xml: <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/NCT05964868</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00020710</org_study_id>
      <nct_id>NCT05964868</nct_id>
    </id_info>
    <brief_title>Efficacy of Liposomal Bupivacaine Post Septorhinoplasty</brief_title>
    <official_title>The Efficacy of Liposomal Bupivacaine in the Management of Post-operative Pain Following Septorhinoplasty: A Double-blinded, Prospective Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jessyka Lighthall</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Milton S. Hershey Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The objective of this study is to determine if there is a difference in post-operative pain&#xD;
        after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia&#xD;
        compared to other standard local anesthetic regimens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical&#xD;
        site after their septorhinoplasty will have better postoperative pain control and require&#xD;
        fewer narcotics by means of a lower MME compared to the placebo group and the group that&#xD;
        receives postoperative 0.25% bupivacaine with 1:200,000 epinephrine.&#xD;
  &#xD;
        This a prospective randomized controlled, double-blind study evaluating the efficacy of&#xD;
        EXPAREL® versus plain bupivacaine HCl and placebo after perinasal injections during&#xD;
        septorhinoplasty procedures. Seventy-two total patients undergoing septorhinoplasty will be&#xD;
        randomly distributed into three groups (20 patients per group) with various postoperative&#xD;
        local anesthesia regimens. All groups will be given standard oral postoperative pain regimens&#xD;
        as prescribed by the primary surgeon, typically consisting of alternating doses of 1000 mg&#xD;
        acetaminophen and 800 mg ibuprofen with oxycodone 5 mg every 6 hours as needed for&#xD;
        breakthrough pain. All three groups will receive the same treatment at the beginning of&#xD;
        surgery with pre-incisional local surgical site injections with perinasal blocks of 1%&#xD;
        lidocaine with 1:100,000 epinephrine. Group one (study group) will receive a five mL&#xD;
        injection of EXPAREL® postoperatively, group two will receive a five mL injection of 0.25%&#xD;
        bupivacaine with 1:200,000 epinephrine postoperatively, and group three will receive a five&#xD;
        mL injection of saline along the surgical site, all in a ring block fashion (see&#xD;
        illustration). This ring block involves nerve blocks to nasal branches of the supratrochlear,&#xD;
        infraorbital, and infratrochlear nerves. This will also be injected into the floor of the&#xD;
        nasal cavity to block branches of the nasopalatine nerve. The remainder of the ring block&#xD;
        targets local infiltration surrounding the nose and injections are over bone. Although there&#xD;
        is a potential risk of diffusion to adjacent cartilage, this risk is predicted to be low.&#xD;
        Their use of postoperative pain medications will then be documented in the immediate&#xD;
        postoperative period in the post-anesthesia care unit (PACU) as well as the following week&#xD;
        postoperatively, every day, for three times a day. All groups will be required to fill&#xD;
        electronic pain journals through RedCap (a HIPPA compliant server) to record consumption of&#xD;
        pain medications and pain levels as reported by visual analog pain scales, the Wong-Baker&#xD;
        FACES pain rating scale, and modified McGill pain questionnaire, all of which are validated&#xD;
        tools for pain assessment. Patients will be subsequently followed over the course of six&#xD;
        months postoperatively with these validated measures, use of pain medication, and by clinical&#xD;
        exam of the nose/injection site including both external and internal nasal exam, palpation of&#xD;
        the nose and cartilage grafts, evaluation static and dynamic function of the nose, and the&#xD;
        presence of any adverse outcomes including but not limited to cartilage graft loss, septal&#xD;
        perforation, synechiae formation, infection, and persistent or worsening nasal obstruction.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>Phase 3</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>This will be a randomized controlled, double-blinded study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>The patient, surgeons, and research team will be blinded to the group that the subject was randomized to. The pharmacy will prepare equivalent drugs for each study group to visually appear similar so that blinding can be maintained. In the event if the patient experiences a concerning or an adverse reaction, the patient, the surgeons and the research team will be immediately unblinded from the study. If unblinding is required, the pharmacy will be notified and then will provide, from the randomization list, information as to which study group the patient was assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine</measure>
      <time_frame>6 months</time_frame>
      <description>Convert amount of opioid ingested to MMEs as an objective measure of post-operative narcotic use</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Different in patient reported outcome measure of subjective pain scores based on a validated visual analog pain scale (subjective measure) between placebo and test drug</measure>
      <time_frame>6 months</time_frame>
      <description>Validated universal pain assessment tool: Wong-Baker pain scale pain questionnaire. Min 0 = no pain to 10 = maximum pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in time to first dose of opioid rescue after surgery between placebo and test drug</measure>
      <time_frame>6 months</time_frame>
      <description>measure the time from leaving surgery to when the first dose of opioid is taken</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in breathing outcomes between placebo and test drug</measure>
      <time_frame>6 months</time_frame>
      <description>NOSE questionnaire minimum 0 no obstruction to 100 complete obstruction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in adverse events/complications between placebo and test drug</measure>
      <time_frame>6 months</time_frame>
      <description>Assess for general adverse events and post-operative complications</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Rhinoplasty</condition>
    <condition>Pain Management</condition>
    <arm_group>
      <arm_group_label>Liposomal Bupivacaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bupivacaine with epinephrine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Saline solution</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Liposomal Bupivacaine</intervention_name>
      <description>Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.</description>
      <arm_group_label>Liposomal Bupivacaine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.25% bupivacaine with 1:200,000 epinephrine</intervention_name>
      <description>Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.</description>
      <arm_group_label>Bupivacaine with epinephrine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo - Saline solution</intervention_name>
      <description>This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.</description>
      <arm_group_label>Saline solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject must be undergoing rhinoplasty or septorhinoplasty surgery&#xD;
  &#xD;
            2. Male or female subjects greater than or equal to 18 years of age&#xD;
  &#xD;
            3. Written informed consent must be obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          2. The subject is a pregnant or lactating 3. Patients have a cognitive impairment 4.&#xD;
          Patient is a prisoner 5. Patients with hypersensitivity to local anesthetics and pain&#xD;
          medications used in the study 6. Patients weighing less than 48 kg 7. Patients&#xD;
          preoperatively taking narcotics for chronic pain 8. Patients with pre-existing painful&#xD;
          conditions (complex regional pain syndrome, fibromyalgia, neuropathy) 9. Patients with&#xD;
          liver dysfunction 10. Patients with increased creatinine (over 1.5 mg/dl) 11. Patients who&#xD;
          have undergone autologous costal cartilage grafting with their rhinoplasty 12. Morbid&#xD;
          obesity (BMI &gt;40)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jessyka Lighthall, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Penn State Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessyka Lighthall, MD</last_name>
      <phone>7175318945</phone>
      <email>jlighthall@pennstatehealth.psu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jessyka Lighthall</name>
        <address>
          <city>Hershey</city>
          <state>Pennsylvania</state>
          <zip>17033</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jessyka Lighthall, MD</last_name>
        <phone>717-531-8945</phone>
        <email>jlighthall@pennstatehealth.psu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
      <investigator_full_name>Jessyka Lighthall</investigator_full_name>
      <investigator_title>Chief, Division of Facial Plastic &amp; Reconstructive Surgery</investigator_title>
    </responsible_party>
    <keyword>Narcotics</keyword>
    <keyword>opioid</keyword>
    <keyword>septorhinoplasty</keyword>
    <keyword>pain</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epinephrine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964868
  org study id: STUDY00020710
  nct id: NCT05964868
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The objective of this study is to determine if there is a difference in post-operative pain
        after septorhinoplasty when long-acting liposomal bupivacaine is used for local anesthesia
        compared to other standard local anesthetic regimens.
  Hypothesis: Patients receiving postoperative liposomal bupivacaine (EXPAREL®) at the surgical
        site after their septorhinoplasty will have better postoperative pain control and require
        fewer narcotics by means of a lower MME compared to the placebo group and the group that
        receives postoperative 0.25% bupivacaine with 1:200,000 epinephrine.
  
        This a prospective randomized controlled, double-blind study evaluating the efficacy of
        EXPAREL® versus plain bupivacaine HCl and placebo after perinasal injections during
        septorhinoplasty procedures. Seventy-two total patients undergoing septorhinoplasty will be
        randomly distributed into three groups (20 patients per group) with various postoperative
        local anesthesia regimens. All groups will be given standard oral postoperative pain regimens
        as prescribed by the primary surgeon, typically consisting of alternating doses of 1000 mg
        acetaminophen and 800 mg ibuprofen with oxycodone 5 mg every 6 hours as needed for
        breakthrough pain. All three groups will receive the same treatment at the beginning of
        surgery with pre-incisional local surgical site injections with perinasal blocks of 1%
        lidocaine with 1:100,000 epinephrine. Group one (study group) will receive a five mL
        injection of EXPAREL® postoperatively, group two will receive a five mL injection of 0.25%
        bupivacaine with 1:200,000 epinephrine postoperatively, and group three will receive a five
        mL injection of saline along the surgical site, all in a ring block fashion (see
        illustration). This ring block involves nerve blocks to nasal branches of the supratrochlear,
        infraorbital, and infratrochlear nerves. This will also be injected into the floor of the
        nasal cavity to block branches of the nasopalatine nerve. The remainder of the ring block
        targets local infiltration surrounding the nose and injections are over bone. Although there
        is a potential risk of diffusion to adjacent cartilage, this risk is predicted to be low.
        Their use of postoperative pain medications will then be documented in the immediate
        postoperative period in the post-anesthesia care unit (PACU) as well as the following week
        postoperatively, every day, for three times a day. All groups will be required to fill
        electronic pain journals through RedCap (a HIPPA compliant server) to record consumption of
        pain medications and pain levels as reported by visual analog pain scales, the Wong-Baker
        FACES pain rating scale, and modified McGill pain questionnaire, all of which are validated
        tools for pain assessment. Patients will be subsequently followed over the course of six
        months postoperatively with these validated measures, use of pain medication, and by clinical
        exam of the nose/injection site including both external and internal nasal exam, palpation of
        the nose and cartilage grafts, evaluation static and dynamic function of the nose, and the
        presence of any adverse outcomes including but not limited to cartilage graft loss, septal
        perforation, synechiae formation, infection, and persistent or worsening nasal obstruction.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This will be a randomized controlled, double-blinded study.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: The patient, surgeons, and research team will be blinded to the group that the subject was randomized to. The pharmacy will prepare equivalent drugs for each study group to visually appear similar so that blinding can be maintained. In the event if the patient experiences a concerning or an adverse reaction, the patient, the surgeons and the research team will be immediately unblinded from the study. If unblinding is required, the pharmacy will be notified and then will provide, from the randomization list, information as to which study group the patient was assigned.
  measure: Differences in postoperative milligram morphine equivalents (MME) used between placebo and liposomal bupivacaine
  time frame: 6 months
  description: Convert amount of opioid ingested to MMEs as an objective measure of post-operative narcotic use
  measure: Different in patient reported outcome measure of subjective pain scores based on a validated visual analog pain scale (subjective measure) between placebo and test drug
  time frame: 6 months
  description: Validated universal pain assessment tool: Wong-Baker pain scale pain questionnaire. Min 0 = no pain to 10 = maximum pain
  measure: Difference in time to first dose of opioid rescue after surgery between placebo and test drug
  time frame: 6 months
  description: measure the time from leaving surgery to when the first dose of opioid is taken
  measure: Difference in breathing outcomes between placebo and test drug
  time frame: 6 months
  description: NOSE questionnaire minimum 0 no obstruction to 100 complete obstruction
  measure: Difference in adverse events/complications between placebo and test drug
  time frame: 6 months
  description: Assess for general adverse events and post-operative complications
  arm group label: Liposomal Bupivacaine
  arm group type: Experimental
  description: This group will receive a one time 5 mL injection of liposomal bupivacaine post-operatively at the surgical site.
  arm group label: Bupivacaine with epinephrine
  arm group type: Active Comparator
  description: This group will receive a one-time 5 mL injection of 0.25% bupivacaine with 1:200,000 epinephrine post-operatively at the surgical site.
  arm group label: Saline solution
  arm group type: Placebo Comparator
  description: This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.
  intervention type: Drug
  intervention name: Liposomal Bupivacaine
  description: Patients will receive post-operative liposomal bupivacaine (EXPAREL®) at the surgical site at the completion of their septorhinoplasty.
  arm group label: Liposomal Bupivacaine
  intervention type: Drug
  intervention name: 0.25% bupivacaine with 1:200,000 epinephrine
  description: Non-liposomal encapsulated bupivacaine at the surgical site at the completion of septorhinoplasty.
  arm group label: Bupivacaine with epinephrine
  intervention type: Other
  intervention name: Placebo - Saline solution
  description: This group will receive a one-time 5 mL injection of saline post-operatively at the surgical site.
  arm group label: Saline solution
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jessyka Lighthall, MD
  role: Principal Investigator
  affiliation: Penn State Health
  last name: Jessyka Lighthall, MD
  phone: 7175318945
  email: jlighthall@pennstatehealth.psu.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Milton S. Hershey Medical Center
  investigator full name: Jessyka Lighthall
  investigator title: Chief, Division of Facial Plastic & Reconstructive Surgery
  mesh term: Epinephrine
  mesh term: Bupivacaine