<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/NCT03230565</url>
  </required_header>
  <id_info>
    <org_study_id>41434</org_study_id>
    <nct_id>NCT03230565</nct_id>
  </id_info>
  <brief_title>Continuous Infusions vs Scheduled Bolus Infusions</brief_title>
  <official_title>A Prospective Comparison of Pain and Analgesia in Patients With Continuous Peripheral Nerve Block Catheters Using Continuous Infusion or Scheduled Bolus Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare continuous infusions to bolus infusions and there affect on post-surgical pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional anesthetic techniques are an integral part to many anesthetic approaches, providing&#xD;
      both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia&#xD;
      peripheral nerve blocks have been shown to reduce postoperative pain and improve measures&#xD;
      such as opioid requirements and readiness for discharge. By using a catheter technique for&#xD;
      continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2&#xD;
      and 3, further extending these benefits. Historically these catheters have implemented a&#xD;
      continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved&#xD;
      analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many&#xD;
      institutions have implemented this new protocol for catheter dosing. The beneficial effect of&#xD;
      scheduled bolus dosing has not been studied in all blocks and all surgical procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Comparison of two groups: 1) Continuous infusion group 2) Bolus Infusion group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post-surgical pain</measure>
    <time_frame>2-3 days after surgery</time_frame>
    <description>Patients will rate their pain on a 0-10 scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>2-3 days after surgery</time_frame>
    <description>Pain medications consumed by patients will be collected</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Surgical Procedure, Unspecified</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Continuous Infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermittent Bolus Infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Patient will be given a continuous infusion of local anesthetic.</description>
    <arm_group_label>Continuous Infusion</arm_group_label>
    <other_name>Continuous infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Patient will be given a scheduled intermittent bolus of local anesthetic.</description>
    <arm_group_label>Intermittent Bolus Infusion</arm_group_label>
    <other_name>Bolus Infusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Enrollment will be offered to adult patients with ASA physical status&#xD;
        I, II, or III, presenting for nerve block catheters for post-operative analgesia.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Exclusion criteria will include: pregnancy, incarceration, age &lt;18, BMI&#xD;
        &gt;35, pre-operative opioid use &gt;30 mg morphine equivalents per day, inability to communicate&#xD;
        with investigators by telephone, and pre-existing neuropathy of the operative extremity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Louis-Horn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Jean-Louis Horn</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </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>Ropivacaine</mesh_term>
  </intervention_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/NCT03230565
org study id: 41434
nct id: NCT03230565
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To compare continuous infusions to bolus infusions and there affect on post-surgical pain.
Regional anesthetic techniques are an integral part to many anesthetic approaches, providing
      both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia
      peripheral nerve blocks have been shown to reduce postoperative pain and improve measures
      such as opioid requirements and readiness for discharge. By using a catheter technique for
      continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2
      and 3, further extending these benefits. Historically these catheters have implemented a
      continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved
      analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many
      institutions have implemented this new protocol for catheter dosing. The beneficial effect of
      scheduled bolus dosing has not been studied in all blocks and all surgical procedures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of two groups: 1) Continuous infusion group 2) Bolus Infusion group
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Investigators and participants will be masked to treatment group. Care providers will be necessarily unmasked.
measure: Post-surgical pain
time frame: 2-3 days after surgery
description: Patients will rate their pain on a 0-10 scale
measure: Opioid Consumption
time frame: 2-3 days after surgery
description: Pain medications consumed by patients will be collected
arm group label: Continuous Infusion
arm group type: Active Comparator
description: Local anesthetic medication (Ropivacaine 0.2%) is provided at a continuous basal rate.
arm group label: Intermittent Bolus Infusion
arm group type: Active Comparator
description: Local anesthetic medication (Ropivacaine 0.2%) is provided in scheduled, intermittent boluses.
intervention type: Drug
intervention name: Ropivacaine
description: Patient will be given a continuous infusion of local anesthetic.
arm group label: Continuous Infusion
other name: Continuous infusion
intervention type: Drug
intervention name: Ropivacaine
description: Patient will be given a scheduled intermittent bolus of local anesthetic.
arm group label: Intermittent Bolus Infusion
other name: Bolus Infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean Louis-Horn, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Jean-Louis Horn
investigator title: Professor of Anesthesiology
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No