<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/NCT03780478</url>
  </required_header>
  <id_info>
    <org_study_id>Rhinoplasty Nerve Block Study</org_study_id>
    <nct_id>NCT03780478</nct_id>
  </id_info>
  <brief_title>Preoperative Nerve Block for Rhinoplasty/Septoplasty</brief_title>
  <official_title>Evaluation of a Preoperative Nerve Block in Pain Scores Following Rhinoplasty/Septoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce&#xD;
      its use or amount prescribed can help mitigate this risk for addiction. Patients undergoing&#xD;
      rhinoplasty are often prescribed a short course of opiates during the acute post surgical&#xD;
      phase. Studies have shown intraoperative sphenopalatine ganglion (SPG) nerve block in&#xD;
      endoscopic sinus surgery can reduce post operative narcotic use. The purpose of this study is&#xD;
      to determine if use of SPG block can be used to reduce narcotic use in the acute post&#xD;
      operative phase of rhinoplasty/septoplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the current opioid epidemic, more than 40,000 deaths can be attributed to prescription&#xD;
      and illicit opioid use per year. There is inherent risk for patients to develop addiction&#xD;
      when prescribing opiates for pain relief, and methods to reduce its use or the amount&#xD;
      prescribed can help mitigate this risk.&#xD;
&#xD;
      Surgery is one of the leading causes for prescribing narcotics to control pain. Patients&#xD;
      undergoing rhinoplasty are often prescribed a short course of opiates during the acute post&#xD;
      surgical phase. Intraoperative sphenopalatine ganglion (SPG) block has been successfully and&#xD;
      safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and&#xD;
      inpatient hospital stay time.&#xD;
&#xD;
      The investigators are interested in determining if use of SPG block may offer an improved&#xD;
      strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. The&#xD;
      investigators hypothesize that SPG block will reduce the amount of post operative opiates&#xD;
      required for pain control.&#xD;
&#xD;
      The study population will include patients undergoing rhinoplasty/septoplasty at Keck Medical&#xD;
      Center of USC who are able to provide consent. The study will include two arms: SPG block&#xD;
      (experimental) and placebo saline injection (control). Patients' post operative pain scale&#xD;
      and narcotic use will be recorded until first follow-up visit (2 weeks). Patient&#xD;
      demographics, surgical indication, and intraoperative analgesia will be recorded. T-tests&#xD;
      will be conducted between patient groups. ANOVA will be used to analyze other factors that&#xD;
      may be associated with decreased narcotic use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 17, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>rhinoplasty/septoplasty patients will be identified by Dr. Kochhar (PI). Patients' informed consent for participation in this study will be obtained and they will subsequently be enrolled. Participants will be randomized into two arms: experimental vs. placebo.&#xD;
Study arms:&#xD;
Experimental: SPG block with local anesthetic per normal methods of nerve block.&#xD;
Placebo: Injection of saline</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>After giving consent to participate in study, patients enrolled in study will be randomly assigned to either the experimental vs. normal standard of care. Patients and members of care team will be unaware as to which group they are assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post op Narcotic Use</measure>
    <time_frame>7 days</time_frame>
    <description>Amount of narcotic use in post operative phase will be recorded until follow up visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post op Numerical pain scale</measure>
    <time_frame>7 days</time_frame>
    <description>Pain scale will be recorded daily until follow up visit. Pain scale is defined as 0-10, where 0 is no pain, and 10 is worst pain ever experienced. Pain score will be obtained daily, and experimental arm will be compared with control arm.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Nasal Fracture</condition>
  <condition>Deviated Nasal Septum</condition>
  <arm_group>
    <arm_group_label>SPG Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sphenopalatine ganglion block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nerve block</intervention_name>
    <description>0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL</description>
    <arm_group_label>SPG Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Saline Injection</intervention_name>
    <description>Saline injection, total volume 2ml</description>
    <arm_group_label>Placebo Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Any patient requiring rhinoplasty/septoplasty and able to provide consent.&#xD;
&#xD;
          2. Must be willing to participate.&#xD;
&#xD;
          3. Must be able to complete consent in English or Spanish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of opioid substance abuse disorder.&#xD;
&#xD;
          2. &lt;18 years old&#xD;
&#xD;
          3. Currently pregnant&#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>
  <overall_official>
    <last_name>Amit Kochhar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>USC Keck Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates</url>
    <description>6) National Institue on Drug Abuse. Overdose Death Rates. NIDA.</description>
  </link>
  <link>
    <url>https://scialert.net/abstract/?doi=jms.2007.1297.1303</url>
    <description>Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery</description>
  </link>
  <reference>
    <citation>Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.</citation>
    <PMID>26370724</PMID>
  </reference>
  <reference>
    <citation>DeMaria S Jr, Govindaraj S, Chinosorvatana N, Kang S, Levine AI. Bilateral sphenopalatine ganglion blockade improves postoperative analgesia after endoscopic sinus surgery. Am J Rhinol Allergy. 2012 Jan-Feb;26(1):e23-7. doi: 10.2500/ajra.2012.26.3709.</citation>
    <PMID>22391074</PMID>
  </reference>
  <reference>
    <citation>Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.</citation>
    <PMID>21739090</PMID>
  </reference>
  <reference>
    <citation>Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034.</citation>
    <PMID>29121158</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 28, 2019</last_update_submitted>
  <last_update_submitted_qc>July 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Amit Kochhar</investigator_full_name>
    <investigator_title>Clinical Assistant Professor of Otolaryngology -Head &amp; Neck Surgery</investigator_title>
  </responsible_party>
  <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/NCT03780478
org study id: Rhinoplasty Nerve Block Study
nct id: NCT03780478
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce
      its use or amount prescribed can help mitigate this risk for addiction. Patients undergoing
      rhinoplasty are often prescribed a short course of opiates during the acute post surgical
      phase. Studies have shown intraoperative sphenopalatine ganglion (SPG) nerve block in
      endoscopic sinus surgery can reduce post operative narcotic use. The purpose of this study is
      to determine if use of SPG block can be used to reduce narcotic use in the acute post
      operative phase of rhinoplasty/septoplasty.
With the current opioid epidemic, more than 40,000 deaths can be attributed to prescription
      and illicit opioid use per year. There is inherent risk for patients to develop addiction
      when prescribing opiates for pain relief, and methods to reduce its use or the amount
      prescribed can help mitigate this risk.

      Surgery is one of the leading causes for prescribing narcotics to control pain. Patients
      undergoing rhinoplasty are often prescribed a short course of opiates during the acute post
      surgical phase. Intraoperative sphenopalatine ganglion (SPG) block has been successfully and
      safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and
      inpatient hospital stay time.

      The investigators are interested in determining if use of SPG block may offer an improved
      strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. The
      investigators hypothesize that SPG block will reduce the amount of post operative opiates
      required for pain control.

      The study population will include patients undergoing rhinoplasty/septoplasty at Keck Medical
      Center of USC who are able to provide consent. The study will include two arms: SPG block
      (experimental) and placebo saline injection (control). Patients' post operative pain scale
      and narcotic use will be recorded until first follow-up visit (2 weeks). Patient
      demographics, surgical indication, and intraoperative analgesia will be recorded. T-tests
      will be conducted between patient groups. ANOVA will be used to analyze other factors that
      may be associated with decreased narcotic use.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: rhinoplasty/septoplasty patients will be identified by Dr. Kochhar (PI). Patients' informed consent for participation in this study will be obtained and they will subsequently be enrolled. Participants will be randomized into two arms: experimental vs. placebo.
Study arms:
Experimental: SPG block with local anesthetic per normal methods of nerve block.
Placebo: Injection of saline
primary purpose: Treatment
masking: Single (Participant)
masking description: After giving consent to participate in study, patients enrolled in study will be randomly assigned to either the experimental vs. normal standard of care. Patients and members of care team will be unaware as to which group they are assigned.
measure: Post op Narcotic Use
time frame: 7 days
description: Amount of narcotic use in post operative phase will be recorded until follow up visit
measure: Post op Numerical pain scale
time frame: 7 days
description: Pain scale will be recorded daily until follow up visit. Pain scale is defined as 0-10, where 0 is no pain, and 10 is worst pain ever experienced. Pain score will be obtained daily, and experimental arm will be compared with control arm.
arm group label: SPG Block
arm group type: Experimental
description: Sphenopalatine ganglion block
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Saline injection
intervention type: Drug
intervention name: Nerve block
description: 0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL
arm group label: SPG Block
intervention type: Drug
intervention name: Placebo Saline Injection
description: Saline injection, total volume 2ml
arm group label: Placebo Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amit Kochhar, MD
role: Principal Investigator
affiliation: USC Keck Medical Center
facility: 
country: United States
url: https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates
description: 6) National Institue on Drug Abuse. Overdose Death Rates. NIDA.
url: https://scialert.net/abstract/?doi=jms.2007.1297.1303
description: Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery
citation: Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.
PMID: 26370724
citation: DeMaria S Jr, Govindaraj S, Chinosorvatana N, Kang S, Levine AI. Bilateral sphenopalatine ganglion blockade improves postoperative analgesia after endoscopic sinus surgery. Am J Rhinol Allergy. 2012 Jan-Feb;26(1):e23-7. doi: 10.2500/ajra.2012.26.3709.
PMID: 22391074
citation: Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8.
PMID: 21739090
citation: Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034.
PMID: 29121158
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Amit Kochhar
investigator title: Clinical Assistant Professor of Otolaryngology -Head & Neck Surgery
sharing ipd: No