<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/NCT03036605</url>
  </required_header>
  <id_info>
    <org_study_id>Ataturk University</org_study_id>
    <nct_id>NCT03036605</nct_id>
  </id_info>
  <brief_title>The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery</brief_title>
  <official_title>The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,&#xD;
      prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to&#xD;
      pain, therefore the most common problems after surgery are postoperative pain and anxiety&#xD;
      during removal of the nasal packing. Lots of methods have been tried to control this pain&#xD;
      (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,&#xD;
      local anesthetics infiltration into nasal packing).&#xD;
&#xD;
      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.&#xD;
      Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong&#xD;
      analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces&#xD;
      postoperative nausea and vomiting incidance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic consumption</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>Analgesic consumption first 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative first hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative second hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative 4th hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative 8th hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative 12th hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain score</measure>
    <time_frame>postoperative 24th hour</time_frame>
    <description>Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Nasal Surgery</condition>
  <arm_group>
    <arm_group_label>Group Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Bupivacaine+Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>%0.5 bupivacaine</description>
    <arm_group_label>Group Bupivacaine</arm_group_label>
    <arm_group_label>Group Bupivacaine+Dexamethasone</arm_group_label>
    <other_name>Bupivacaine only</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>8 mg Dexamethasone</description>
    <arm_group_label>Group Bupivacaine+Dexamethasone</arm_group_label>
    <other_name>Bupivacaine plus dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist's physiologic state I-II patients undergoing&#xD;
             nasal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic pain&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  renal or hepatic insufficiency&#xD;
&#xD;
          -  patients on chronic non-steroidal anti-inflammatory medications&#xD;
&#xD;
          -  emergency cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmet Murat Yayik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ataturk University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ataturk University</name>
      <address>
        <city>Erzurum</city>
        <state>Yakutiye</state>
        <zip>25100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Sahin C, Aras HI. Effect on patient anxiety of lidocaine infiltration into nasal packing after septoplasty: prospective, controlled study. J Laryngol Otol. 2015 Aug;129(8):784-7. doi: 10.1017/S0022215115001644. Epub 2015 Jun 29.</citation>
    <PMID>26118324</PMID>
  </reference>
  <reference>
    <citation>Yilmaz S, Kocaman Akbay B, Yildizbas S, Guclu E, Yaman H, Yalcin Sezen G. Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. J Otolaryngol Head Neck Surg. 2010 Aug;39(4):454-7.</citation>
    <PMID>20643015</PMID>
  </reference>
  <reference>
    <citation>De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.</citation>
    <PMID>21799397</PMID>
  </reference>
  <reference>
    <citation>Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.</citation>
    <PMID>28033159</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>June 6, 2017</last_update_submitted>
  <last_update_submitted_qc>June 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>Ahmet Murat Yayik</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>dexamethasone</keyword>
  <keyword>bupivacaine</keyword>
  <keyword>nasal surgery</keyword>
  <keyword>nasal packing</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03036605
org study id: Ataturk University
nct id: NCT03036605
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,
      prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to
      pain, therefore the most common problems after surgery are postoperative pain and anxiety
      during removal of the nasal packing. Lots of methods have been tried to control this pain
      (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,
      local anesthetics infiltration into nasal packing).

      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.
      Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong
      analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces
      postoperative nausea and vomiting incidance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Analgesic consumption
time frame: Postoperative 24 hours
description: Analgesic consumption first 24 hours
measure: Visual analog pain score
time frame: postoperative first hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
measure: Visual analog pain score
time frame: postoperative second hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
measure: Visual analog pain score
time frame: postoperative 4th hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
measure: Visual analog pain score
time frame: postoperative 8th hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
measure: Visual analog pain score
time frame: postoperative 12th hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
measure: Visual analog pain score
time frame: postoperative 24th hour
description: Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
arm group label: Group Bupivacaine
arm group type: Active Comparator
description: 4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides
arm group label: Group Bupivacaine+Dexamethasone
arm group type: Active Comparator
description: 4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides
intervention type: Drug
intervention name: Bupivacaine
description: %0.5 bupivacaine
arm group label: Group Bupivacaine
arm group label: Group Bupivacaine+Dexamethasone
other name: Bupivacaine only
intervention type: Drug
intervention name: Dexamethasone
description: 8 mg Dexamethasone
arm group label: Group Bupivacaine+Dexamethasone
other name: Bupivacaine plus dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ahmet Murat Yayik, MD
role: Principal Investigator
affiliation: Ataturk University
facility: 
country: Turkey
citation: Sahin C, Aras HI. Effect on patient anxiety of lidocaine infiltration into nasal packing after septoplasty: prospective, controlled study. J Laryngol Otol. 2015 Aug;129(8):784-7. doi: 10.1017/S0022215115001644. Epub 2015 Jun 29.
PMID: 26118324
citation: Yilmaz S, Kocaman Akbay B, Yildizbas S, Guclu E, Yaman H, Yalcin Sezen G. Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. J Otolaryngol Head Neck Surg. 2010 Aug;39(4):454-7.
PMID: 20643015
citation: De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PMID: 21799397
citation: Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
PMID: 28033159
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: Ahmet Murat Yayik
investigator title: MD
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Bupivacaine
mesh term: BB 1101
sharing ipd: Undecided