<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/NCT01715701</url>
  </required_header>
  <id_info>
    <org_study_id>SG2012-003</org_study_id>
    <nct_id>NCT01715701</nct_id>
  </id_info>
  <brief_title>Efficacy of Paravertebral Nerve Blockade to Reduce Pain Following Thoracoscopy</brief_title>
  <official_title>Efficacy of Multilevel Thoracic Paravertebral Nerve Blockade to Reduce Postoperative Pain Following Video-assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche du Centre Hospitalier de l'Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess:&#xD;
&#xD;
        -  The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to&#xD;
           intercostal nerve blockade performed at the end of surgery on the intensity of&#xD;
           postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as&#xD;
           their primary analgesic modality.&#xD;
&#xD;
        -  The incidence of chronic pain at 6 months following video-assisted thoracic surgery.&#xD;
&#xD;
        -  The impact of preoperative multilevel paravertebral nerve blockade on patients' quality&#xD;
           of life at 6 months following surgery compared to intercostal nerve blockade and to a&#xD;
           control group using PCA alone.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
        1. The basic hypothesis of this study is that preoperative thoracic multilevel&#xD;
           paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the&#xD;
           end of surgery will provide superior postoperative analgesia and lower opioid&#xD;
           consumption compared to PCA alone during the first 24 hours following surgery.&#xD;
&#xD;
        2. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence&#xD;
           of chronic pain at 6 months following surgery.&#xD;
&#xD;
        3. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal&#xD;
           nerve blockade performed at the end of surgery will shorten the length of stay in the&#xD;
           intermediate intensive care unit and shorten the hospital stay.&#xD;
&#xD;
        4. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal&#xD;
           nerve blockade performed at the end of surgery will reduce postoperative pulmonary&#xD;
           complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Video-assisted thoracoscopy is increasing in popularity. Although it is considered a less&#xD;
      invasive treatment than thoracotomy, patients have reported moderate to severe pain of&#xD;
      variable duration. Benefits of adequate analgesia no longer need to be demonstrated. Optimal&#xD;
      analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances&#xD;
      patient's satisfaction and quality of life following surgery. Furthermore, adequate&#xD;
      postoperative analgesia may reduce the occurrence of chronic pain. The incidence of chronic&#xD;
      pain following thoracoscopic procedures ranges from 20-47%.&#xD;
&#xD;
      The ideal postoperative analgesia regimen for the pain related to thoracoscopy has not been&#xD;
      elucidated.&#xD;
&#xD;
      Systemic opioids given through patient-controlled devices (PCA) may be used after&#xD;
      thoracoscopic procedures but the analgesic effect can be limited and undesirable side-effects&#xD;
      may occur.&#xD;
&#xD;
      Thoracic epidural has emerged as the preferred pain control technique following thoracotomy.&#xD;
      However, the role of epidural analgesia after thoracoscopy remains debatable. Side-effects&#xD;
      may outweigh the benefits of the technique in the context of minimally invasive surgeries.&#xD;
&#xD;
      Paravertebral blockade is an alternative to epidural analgesia. The duration of pain relief&#xD;
      associated with this technique may vary from 4 to 48 hours. Its effectiveness has been shown&#xD;
      to be equal or superior to that of epidural analgesia for post-thoracotomy pain. Its&#xD;
      popularity for pain management following thoracotomy has promoted its use after thoracoscopic&#xD;
      procedures. Preoperative paravertebral blockade could also result in a reduction of chronic&#xD;
      pain following surgery.&#xD;
&#xD;
      Intercostal nerve blockade is widely used to alleviate pain following thoracoscopy. This&#xD;
      technique is known to provide adequate short-term pain relief.&#xD;
&#xD;
      Both paravertebral and intercostal blocks could be interesting adjuncts to patient-controlled&#xD;
      devices for pain management following thoracoscopic procedures.&#xD;
&#xD;
      This study will compare the efficacy of preoperative paravertebral nerve blockade to&#xD;
      intercostal nerve blockade performed before skin closure to PCA alone to reduce the intensity&#xD;
      of pain following thoracoscopic procedures. All patients will have a PCA device as their&#xD;
      primary analgesic modality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of postoperative pain</measure>
    <time_frame>From arrival in the recovery room until 48 hours following surgery</time_frame>
    <description>Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>From surgery until 48 hours following surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction with pain relief</measure>
    <time_frame>From surgery until 48 hours following surgery</time_frame>
    <description>Patient's satisfaction with pain relief will be assessed using a scale from 1 to 4 (1=very dissatisfied, 4=very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of chronic pain</measure>
    <time_frame>Six months after surgery</time_frame>
    <description>Incidence of chronic pain will be assessed using the Brief Pain Inventory questionnaire (BPI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the recovery room</measure>
    <time_frame>From arrival to discharge from the recovery room (an expected average of one hour)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the intermediate intensive care unit</measure>
    <time_frame>From arrival to discharge from the intermediate intensive care unit (an expected average of one day)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the hospital</measure>
    <time_frame>From surgery to discharge from the hospital (an expected average of 2 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Paravertebral nerve blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intercostal nerve blockade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Controlled Analgesia (PCA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Paravertebral nerve blockade</intervention_name>
    <description>Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.</description>
    <arm_group_label>Paravertebral nerve blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intercostal nerve blockade</intervention_name>
    <description>Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.</description>
    <arm_group_label>Intercostal nerve blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Patient Controlled Analgesia</intervention_name>
    <description>Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.</description>
    <arm_group_label>Patient Controlled Analgesia (PCA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for an elective or emergency thoracoscopic surgery&#xD;
&#xD;
          -  Physical status 1-4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to paravertebral nerve blockade (coagulopathy, sepsis or local&#xD;
             infection at the site of injection, spinal deformity)&#xD;
&#xD;
          -  Severe renal or hepatic insufficiency&#xD;
&#xD;
          -  A known allergy to local anesthetics, morphine or hydromorphone&#xD;
&#xD;
          -  The inability to understand a verbal numerical pain scale (VNPS) despite previous&#xD;
             instruction&#xD;
&#xD;
          -  Preexisting pain at the site of the surgical incision&#xD;
&#xD;
          -  Current use of opioids, anticonvulsants or tricyclic antidepressants&#xD;
&#xD;
          -  A recent history of drug or opioid abuse&#xD;
&#xD;
          -  Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sébastien Garneau, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre hospitalier de l'Université de Montréal (CHUM)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>June 5, 2014</last_update_submitted>
  <last_update_submitted_qc>June 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
  </intervention_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/NCT01715701
org study id: SG2012-003
nct id: NCT01715701
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to assess:

        -  The impact of preoperative multilevel thoracic paravertebral nerve blockade compared to
           intercostal nerve blockade performed at the end of surgery on the intensity of
           postoperative pain in subjects having a Patient Controlled Analgesia (PCA) device as
           their primary analgesic modality.

        -  The incidence of chronic pain at 6 months following video-assisted thoracic surgery.

        -  The impact of preoperative multilevel paravertebral nerve blockade on patients' quality
           of life at 6 months following surgery compared to intercostal nerve blockade and to a
           control group using PCA alone.

      Hypothesis:

        1. The basic hypothesis of this study is that preoperative thoracic multilevel
           paravertebral nerve blockade and multilevel intercostal nerve blockade performed at the
           end of surgery will provide superior postoperative analgesia and lower opioid
           consumption compared to PCA alone during the first 24 hours following surgery.

        2. Preoperative thoracic multilevel paravertebral nerve blockade will reduce the incidence
           of chronic pain at 6 months following surgery.

        3. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal
           nerve blockade performed at the end of surgery will shorten the length of stay in the
           intermediate intensive care unit and shorten the hospital stay.

        4. Preoperative thoracic multilevel paravertebral nerve blockade and multilevel intercostal
           nerve blockade performed at the end of surgery will reduce postoperative pulmonary
           complications.
Video-assisted thoracoscopy is increasing in popularity. Although it is considered a less
      invasive treatment than thoracotomy, patients have reported moderate to severe pain of
      variable duration. Benefits of adequate analgesia no longer need to be demonstrated. Optimal
      analgesia leads to faster recovery, reduces the risk of postoperative complications, enhances
      patient's satisfaction and quality of life following surgery. Furthermore, adequate
      postoperative analgesia may reduce the occurrence of chronic pain. The incidence of chronic
      pain following thoracoscopic procedures ranges from 20-47%.

      The ideal postoperative analgesia regimen for the pain related to thoracoscopy has not been
      elucidated.

      Systemic opioids given through patient-controlled devices (PCA) may be used after
      thoracoscopic procedures but the analgesic effect can be limited and undesirable side-effects
      may occur.

      Thoracic epidural has emerged as the preferred pain control technique following thoracotomy.
      However, the role of epidural analgesia after thoracoscopy remains debatable. Side-effects
      may outweigh the benefits of the technique in the context of minimally invasive surgeries.

      Paravertebral blockade is an alternative to epidural analgesia. The duration of pain relief
      associated with this technique may vary from 4 to 48 hours. Its effectiveness has been shown
      to be equal or superior to that of epidural analgesia for post-thoracotomy pain. Its
      popularity for pain management following thoracotomy has promoted its use after thoracoscopic
      procedures. Preoperative paravertebral blockade could also result in a reduction of chronic
      pain following surgery.

      Intercostal nerve blockade is widely used to alleviate pain following thoracoscopy. This
      technique is known to provide adequate short-term pain relief.

      Both paravertebral and intercostal blocks could be interesting adjuncts to patient-controlled
      devices for pain management following thoracoscopic procedures.

      This study will compare the efficacy of preoperative paravertebral nerve blockade to
      intercostal nerve blockade performed before skin closure to PCA alone to reduce the intensity
      of pain following thoracoscopic procedures. All patients will have a PCA device as their
      primary analgesic modality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Intensity of postoperative pain
time frame: From arrival in the recovery room until 48 hours following surgery
description: Intensity of postoperative pain using a Verbal Numeric Pain Scale (VNPS) upon the patient's arrival in and discharge from the recovery room and daily thereafter, for a total duration of two postoperative days.
measure: Opioid consumption
time frame: From surgery until 48 hours following surgery
measure: Patient's satisfaction with pain relief
time frame: From surgery until 48 hours following surgery
description: Patient's satisfaction with pain relief will be assessed using a scale from 1 to 4 (1=very dissatisfied, 4=very satisfied)
measure: Incidence of chronic pain
time frame: Six months after surgery
description: Incidence of chronic pain will be assessed using the Brief Pain Inventory questionnaire (BPI)
measure: Length of stay in the recovery room
time frame: From arrival to discharge from the recovery room (an expected average of one hour)
measure: Length of stay in the intermediate intensive care unit
time frame: From arrival to discharge from the intermediate intensive care unit (an expected average of one day)
measure: Length of stay in the hospital
time frame: From surgery to discharge from the hospital (an expected average of 2 days)
arm group label: Paravertebral nerve blockade
arm group type: Experimental
description: A multilevel thoracic paravertebral nerve block will be performed by the anaesthesiologist prior to the induction of general anesthesia. Prior to the block, the anaesthesiologist will locate and mark each level and then, infiltrate the skin with lidocaine 2% (0.5-1 mL). Subsequently, using a Tuohy needle 22G, 5 mL of ropivacaine 0.5% will be injected at each level between T4 and T8. At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.
arm group label: Intercostal nerve blockade
arm group type: Active Comparator
description: Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will also infiltrate the skin with lidocaine 2% (0.5-1 mL). A multilevel intercostal nerve block will be performed by the surgeon at the end of surgery before skin closure. Five mL of ropivacaine 0.5% will be injected at each level between T4 and T8. A PCA device will be installed upon arrival in the recovery room.
arm group label: Patient Controlled Analgesia (PCA)
arm group type: Active Comparator
description: Prior to the induction of general anaesthesia, a paravertebral block will be simulated by measuring, marking the patient's skin and applying mild pressure at each level (T4-T8). To preserve the blind, the anaesthesiologist will infiltrate the skin with lidocaine 2% (0.5-1 mL). At the end of surgery, before skin closure, a multilevel intercostal nerve block will be performed by the surgeon using 5 mL of saline at each level between T4-T8. A PCA device will be installed upon arrival in the recovery room.
intervention type: Procedure
intervention name: Paravertebral nerve blockade
description: Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
arm group label: Paravertebral nerve blockade
intervention type: Procedure
intervention name: Intercostal nerve blockade
description: Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.
arm group label: Intercostal nerve blockade
intervention type: Procedure
intervention name: Patient Controlled Analgesia
description: Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
arm group label: Patient Controlled Analgesia (PCA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sébastien Garneau, MD, FRCPC
role: Principal Investigator
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Iodine