<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/NCT03035656</url>
  </required_header>
  <id_info>
    <org_study_id>2016-2380</org_study_id>
    <nct_id>NCT03035656</nct_id>
  </id_info>
  <brief_title>Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion</brief_title>
  <official_title>Effects of Intra-Operative Ropivaciane Epidural Injection on Post-Operative Outcomes Following Elective Lumbar Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Horizon Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Horizon Health Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The following is a double blinded, randomized controlled clinical trial to test the&#xD;
      hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single&#xD;
      intra-operative epidural injection of Ropivaciane® will result in decreased postoperative&#xD;
      pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2)&#xD;
      Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if&#xD;
      there are differences in pain management between MIS and open surgical procedures. The&#xD;
      proposed study will add novel information to current knowledge by 1) exploring of the effects&#xD;
      of intra-operative single epidural injection analgesic on patients receiving MIS compared to&#xD;
      open surgery, and 2) investigate potential immediate and short-term functional improvements&#xD;
      gained from intra-operative single injection of Ropivaciane®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This double blinded, randomized clinical trial will test hypotheses by administering a single&#xD;
      epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical&#xD;
      activities and anesthesia will proceed as usual, with the addition of a single epidural&#xD;
      injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal&#xD;
      level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective&#xD;
      without transient weakness), 9 and the control group will receive 0.9% saline solution (10&#xD;
      ml). Accurate placement into the space will be verified by the injection of contrast medium&#xD;
      (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior&#xD;
      to surgery by pharmacy and coded; surgeons will administer according to the patient's code&#xD;
      maintaining the double-blind procedure. It is important to note that treatment as usual&#xD;
      differs between open and MIS cohorts. The question of interest is whether the addition of the&#xD;
      epidural analgesic to current practices for each surgery type results in increased positive&#xD;
      outcomes, whether this is due to synergistic effects or not. Following operative treatment,&#xD;
      Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically&#xD;
      indicated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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>
    <intervention_model_description>Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain</measure>
    <time_frame>Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively</time_frame>
    <description>Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Disability</measure>
    <time_frame>Administered 6 weeks pre-operatively, 6 and 12 months post-operatively</time_frame>
    <description>Measurement of disability attributed to &quot;back problem&quot; using the validated Oswestry Disability Index (ODI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in General Health</measure>
    <time_frame>Administered 6 weeks pre-operatively, 6 and 12 months post-operatively</time_frame>
    <description>Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Use</measure>
    <time_frame>Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.</time_frame>
    <description>Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Ambulation</measure>
    <time_frame>Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.</time_frame>
    <description>The patient's ability to walk following surgery as measured using Ortho-Care Step Watch Activity Monitors (SAM) which will be attached to the patient's ankle during their stay in hospital.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention</time_frame>
    <description>Adverse Events (AEs) will be measured using the validated Spine Adverse</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">228</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of epidural Ropivaciane</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administration of saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Administration of Ropivaciane via epidural injection intra-operatively</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Administration of saline via epidural injection intra-operatively</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting participants undergoing elective 1-2 level lumbar fusion through the Canada&#xD;
             East Spine Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe respiratory, renal or hepatic disease&#xD;
&#xD;
          -  Previous spine surgery&#xD;
&#xD;
          -  Known allergy to local anaesthesia&#xD;
&#xD;
          -  Those who experience dural tear during operative procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil A Manson, MD FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Edward P Abraham, MD FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erin E Bigney, BA MA</last_name>
    <phone>506 648 6028</phone>
    <email>cescresearch@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eden A Richardson, BA</last_name>
    <phone>506 648 6116</phone>
    <email>Eden.Richardson@Horizonnb.ca</email>
  </overall_contact_backup>
  <reference>
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    <PMID>14633762</PMID>
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    <citation>Luo X, George ML, Kakouras I, Edwards CL, Pietrobon R, Richardson W, Hey L. Reliability, validity, and responsiveness of the short form 12-item survey (SF-12) in patients with back pain. Spine (Phila Pa 1976). 2003 Aug 1;28(15):1739-45. doi: 10.1097/01.BRS.0000083169.58671.96.</citation>
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  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Horizon Health Network</investigator_affiliation>
    <investigator_full_name>Dr. neil Manson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>analgesic</keyword>
  <keyword>spinal fusion</keyword>
  <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>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data will be shared. Study results will be made available following data analysis.</ipd_description>
  </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/NCT03035656
org study id: 2016-2380
nct id: NCT03035656
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The following is a double blinded, randomized controlled clinical trial to test the
      hypothesis that a single epidural injection of Ropivaciane® intra operatively will:1) Single
      intra-operative epidural injection of Ropivaciane® will result in decreased postoperative
      pain and opioid use in both minimally invasive (MIS) and open lumbar fusion patients; 2)
      Decreased postoperative pain will lead to improved clinical outcomes; and 3) Elucidate if
      there are differences in pain management between MIS and open surgical procedures. The
      proposed study will add novel information to current knowledge by 1) exploring of the effects
      of intra-operative single epidural injection analgesic on patients receiving MIS compared to
      open surgery, and 2) investigate potential immediate and short-term functional improvements
      gained from intra-operative single injection of Ropivaciane®.
This double blinded, randomized clinical trial will test hypotheses by administering a single
      epidural injection prior to wound closure of either Ropivaciane® or saline.All pre-surgical
      activities and anesthesia will proceed as usual, with the addition of a single epidural
      injection immediately prior to wound closure 2 levels, or 10cm above the operated spinal
      level. Experimental groups will receive 0.2% Ropivaciane® (10 ml; dose shown to be effective
      without transient weakness), 9 and the control group will receive 0.9% saline solution (10
      ml). Accurate placement into the space will be verified by the injection of contrast medium
      (iohexol, 180 mgl/ml) under fluoroscopic guidance. Epidural solutions will be prepared prior
      to surgery by pharmacy and coded; surgeons will administer according to the patient's code
      maintaining the double-blind procedure. It is important to note that treatment as usual
      differs between open and MIS cohorts. The question of interest is whether the addition of the
      epidural analgesic to current practices for each surgery type results in increased positive
      outcomes, whether this is due to synergistic effects or not. Following operative treatment,
      Foley Urinary catheter will be removed 24 hours post-operatively, unless otherwise clinically
      indicated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized into either the experimental arm (administration of Ropivaciane) or the control arm (administration of saline).
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomization of arms are conducted by the pharmacy department, and drug or saline preparation are prepared by the pharmacy department.
measure: Change in Pain
time frame: Administered 6 weeks pre-operatively, 2, 4, 8, 12, 24 and 48 hours post-operatively, 6 months post operatively, and 12 months post operatively
description: Back and leg pain measured using the validated Numeric Rating Scales (NRS) for back and leg pain.
measure: Change in Disability
time frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
description: Measurement of disability attributed to "back problem" using the validated Oswestry Disability Index (ODI).
measure: Change in General Health
time frame: Administered 6 weeks pre-operatively, 6 and 12 months post-operatively
description: Measurement of overall general health as measured by the validated Short Form General Health Survey (SF-12)
measure: Change in Medication Use
time frame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
description: Medication used to control pain post-operatively as given by a qualified health professional while the patient is in hospital.
measure: Change in Ambulation
time frame: Investigated 2, 4, 8, 12, 24 and 48 hours post-operatively.
description: The patient's ability to walk following surgery as measured using Ortho-Care Step Watch Activity Monitors (SAM) which will be attached to the patient's ankle during their stay in hospital.
measure: Adverse Events
time frame: The total number of adverse events will be measured at the time of patient discharge, between 48 hours and 120 hours following surgical intervention
description: Adverse Events (AEs) will be measured using the validated Spine Adverse
arm group label: Experimental
arm group type: Experimental
description: Administration of epidural Ropivaciane
arm group label: Control
arm group type: Placebo Comparator
description: Administration of saline
intervention type: Drug
intervention name: Ropivacaine
description: Administration of Ropivaciane via epidural injection intra-operatively
arm group label: Experimental
intervention type: Other
intervention name: Saline
description: Administration of saline via epidural injection intra-operatively
arm group label: Control
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Neil A Manson, MD FRCSC
role: Principal Investigator
affiliation: Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
last name: Edward P Abraham, MD FRCSC
role: Principal Investigator
affiliation: Canada East Spine Centre; Horizon Health Network Department of Orthopaedic Surgery; Dalhousie University Faculty of Medicine Department of Surgery
last name: Erin E Bigney, BA MA
phone: 506 648 6028
email: cescresearch@gmail.com
last name: Eden A Richardson, BA
phone: 506 648 6116
email: Eden.Richardson@Horizonnb.ca
citation: Raw DA, Beattie JK, Hunter JM. Anaesthesia for spinal surgery in adults. Br J Anaesth. 2003 Dec;91(6):886-904. doi: 10.1093/bja/aeg253.
PMID: 14633762
citation: Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
PMID: 14667752
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responsible party type: Principal Investigator
investigator affiliation: Horizon Health Network
investigator full name: Dr. neil Manson
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No
ipd description: No individual participant data will be shared. Study results will be made available following data analysis.