<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/NCT02968862</url>
  </required_header>
  <id_info>
    <org_study_id>2010P000602</org_study_id>
    <nct_id>NCT02968862</nct_id>
  </id_info>
  <brief_title>Comparing Analgesia for Postoperative Pain Relief in Spine Surgery</brief_title>
  <official_title>Preemptive Analgesia for Postoperative Pain Relief in Thoraco-lumbo-sacral Spine Surgery: a Double-blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery&#xD;
      involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post&#xD;
      surgical hospital stay of one to three days. These patients will be randomly assigned by the&#xD;
      BWH Investigational Drug Service to one of three different groups, each consisting of 33&#xD;
      patients:&#xD;
&#xD;
      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine&#xD;
      6.25 mg for a total volume of 10 ml.&#xD;
&#xD;
        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a&#xD;
           total volume of 10ml.&#xD;
&#xD;
        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as&#xD;
           the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery&#xD;
      involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post&#xD;
      surgical hospital stay of one to three days. These patients will be randomly assigned by the&#xD;
      BWH Investigational Drug Service to one of three different groups, each consisting of 33&#xD;
      patients:&#xD;
&#xD;
      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine&#xD;
      6.25 mg for a total volume of 10 ml.&#xD;
&#xD;
        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a&#xD;
           total volume of 10ml.&#xD;
&#xD;
        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as&#xD;
           the control group.&#xD;
&#xD;
      Exclusion criteria would be:&#xD;
&#xD;
        1. Anyone unable to sign consent&#xD;
&#xD;
        2. Pregnant patients&#xD;
&#xD;
        3. Non-elective surgery&#xD;
&#xD;
        4. Allergy to any of the study drugs or equipment&#xD;
&#xD;
        5. Any medical condition not compatible with the use of epidural anesthesia such as&#xD;
           multiple sclerosis&#xD;
&#xD;
        6. Any patient with a rash at the surgical site or for cerebrospinal leak repair&#xD;
&#xD;
        7. Any patient who is currently anticoagulated for any reason (drugs or pathologic&#xD;
           condition)&#xD;
&#xD;
        8. Patient who in the opinion of the Investigator may not be a suitable candidate for this&#xD;
           study All subjects will be provided information about the study at their surgical&#xD;
           appointment.&#xD;
&#xD;
      The study coordinator will approach the patient with permission from the surgeon and&#xD;
      introduce the study and one of the co- investigators will explain the study to the patient.&#xD;
&#xD;
      The investigator will subsequently review their eligibility and the inclusion criteria&#xD;
      (thoracolumbar-sacral spine surgery, hospital stay greater than one to three days, and no&#xD;
      history of allergy to local anesthetics or opioids) and the exclusion criteria (documented&#xD;
      allergy, pregnant female, minor, or ongoing cerebrospinal fluid leak coagulation status). If&#xD;
      the subject continues to meet all the criteria, the investigator will explain the study with&#xD;
      the patient and answer all questions. Thereafter, the patients will be provided the consent&#xD;
      forms for their review and a 24/7 contact number for any questions regarding this study.&#xD;
&#xD;
      All patient questions will be answered and informed consent will be obtained by the&#xD;
      investigator at this time. The patient will be provided with contact information. A&#xD;
      co-investigator will be available to answer questions a on a 24-hour basis. It will be&#xD;
      explained to the patient that they will be permitted to withdraw from the study at any time&#xD;
      for any reason until the day of their surgery.&#xD;
&#xD;
      On arrival at the preoperative area, the patient will be assigned a code by one of the&#xD;
      investigators. The BWH Investigational Drug service will be utilized to ensure randomization&#xD;
      and proper preparation and storage of the study drug and the safety of the subjects.&#xD;
&#xD;
      The subjects will be randomized to one of three groups. Subjects will be randomized by the&#xD;
      BWH Investigational Drug Service. The surgeon will be informed of the patient's participation&#xD;
      in the study but not the study group to which they are assigned.&#xD;
&#xD;
      Prior to premedication, all patients will be made familiar with the use of the 10-cm visual&#xD;
      analog scale (VAS), with 0 = no pain, and 10 = worst pain imaginable. The baseline (VAS)&#xD;
      score will be recorded.&#xD;
&#xD;
      All routine standard practices for surgery, anesthesia and perioperative care will be&#xD;
      followed.&#xD;
&#xD;
      All patients will be premedicated with (0.025 - 0.05mg/kg) of midazolam. An epidural will be&#xD;
      placed in the preoperative area by the anesthesiologist.&#xD;
&#xD;
      ■ Patients will be randomized. Patients belonging to Group 1 will receive epidural&#xD;
      hydromorphone 0.5mg and bupivicaine 6.25 mg for a total volume of 10 ml; Group 2 patients&#xD;
      will receive hydromorphone 0.5 mg in preservative free saline for a total volume of 10ml.&#xD;
      Group 3 will receive 10 ml of preservative free saline and this will be the control group.&#xD;
&#xD;
      The epidural will be placed by the anesthesiologist two vertebral levels above the level of&#xD;
      surgery.&#xD;
&#xD;
      A standard total intravenous anesthesia (TIVA) protocol will be followed since somatosensory&#xD;
      and motor evoked potentials are routinely monitored throughout the surgery in these cases.&#xD;
&#xD;
      Anesthesia will be induced with intravenous (IV) propofol (1.5-2.5mg/kg) and fentanyl&#xD;
      (1.0-3.0 ug/kg). Tracheal intubation is facilitated with a neuromuscular blocking drug. The&#xD;
      anesthetic will be maintained with a TIVA technique consisting of propofol and remifentanil&#xD;
      infusions at 0.125 ug/kg/hr for maintenance, dilaudid 0.02-20.mg/kg begin titrating one hour&#xD;
      after incision, with an oxygen/air mixture in 2:1 ratio. A BICS monitor will be used to&#xD;
      monitor depth of anesthesia.&#xD;
&#xD;
      At the completion of the operation, the anesthesiologist will wake-up the patient and the&#xD;
      patient will be transferred to the post anesthesia care unit (PACU).&#xD;
&#xD;
      The postoperative pain, sedation, nausea/vomiting, and constipation scores will be obtained&#xD;
      and recorded by the Study Coordinator. This will be obtained by the visual analog scale (VAS)&#xD;
      (enclosed) every 15 minutes up until 2 hours and on postoperative day one (24 hours). The&#xD;
      type and time for the first demand for supplemental analgesia and the total amount will also&#xD;
      be documented.&#xD;
&#xD;
      The primary endpoints of this study will be to determine the absolute reduction in pain&#xD;
      scores among the groups.&#xD;
&#xD;
      Secondary endpoints would include the overall average pain control scores, the total amount&#xD;
      of postoperative opioid consumption; the degree of opioid side effects for opioid&#xD;
      consumption, the first demand for supplemental analgesia; the time to initial physical&#xD;
      therapy participation, and the return to activities of daily living.&#xD;
&#xD;
      The patients will be assessed by questions that are part of the REDCAP database at their&#xD;
      first post-operative visit about six weeks after their surgery. The questions will ask their&#xD;
      general satisfaction with the study in relation to pain, nausea, vomiting and sedation using&#xD;
      a 0-10 scale either during their post-op visit or by phone if they are not able to return to&#xD;
      the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>low back pain</measure>
    <time_frame>24 hours</time_frame>
    <description>The postoperative pain scores will be obtained and recorded by the Study Coordinator. This will be obtained by the visual analog scale (VAS) (enclosed) every 15 minutes up until 2 hours and on postoperative day one(24 hours). The type and time for the first demand for supplemental analgesia and the total amount will also be documented.</description>
  </primary_outcome>
  <enrollment type="Actual">99</enrollment>
  <condition>Low Back Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational</intervention_name>
    <description>The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post surgical hospital stay of one to three days. These patients will be randomly assigned by the BWH Investigational Drug Service to one of three different groups, each consisting of 33 patients. This is an observational studies with subjects in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive a therapeutic intervention, but the investigator does not assign specific interventions to the subjects of the study.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects will be provided information about the study at their surgical appointment.&#xD;
&#xD;
        The study coordinator will approach the patient with permission from the surgeon and&#xD;
        introduce the study and one of the co- investigators will explain the study to the patient.&#xD;
&#xD;
        The investigator will review their eligibility and the inclusion criteria and the exclusion&#xD;
        criteria. If the subject continues to meet all the criteria, the investigator will explain&#xD;
        the study with the patient and answer all questions. Thereafter, the patients will be&#xD;
        provided the consent forms for their review and a 24/7 contact number for any questions&#xD;
        regarding this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. adult patients&#xD;
&#xD;
          2. 8 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anyone unable to sign consent&#xD;
&#xD;
          2. Pregnant patients&#xD;
&#xD;
          3. Non-elective surgery&#xD;
&#xD;
          4. Allergy to any of the study drugs or equipment&#xD;
&#xD;
          5. Any medical condition not compatible with the use of epidural anesthesia such as&#xD;
             multiple sclerosis&#xD;
&#xD;
          6. Any patient with a rash at the surgical site or for cerebrospinal leak repair&#xD;
&#xD;
          7. Any patient who is currently anticoagulated for any reason (drugs or pathologic&#xD;
             condition)&#xD;
&#xD;
          8. Patient who in the opinion of the Investigator may not be a suitable candidate for&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Linda S Aglio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968862
org study id: 2010P000602
nct id: NCT02968862
lead sponsor: 
has dmc: Yes
The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery
      involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post
      surgical hospital stay of one to three days. These patients will be randomly assigned by the
      BWH Investigational Drug Service to one of three different groups, each consisting of 33
      patients:

      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine
      6.25 mg for a total volume of 10 ml.

        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a
           total volume of 10ml.

        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as
           the control group.
The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery
      involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post
      surgical hospital stay of one to three days. These patients will be randomly assigned by the
      BWH Investigational Drug Service to one of three different groups, each consisting of 33
      patients:

      • Group 1 will be patients that will receive epidural hydromorphone 0. 5mg and bupivicaine
      6.25 mg for a total volume of 10 ml.

        -  Group 2 patients will receive hydromorphone 0.5 mg in preservative free saline for a
           total volume of 10ml.

        -  Group 3 patients will receive 10 ml of preservative free saline and this will serve as
           the control group.

      Exclusion criteria would be:

        1. Anyone unable to sign consent

        2. Pregnant patients

        3. Non-elective surgery

        4. Allergy to any of the study drugs or equipment

        5. Any medical condition not compatible with the use of epidural anesthesia such as
           multiple sclerosis

        6. Any patient with a rash at the surgical site or for cerebrospinal leak repair

        7. Any patient who is currently anticoagulated for any reason (drugs or pathologic
           condition)

        8. Patient who in the opinion of the Investigator may not be a suitable candidate for this
           study All subjects will be provided information about the study at their surgical
           appointment.

      The study coordinator will approach the patient with permission from the surgeon and
      introduce the study and one of the co- investigators will explain the study to the patient.

      The investigator will subsequently review their eligibility and the inclusion criteria
      (thoracolumbar-sacral spine surgery, hospital stay greater than one to three days, and no
      history of allergy to local anesthetics or opioids) and the exclusion criteria (documented
      allergy, pregnant female, minor, or ongoing cerebrospinal fluid leak coagulation status). If
      the subject continues to meet all the criteria, the investigator will explain the study with
      the patient and answer all questions. Thereafter, the patients will be provided the consent
      forms for their review and a 24/7 contact number for any questions regarding this study.

      All patient questions will be answered and informed consent will be obtained by the
      investigator at this time. The patient will be provided with contact information. A
      co-investigator will be available to answer questions a on a 24-hour basis. It will be
      explained to the patient that they will be permitted to withdraw from the study at any time
      for any reason until the day of their surgery.

      On arrival at the preoperative area, the patient will be assigned a code by one of the
      investigators. The BWH Investigational Drug service will be utilized to ensure randomization
      and proper preparation and storage of the study drug and the safety of the subjects.

      The subjects will be randomized to one of three groups. Subjects will be randomized by the
      BWH Investigational Drug Service. The surgeon will be informed of the patient's participation
      in the study but not the study group to which they are assigned.

      Prior to premedication, all patients will be made familiar with the use of the 10-cm visual
      analog scale (VAS), with 0 = no pain, and 10 = worst pain imaginable. The baseline (VAS)
      score will be recorded.

      All routine standard practices for surgery, anesthesia and perioperative care will be
      followed.

      All patients will be premedicated with (0.025 - 0.05mg/kg) of midazolam. An epidural will be
      placed in the preoperative area by the anesthesiologist.

      ■ Patients will be randomized. Patients belonging to Group 1 will receive epidural
      hydromorphone 0.5mg and bupivicaine 6.25 mg for a total volume of 10 ml; Group 2 patients
      will receive hydromorphone 0.5 mg in preservative free saline for a total volume of 10ml.
      Group 3 will receive 10 ml of preservative free saline and this will be the control group.

      The epidural will be placed by the anesthesiologist two vertebral levels above the level of
      surgery.

      A standard total intravenous anesthesia (TIVA) protocol will be followed since somatosensory
      and motor evoked potentials are routinely monitored throughout the surgery in these cases.

      Anesthesia will be induced with intravenous (IV) propofol (1.5-2.5mg/kg) and fentanyl
      (1.0-3.0 ug/kg). Tracheal intubation is facilitated with a neuromuscular blocking drug. The
      anesthetic will be maintained with a TIVA technique consisting of propofol and remifentanil
      infusions at 0.125 ug/kg/hr for maintenance, dilaudid 0.02-20.mg/kg begin titrating one hour
      after incision, with an oxygen/air mixture in 2:1 ratio. A BICS monitor will be used to
      monitor depth of anesthesia.

      At the completion of the operation, the anesthesiologist will wake-up the patient and the
      patient will be transferred to the post anesthesia care unit (PACU).

      The postoperative pain, sedation, nausea/vomiting, and constipation scores will be obtained
      and recorded by the Study Coordinator. This will be obtained by the visual analog scale (VAS)
      (enclosed) every 15 minutes up until 2 hours and on postoperative day one (24 hours). The
      type and time for the first demand for supplemental analgesia and the total amount will also
      be documented.

      The primary endpoints of this study will be to determine the absolute reduction in pain
      scores among the groups.

      Secondary endpoints would include the overall average pain control scores, the total amount
      of postoperative opioid consumption; the degree of opioid side effects for opioid
      consumption, the first demand for supplemental analgesia; the time to initial physical
      therapy participation, and the return to activities of daily living.

      The patients will be assessed by questions that are part of the REDCAP database at their
      first post-operative visit about six weeks after their surgery. The questions will ask their
      general satisfaction with the study in relation to pain, nausea, vomiting and sedation using
      a 0-10 scale either during their post-op visit or by phone if they are not able to return to
      the hospital.
observational model: Cohort
time perspective: Prospective
measure: low back pain
time frame: 24 hours
description: The postoperative pain scores will be obtained and recorded by the Study Coordinator. This will be obtained by the visual analog scale (VAS) (enclosed) every 15 minutes up until 2 hours and on postoperative day one(24 hours). The type and time for the first demand for supplemental analgesia and the total amount will also be documented.
intervention type: Other
intervention name: observational
description: The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post surgical hospital stay of one to three days. These patients will be randomly assigned by the BWH Investigational Drug Service to one of three different groups, each consisting of 33 patients. This is an observational studies with subjects in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive a therapeutic intervention, but the investigator does not assign specific interventions to the subjects of the study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Linda S Aglio
investigator title: Principal Investigator
mesh term: Low Back Pain
mesh term: Pain, Postoperative
sharing ipd: No