<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/NCT03236051</url>
  </required_header>
  <id_info>
    <org_study_id>2016HR1116</org_study_id>
    <nct_id>NCT03236051</nct_id>
  </id_info>
  <brief_title>Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study</brief_title>
  <official_title>Multimodal Analgesia in Laparoscopic Radical Gastrectomy With Gastric Cancer: a Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JIANG Zhi-Wei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's&#xD;
      wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets'&#xD;
      oral administration on postoperative pain and rehabilitation after laparoscopic radical&#xD;
      gastrectomy for patients with gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain attracts the attention of surgeons, and optimal postoperative pain&#xD;
      management contributes to reducing complications and accelerating postoperative&#xD;
      rehabilitation. Traditionally, the opioids were used for postoperative pain control. However,&#xD;
      the opioids may increase the time to recover bowel function and lead to postoperative ileus.&#xD;
      Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia&#xD;
      after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy&#xD;
      consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and&#xD;
      oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this&#xD;
      strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</primary_completion_date>
  <phase>N/A</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 is a randomized, parallel, controlled, open study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric rating scales (NRS) score with 24 hours after the surgery</measure>
    <time_frame>1 day</time_frame>
    <description>pain evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NRS score after 24 hours postoperatively</measure>
    <time_frame>1 week</time_frame>
    <description>pain evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of remedial treatment</measure>
    <time_frame>1 week</time_frame>
    <description>pain evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first flatus</measure>
    <time_frame>1 week</time_frame>
    <description>Bowel function recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first off-bed activity</measure>
    <time_frame>1 week</time_frame>
    <description>Postoperative activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of off-bed activity per day</measure>
    <time_frame>1 week</time_frame>
    <description>Postoperative activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of off-bed activity per day</measure>
    <time_frame>1 week</time_frame>
    <description>Postoperative activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first semi-liquid diet</measure>
    <time_frame>1 week</time_frame>
    <description>Bowel function recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>1 month</time_frame>
    <description>postoperative length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>1 week</time_frame>
    <description>Inflammatory indicators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interleukin-6 (IL-6)</measure>
    <time_frame>1 week</time_frame>
    <description>Inflammatory indicators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumin</measure>
    <time_frame>1 year</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total protein</measure>
    <time_frame>1 year</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prealbumin</measure>
    <time_frame>1 year</time_frame>
    <description>Nutritional status</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">156</enrollment>
  <condition>Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>multimodal analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received multimodal analgesia after laparoscopic gastrectomy .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCIA analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received PCIA analgesia after laparoscopic gastrectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multimodal analgesia</intervention_name>
    <description>Multimodal analgesia is the name of a procedure or program. Multimodal analgesia doesn't mean different interventions are used. Patients in this group need receive this analgesia program (procedure) instead of one analgesic drug or technology. The program consists of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of oxycodone/paracetamol mixture.</description>
    <arm_group_label>multimodal analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PCIA analgesia</intervention_name>
    <description>PCIA analgesia:patient-controlled intravenous analgesia with tramadol.</description>
    <arm_group_label>PCIA analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Requirements of informed consent and assent of participant, parent or legal guardian&#xD;
             as applicable.&#xD;
&#xD;
          2. Patients underwent laparoscopic radical gastrectomy under general anesthesia and&#xD;
             between the age of 18 and 75 years old without considering sex.&#xD;
&#xD;
          3. American Society of Anesthesiologists (ASA) physical status I-III.&#xD;
&#xD;
          4. Participants can follow the drug doses and visit plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients certified by a doctor that doesn't fit to participate in this study.&#xD;
&#xD;
          2. Patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen,&#xD;
             tramadol etc..&#xD;
&#xD;
          3. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular&#xD;
             disease, or their cardiac function &gt; II (NYHA) patients, patients received coronary&#xD;
             artery bypass grafting (CABG) recently, and patients with severe hypertension&#xD;
             (systolic pressure≥180mmHg or diastolic pressure≥110mmHg).&#xD;
&#xD;
          4. Patients with gastric cancer with distant metastasis.&#xD;
&#xD;
          5. Patients with severe infection, respiratory dysfunction, coagulation disorders, severe&#xD;
             liver and renal dysfunction (Child - Pugh≥ 10; creatinine clearance &lt; 25 ml/min).&#xD;
&#xD;
          6. Patients with suspect or have a history of drug abuse.&#xD;
&#xD;
          7. Pregnancy and lactation women, or have a pregnancy plan within a month after the test&#xD;
             of the subjects (also including male participants).&#xD;
&#xD;
          8. Sponsors or researchers directly involved in the testing or their family members.&#xD;
&#xD;
          9. Patients with conversion, palliative resection.&#xD;
&#xD;
         10. Patients with chronic pain（NRS≥3）or using opioids or NSAIDs before surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jian ZHAO, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gang WANG, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jiang LIU, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Jinling Hospital, Medical School of Nanjing University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
    <phone>8602580860034</phone>
    <email>surgery34@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jian ZHAO, Ph.D.</last_name>
    <phone>8602580860034</phone>
    <email>zhaojiangogo@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jinling Hospital, Medical School of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
      <phone>8602580860034</phone>
      <email>surgery34@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Jian ZHAO, Ph.D.</last_name>
      <phone>8602580860034</phone>
      <email>zhaojiangogo@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Zhi-Wei JIANG, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jian ZHAO, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gang WANG, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jiang LIU, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Qinghong ZHAO, Ph.D.</last_name>
      <email>njzhqh@sina.com</email>
    </contact>
    <investigator>
      <last_name>Baolin WANG, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qinghong ZHAO, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>JIANG Zhi-Wei</investigator_full_name>
    <investigator_title>Vice director of Research Institute of General Surgery</investigator_title>
  </responsible_party>
  <keyword>gastric cancer</keyword>
  <keyword>gastrectomy</keyword>
  <keyword>multimodal analgesia</keyword>
  <keyword>parecoxib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03236051
org study id: 2016HR1116
nct id: NCT03236051
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's
      wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets'
      oral administration on postoperative pain and rehabilitation after laparoscopic radical
      gastrectomy for patients with gastric cancer.
Postoperative pain attracts the attention of surgeons, and optimal postoperative pain
      management contributes to reducing complications and accelerating postoperative
      rehabilitation. Traditionally, the opioids were used for postoperative pain control. However,
      the opioids may increase the time to recover bowel function and lead to postoperative ileus.
      Multimodal analgesia is recommended in recent years, but studies on multimodal analgesia
      after gastrectomy are scarce. In this study, we introduced a multimodal analgesia strategy
      consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and
      oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this
      strategy compared with PCIA analgesia which is used widely for pain after gastrectomy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, parallel, controlled, open study.
primary purpose: Treatment
masking: None (Open Label)
measure: Numeric rating scales (NRS) score with 24 hours after the surgery
time frame: 1 day
description: pain evaluation
measure: NRS score after 24 hours postoperatively
time frame: 1 week
description: pain evaluation
measure: Number of remedial treatment
time frame: 1 week
description: pain evaluation
measure: Time to first flatus
time frame: 1 week
description: Bowel function recovery
measure: Time to first off-bed activity
time frame: 1 week
description: Postoperative activity
measure: Time of off-bed activity per day
time frame: 1 week
description: Postoperative activity
measure: Length of off-bed activity per day
time frame: 1 week
description: Postoperative activity
measure: Time to first semi-liquid diet
time frame: 1 week
description: Bowel function recovery
measure: Postoperative length of stay
time frame: 1 month
description: postoperative length of stay
measure: C-reactive protein (CRP)
time frame: 1 week
description: Inflammatory indicators
measure: interleukin-6 (IL-6)
time frame: 1 week
description: Inflammatory indicators
measure: Albumin
time frame: 1 year
description: Nutritional status
measure: Total protein
time frame: 1 year
description: Nutritional status
measure: Prealbumin
time frame: 1 year
description: Nutritional status
arm group label: multimodal analgesia
arm group type: Experimental
description: Patients received multimodal analgesia after laparoscopic gastrectomy .
arm group label: PCIA analgesia
arm group type: Active Comparator
description: Patients received PCIA analgesia after laparoscopic gastrectomy.
intervention type: Procedure
intervention name: Multimodal analgesia
description: Multimodal analgesia is the name of a procedure or program. Multimodal analgesia doesn't mean different interventions are used. Patients in this group need receive this analgesia program (procedure) instead of one analgesic drug or technology. The program consists of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of oxycodone/paracetamol mixture.
arm group label: multimodal analgesia
intervention type: Procedure
intervention name: PCIA analgesia
description: PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
arm group label: PCIA analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhi-Wei JIANG, Ph.D.
role: Principal Investigator
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Jian ZHAO, Ph.D.
role: Study Director
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Gang WANG, Ph.D.
role: Study Director
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Jiang LIU, M.D.
role: Study Director
affiliation: Jinling Hospital, Medical School of Nanjing University
last name: Zhi-Wei JIANG, Ph.D.
phone: 8602580860034
email: surgery34@163.com
last name: Jian ZHAO, Ph.D.
phone: 8602580860034
email: zhaojiangogo@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: JIANG Zhi-Wei
investigator title: Vice director of Research Institute of General Surgery
mesh term: Stomach Neoplasms
sharing ipd: No