted>
  <last_update_submitted_qc>June 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kolding Sygehus</investigator_affiliation>
    <investigator_full_name>Rasmus Wulff Hauritz</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Regional anesteshia</keyword>
  <keyword>Nerve catheters</keyword>
  <keyword>Sciatic nerve catheters</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT02200016
org study id: 2014-000707-28
nct id: NCT02200016
lead sponsor: 
collaborator: 
has dmc: Yes
Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A
      randomized controlled double blinded MRI study comparing long versus short axis catheter
      placement. Which procedure for insertion of nerve catheters for postoperative pain after
      major foot and ankle surgery is the best
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Frequency of nerve catheter displacement
time frame: 48 hours after catheter placement
measure: Opioid comsumption
time frame: Within first 48 hours postoperatively
measure: Number of rescue blocks
time frame: Within 48 hours postoperatively
measure: Postoperativ pain after local anesthetic injection via sciatic nerve catheter
time frame: Within 48 hours postoperatively
measure: MR evaluated distribution of local anesthetic after injection MR-contrast
time frame: 48 hours after catheter placement
arm group label: SAX
arm group type: Experimental
description: Ultrasound guided short axis (SAX) placement of sciatic nerve catheters
arm group label: LAX
arm group type: Active Comparator
description: Ultrasound guided long axis (LAX) placement of sciatic nerve catheters
intervention type: Procedure
intervention name: Ultrasound guided short axis (SAX) placement of sciatic nerve catheters
description: Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.
arm group label: SAX
intervention type: Procedure
intervention name: Ultrasound guided long axis (LAX) placement of sciatic nerve catheters
description: Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.
arm group label: LAX
intervention type: Device
intervention name: B Braun Contiplex S catheter
arm group label: LAX
arm group label: SAX
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
citation: di Benedetto P, Casati A, Bertini L, Fanelli G, Chelly JE. Postoperative analgesia with continuous sciatic nerve block after foot surgery: a prospective, randomized comparison between the popliteal and subgluteal approaches. Anesth Analg. 2002 Apr;94(4):996-1000, table of contents. doi: 10.1097/00000539-200204000-00041.
PMID: 11916811
citation: White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.
PMID: 14570643
citation: Tran DQ, Dugani S, Pham K, Al-Shaafi A, Finlayson RJ. A randomized comparison between subepineural and conventional ultrasound-guided popliteal sciatic nerve block. Reg Anesth Pain Med. 2011 Nov-Dec;36(6):548-52. doi: 10.1097/AAP.0b013e318235f566.
PMID: 22005661
citation: Mariano ER, Kim TE, Funck N, Walters T, Wagner MJ, Harrison TK, Giori N, Woolson S, Ganaway T, Howard SK. A randomized comparison of long-and short-axis imaging for in-plane ultrasound-guided femoral perineural catheter insertion. J Ultrasound Med. 2013 Jan;32(1):149-56. doi: 10.7863/jum.2013.32.1.149.
PMID: 23269720
citation: Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.
PMID: 24310051
citation: Marhofer D, Marhofer P, Triffterer L, Leonhardt M, Weber M, Zeitlinger M. Dislocation rates of perineural catheters: a volunteer study. Br J Anaesth. 2013 Nov;111(5):800-6. doi: 10.1093/bja/aet198. Epub 2013 Jun 7.
PMID: 23748198
citation: Niemi-Murola L, Krootila K, Kivisaari R, Kangasmaki A, Kivisaari L, Maunuksela EL. Localization of local anesthetic solution by magnetic resonance imaging. Ophthalmology. 2004 Feb;111(2):342-7. doi: 10.1016/j.ophtha.2003.05.026.
PMID: 15019387
citation: Compere V, Rey N, Baert O, Ouennich A, Fourdrinier V, Roussignol X, Beccari R, Dureuil B. Major complications after 400 continuous popliteal sciatic nerve blocks for post-operative analgesia. Acta Anaesthesiol Scand. 2009 Mar;53(3):339-45. doi: 10.1111/j.1399-6576.2008.01849.x.
PMID: 19243320
citation: Ilfeld BM, Sandhu NS, Loland VJ, Madison SJ, Suresh PJ, Mariano ER, Bishop ML, Schwartz AK, Lee DK. Ultrasound-guided (needle-in-plane) perineural catheter insertion: the effect of catheter-insertion distance on postoperative analgesia. Reg Anesth Pain Med. 2011 May-Jun;36(3):261-5. doi: 10.1097/AAP.0b013e31820f3b80.
PMID: 21519311
citation: Zacchino M, Almolla J, Canepari E, Merico V, Calliada F. Use of ultrasound-magnetic resonance image fusion to guide sacroiliac joint injections: a preliminary assessment. J Ultrasound. 2013 Jul 31;16(3):111-8. doi: 10.1007/s40477-013-0028-7. eCollection 2013 Jul 31.
PMID: 24432160
responsible party type: Principal Investigator
investigator affiliation: Kolding Sygehus
investigator full name: Rasmus Wulff Hauritz
investigator title: Consultant
mesh term: Pain, Postoperative