<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/NCT04416386</url>
  </required_header>
  <id_info>
    <org_study_id>Medipol Hospital 12</org_study_id>
    <nct_id>NCT04416386</nct_id>
  </id_info>
  <brief_title>Vitamin C Level Effect in Orthognathic Surgery</brief_title>
  <official_title>Does Vitamin C Level Effect Postoperative Analgesia in Orthognathic Surgery: a Preliminary Study?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medipol 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>
      Comparing the pre and post-operative blood plasma levels of vitamin C according to oxidative&#xD;
      stress and investigate the correlation between post-operative analgesia requirement and&#xD;
      vitamin C levels following orthognathic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin C (ascorbic acid) is a water-soluble vitamin that has many functions include&#xD;
      antioxidant, neuroprotective, neuromodulator and co-factor for various enzymes or chemical&#xD;
      reactions. Primarily ascorbic acid is the most potent non-enzymatic antioxidant agent in an&#xD;
      extracellular fluid which is crucial for defense against oxidative stress. Recent clinical&#xD;
      studies have shown that trauma or surgery may lead to oxidative stress and plasma vitamin C&#xD;
      level decreases due to body demand that most likely caused by oxidative stress.&#xD;
&#xD;
      Pain is defined as an unpleasant sensory and emotional experience associated with actual or&#xD;
      potential tissue damage. One of the major purposes in the management of post-operative pain&#xD;
      is to minimize the dose of medications to reduce side effects while providing adequate&#xD;
      analgesia.&#xD;
&#xD;
      In orthopedic surgery and management of postherpetic neuralgia oral vitamin C supplementation&#xD;
      significantly reduced pain. However, the decrease in vitamin C concentration,the effects on&#xD;
      antinociception and postoperative pain are not fully understood.&#xD;
&#xD;
      In this study, investigators aimed to compare pre and post-operative blood plasma levels of&#xD;
      vitamin C after orthognathic surgery and investigate a correlation between post-operative&#xD;
      analgesia requirement and vitamin C levels without vitamin C administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Actual">March 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood plasma levels of vitamin C</measure>
    <time_frame>Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours</time_frame>
    <description>Pre and post-operative blood plasma levels of vitamin C</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours</time_frame>
    <description>Postoperative opioid consumption</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Maxillofacial Abnormalities</condition>
  <condition>Maxillofacial Injuries</condition>
  <condition>Maxillofacial Trauma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitamin C</intervention_name>
    <description>Pre and post-operative blood plasma levels of vitamin C will be investigated</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Orthognathic surgery patients aged between 19-38 years (mean age 27.17) with ASA I and ASA&#xD;
        II status will be included in this randomized prospective study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
          -  Scheduled for orthognatic surgery under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of bleeding diathesis,&#xD;
&#xD;
          -  receiving anticoagulant treatment,&#xD;
&#xD;
          -  known local anesthetics and opioid allergy,&#xD;
&#xD;
          -  infection of the skin at the site of the needle puncture,&#xD;
&#xD;
          -  pregnancy or lactation,&#xD;
&#xD;
          -  patients who do not accept the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bagcilar</state>
        <zip>34070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Fukushima R, Yamazaki E. Vitamin C requirement in surgical patients. Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):669-76. doi: 10.1097/MCO.0b013e32833e05bc.</citation>
    <PMID>20689415</PMID>
  </reference>
  <reference>
    <citation>Jeon Y, Park JS, Moon S, Yeo J. Effect of Intravenous High Dose Vitamin C on Postoperative Pain and Morphine Use after Laparoscopic Colectomy: A Randomized Controlled Trial. Pain Res Manag. 2016;2016:9147279. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.</citation>
    <PMID>27872555</PMID>
  </reference>
  <reference>
    <citation>Pirbudak L, Balat O, Cekmen M, Ugur MG, Aygun S, Oner U. Effect of ascorbic acid on surgical stress response in gynecologic surgery. Int J Clin Pract. 2004 Oct;58(10):928-31. doi: 10.1111/j.1742-1241.2004.00022.x.</citation>
    <PMID>15587771</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medipol University</investigator_affiliation>
    <investigator_full_name>Bahadir Ciftci</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maxillofacial Abnormalities</mesh_term>
    <mesh_term>Maxillofacial Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not plan to share IPD</ipd_description>
  </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/NCT04416386
org study id: Medipol Hospital 12
nct id: NCT04416386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparing the pre and post-operative blood plasma levels of vitamin C according to oxidative
      stress and investigate the correlation between post-operative analgesia requirement and
      vitamin C levels following orthognathic surgery.
Vitamin C (ascorbic acid) is a water-soluble vitamin that has many functions include
      antioxidant, neuroprotective, neuromodulator and co-factor for various enzymes or chemical
      reactions. Primarily ascorbic acid is the most potent non-enzymatic antioxidant agent in an
      extracellular fluid which is crucial for defense against oxidative stress. Recent clinical
      studies have shown that trauma or surgery may lead to oxidative stress and plasma vitamin C
      level decreases due to body demand that most likely caused by oxidative stress.

      Pain is defined as an unpleasant sensory and emotional experience associated with actual or
      potential tissue damage. One of the major purposes in the management of post-operative pain
      is to minimize the dose of medications to reduce side effects while providing adequate
      analgesia.

      In orthopedic surgery and management of postherpetic neuralgia oral vitamin C supplementation
      significantly reduced pain. However, the decrease in vitamin C concentration,the effects on
      antinociception and postoperative pain are not fully understood.

      In this study, investigators aimed to compare pre and post-operative blood plasma levels of
      vitamin C after orthognathic surgery and investigate a correlation between post-operative
      analgesia requirement and vitamin C levels without vitamin C administration.
observational model: Case-Control
time perspective: Prospective
measure: Blood plasma levels of vitamin C
time frame: Change from baseline blood plasma levels of vitamin C at postoperative 1, 2, 4, 8, 16 hours
description: Pre and post-operative blood plasma levels of vitamin C
measure: Opioid consumption
time frame: Change from baseline opioid consumption levels at postoperative 1, 2, 4, 8, 16 hours
description: Postoperative opioid consumption
intervention type: Other
intervention name: Vitamin C
description: Pre and post-operative blood plasma levels of vitamin C will be investigated
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 38 Years
facility: 
country: Turkey
citation: Fukushima R, Yamazaki E. Vitamin C requirement in surgical patients. Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):669-76. doi: 10.1097/MCO.0b013e32833e05bc.
PMID: 20689415
citation: Jeon Y, Park JS, Moon S, Yeo J. Effect of Intravenous High Dose Vitamin C on Postoperative Pain and Morphine Use after Laparoscopic Colectomy: A Randomized Controlled Trial. Pain Res Manag. 2016;2016:9147279. doi: 10.1155/2016/9147279. Epub 2016 Oct 30.
PMID: 27872555
citation: Pirbudak L, Balat O, Cekmen M, Ugur MG, Aygun S, Oner U. Effect of ascorbic acid on surgical stress response in gynecologic surgery. Int J Clin Pract. 2004 Oct;58(10):928-31. doi: 10.1111/j.1742-1241.2004.00022.x.
PMID: 15587771
responsible party type: Principal Investigator
investigator affiliation: Medipol University
investigator full name: Bahadir Ciftci
investigator title: Principal Investigator
mesh term: Maxillofacial Abnormalities
mesh term: Maxillofacial Injuries
sharing ipd: No
ipd description: We will not plan to share IPD