<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/NCT02992028</url>
  </required_header>
  <id_info>
    <org_study_id>HCH 112294-01-201610-01</org_study_id>
    <nct_id>NCT02992028</nct_id>
  </id_info>
  <brief_title>Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair</brief_title>
  <acronym>VITCRCR</acronym>
  <official_title>Randomized Placebo Controlled Trial of Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Himchan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Himchan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the&#xD;
           shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of&#xD;
           rotator cuff tear.&#xD;
&#xD;
           As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the&#xD;
           rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear&#xD;
           annually more than 300,000 have been performed according to US statistics.&#xD;
&#xD;
           Rotator cuff repair is a successful procedure, both objectively and subjectively, with&#xD;
           regard to pain relief and functional outcome.&#xD;
&#xD;
        2. postoperative pain management after rotator cuff repair Shoulder surgeries are&#xD;
           associated with a level of postoperative pain requiring opioid use for several days. The&#xD;
           opioid requirements after shoulder surgery have been reported to be similar to those&#xD;
           required after gastrectomy or thoracotomy, which might cause several opioid-related side&#xD;
           effects, such as nausea and vomiting, pruritus, urinary distention, and constipation.&#xD;
           Although the introduction of arthroscopy has reduced postoperative pain, a considerable&#xD;
           proportion of patients suffer from moderate to severe acute postoperative pain, as its&#xD;
           benefit is typically apparent after a few days. Consequently, proactive pain control is&#xD;
           also required during the first 24-48 h after arthroscopic shoulder surgeries, just like&#xD;
           in open surgeries. Adequate pain management during the immediate postoperative period is&#xD;
           not only important for patient satisfaction and well-being, but also for facilitating&#xD;
           postoperative rehabilitation and preventing persistent postsurgical pain.&#xD;
&#xD;
      Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after&#xD;
      otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to&#xD;
      have anti oxidant action, and fewer side effects.&#xD;
&#xD;
      However, there is no report about the analgesic effect of vitamin C after arthroscopic&#xD;
      rotator cuff repair.&#xD;
&#xD;
      The purpose of this trial was to compare the effects of a intravenous vitamin C injection on&#xD;
      postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator&#xD;
      cuff repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue scale</measure>
    <time_frame>Recorded at 24 hours after surgery</time_frame>
    <description>from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative narcotic consumption</measure>
    <time_frame>up to postoperative 24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Intravenous vitamin C injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the first 30 min after beginning of the rotator cuff repair, treatment group received infusion of 3 g vitamin C (ascorbic acid) in 500 ml of Ringer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous saline injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Nutrition (Vitamins) injection</intervention_name>
    <arm_group_label>Intravenous vitamin C injection</arm_group_label>
    <other_name>Preoperative Vitamin C injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Saline injection</intervention_name>
    <arm_group_label>Intravenous saline injection</arm_group_label>
    <other_name>Preoperative Saline injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Rotator cuff tear patients undergoing arthroscopic rotator cuff tear&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;45 or &gt;80&#xD;
&#xD;
          -  allergies to medications used in the study&#xD;
&#xD;
          -  history of renal diseases, a coagulation abnormality, a hepatic disease, or drug abuse&#xD;
&#xD;
          -  definite radiographic evidence of osteoarthritis of the glenohumeral joint&#xD;
&#xD;
          -  inflammatory arthritis including rheumatoid arthritis&#xD;
&#xD;
          -  a history of acute trauma&#xD;
&#xD;
          -  systemic conditions associated with chronic pain&#xD;
&#xD;
          -  a history of infection&#xD;
&#xD;
          -  an inability to understand the questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Wan Park, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Himchan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ji Wan Park, M.D.</last_name>
    <phone>+82-1090082712</phone>
    <email>wonkeepark@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Himchan Hopital</name>
      <address>
        <city>Seoul</city>
        <zip>01459</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Wan Park, M.D.</last_name>
      <phone>+82-1090082712</phone>
      <email>wonkeepark@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Sadeghpour A, Alizadehasl A, Kyavar M, Sadeghi T, Moludi J, Gholizadeh F, Totonchi Z, Ghadrdoost B. Impact of vitamin C supplementation on post-cardiac surgery ICU and hospital length of stay. Anesth Pain Med. 2015 Feb 19;5(1):e25337. doi: 10.5812/aapm.25337. eCollection 2015 Feb.</citation>
    <PMID>25789244</PMID>
  </reference>
  <reference>
    <citation>Jo CH, Shin JS, Huh J. Multimodal analgesia for arthroscopic rotator cuff repair: a randomized, placebo-controlled, double-blind trial. Eur J Orthop Surg Traumatol. 2014 Apr;24(3):315-22. doi: 10.1007/s00590-013-1208-z. Epub 2013 Mar 14.</citation>
    <PMID>23494779</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>Ayatollahi V, Dehghanpour Farashah S, Behdad S, Vaziribozorg S, Rabbani Anari M. Effect of intravenous vitamin C on postoperative pain in uvulopalatopharyngoplasty with tonsillectomy. Clin Otolaryngol. 2017 Feb;42(1):139-143. doi: 10.1111/coa.12684. Epub 2016 Jun 7.</citation>
    <PMID>27219124</PMID>
  </reference>
  <reference>
    <citation>Hasanzadeh Kiabi F, Soleimani A, Habibi MR, Emami Zeydi A. Can vitamin C be used as an adjuvant for managing postoperative pain? A short literature review. Korean J Pain. 2013 Apr;26(2):209-10. doi: 10.3344/kjp.2013.26.2.209. Epub 2013 Apr 3. No abstract available.</citation>
    <PMID>23614091</PMID>
  </reference>
  <reference>
    <citation>Coghlan JA, Forbes A, Bell SN, Buchbinder R. Efficacy and safety of a subacromial continuous ropivacaine infusion for post-operative pain management following arthroscopic rotator cuff surgery: a protocol for a randomised double-blind placebo-controlled trial. BMC Musculoskelet Disord. 2008 Apr 22;9:56. doi: 10.1186/1471-2474-9-56.</citation>
    <PMID>18430210</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 10, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 10, 2016</last_update_submitted>
  <last_update_submitted_qc>December 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Himchan Hospital</investigator_affiliation>
    <investigator_full_name>Ji Wan Park</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Rotator cuff repair</keyword>
  <keyword>Vitamin C</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02992028
org study id: HCH 112294-01-201610-01
nct id: NCT02992028
lead sponsor: 
has dmc: No
1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the
           shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of
           rotator cuff tear.

           As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the
           rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear
           annually more than 300,000 have been performed according to US statistics.

           Rotator cuff repair is a successful procedure, both objectively and subjectively, with
           regard to pain relief and functional outcome.

        2. postoperative pain management after rotator cuff repair Shoulder surgeries are
           associated with a level of postoperative pain requiring opioid use for several days. The
           opioid requirements after shoulder surgery have been reported to be similar to those
           required after gastrectomy or thoracotomy, which might cause several opioid-related side
           effects, such as nausea and vomiting, pruritus, urinary distention, and constipation.
           Although the introduction of arthroscopy has reduced postoperative pain, a considerable
           proportion of patients suffer from moderate to severe acute postoperative pain, as its
           benefit is typically apparent after a few days. Consequently, proactive pain control is
           also required during the first 24-48 h after arthroscopic shoulder surgeries, just like
           in open surgeries. Adequate pain management during the immediate postoperative period is
           not only important for patient satisfaction and well-being, but also for facilitating
           postoperative rehabilitation and preventing persistent postsurgical pain.

      Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after
      otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to
      have anti oxidant action, and fewer side effects.

      However, there is no report about the analgesic effect of vitamin C after arthroscopic
      rotator cuff repair.

      The purpose of this trial was to compare the effects of a intravenous vitamin C injection on
      postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator
      cuff repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual analogue scale
time frame: Recorded at 24 hours after surgery
description: from 0mm to 100mm in 10-mm increments (indicating no pain or extreme pain)
measure: Postoperative narcotic consumption
time frame: up to postoperative 24 hours
arm group label: Intravenous vitamin C injection
arm group type: Experimental
description: During the first 30 min after beginning of the rotator cuff repair, treatment group received infusion of 3 g vitamin C (ascorbic acid) in 500 ml of Ringer.
arm group label: Intravenous saline injection
arm group type: Placebo Comparator
description: During the first 30 min after beginning of the rotator cuff repair, sham group received 6 ml normal saline in 500 ml of Ringer.
intervention type: Drug
intervention name: Intravenous Nutrition (Vitamins) injection
arm group label: Intravenous vitamin C injection
other name: Preoperative Vitamin C injection
intervention type: Drug
intervention name: Intravenous Saline injection
arm group label: Intravenous saline injection
other name: Preoperative Saline injection
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ji Wan Park, M.D.
role: Study Chair
affiliation: Himchan Hospital
last name: Ji Wan Park, M.D.
phone: +82-1090082712
email: wonkeepark@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Sadeghpour A, Alizadehasl A, Kyavar M, Sadeghi T, Moludi J, Gholizadeh F, Totonchi Z, Ghadrdoost B. Impact of vitamin C supplementation on post-cardiac surgery ICU and hospital length of stay. Anesth Pain Med. 2015 Feb 19;5(1):e25337. doi: 10.5812/aapm.25337. eCollection 2015 Feb.
PMID: 25789244
citation: Jo CH, Shin JS, Huh J. Multimodal analgesia for arthroscopic rotator cuff repair: a randomized, placebo-controlled, double-blind trial. Eur J Orthop Surg Traumatol. 2014 Apr;24(3):315-22. doi: 10.1007/s00590-013-1208-z. Epub 2013 Mar 14.
PMID: 23494779
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: Ayatollahi V, Dehghanpour Farashah S, Behdad S, Vaziribozorg S, Rabbani Anari M. Effect of intravenous vitamin C on postoperative pain in uvulopalatopharyngoplasty with tonsillectomy. Clin Otolaryngol. 2017 Feb;42(1):139-143. doi: 10.1111/coa.12684. Epub 2016 Jun 7.
PMID: 27219124
citation: Hasanzadeh Kiabi F, Soleimani A, Habibi MR, Emami Zeydi A. Can vitamin C be used as an adjuvant for managing postoperative pain? A short literature review. Korean J Pain. 2013 Apr;26(2):209-10. doi: 10.3344/kjp.2013.26.2.209. Epub 2013 Apr 3. No abstract available.
PMID: 23614091
citation: Coghlan JA, Forbes A, Bell SN, Buchbinder R. Efficacy and safety of a subacromial continuous ropivacaine infusion for post-operative pain management following arthroscopic rotator cuff surgery: a protocol for a randomised double-blind placebo-controlled trial. BMC Musculoskelet Disord. 2008 Apr 22;9:56. doi: 10.1186/1471-2474-9-56.
PMID: 18430210
responsible party type: Principal Investigator
investigator affiliation: Himchan Hospital
investigator full name: Ji Wan Park
investigator title: Director
mesh term: Pain, Postoperative
mesh term: Rotator Cuff Injuries
mesh term: Vitamins