xml: <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/NCT06024200</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2023-327</org_study_id>
      <nct_id>NCT06024200</nct_id>
    </id_info>
    <brief_title>Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery</brief_title>
    <official_title>Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanfang Hospital, Southern Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous&#xD;
        electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic&#xD;
        surgery. All subjects received conventional multimodal analgesia. On this basis, the&#xD;
        experimental group received whole-process transcutaneous electrical acupoint stimulation,&#xD;
        while the control group received corresponding false stimulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Conventional multimodal analgesia protocols as follows：&#xD;
  &#xD;
          1. Before the end of the operation, the surgical incision was infiltrated with 0.5%&#xD;
             ropivacaine 10 mL locally.&#xD;
  &#xD;
          2. Patients were transferred to the PACU and provided with patient-controlled intravenous&#xD;
             analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to&#xD;
             a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL&#xD;
             bolus，without an infusion dose. The pump was withdrawn 72h after surgery.&#xD;
  &#xD;
          3. Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 2, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The total sufentanil consumption postoperatively</measure>
      <time_frame>3 days</time_frame>
      <description>measured from the recovery area until postoperative day 3</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The number of postoperative rescue analgesia</measure>
      <time_frame>7 days</time_frame>
      <description>measured from the recovery area until discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain scores (VAS)</measure>
      <time_frame>4 days</time_frame>
      <description>measured by Visual Analogue Scale( VAS ), which is a scale created in the range of 0 to 10 cm. According to the scale, 0 cm means no pain, and 10 cm means unbearable pain. On the scale, 1 to 3 cm indicates mild pain, 4 to 6 cm indicates moderate pain, and 7 to 10 cm indicates severe pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Catastrophizing</measure>
      <time_frame>5 days</time_frame>
      <description>measured by Pain Catastrophizing Scale（PCS）, which contains 13 items in three dimensions: rumination, magnification, and helplessness. Patients can answer on a 0-to-4 likert scale (0 = &quot;not at all&quot; and 4 = &quot;all the time&quot;). PCS scores range from 0 to 52, and the higher the score,the higher the frequency of catastrophizing cognitions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of recovery</measure>
      <time_frame>5 days</time_frame>
      <description>measured by Quality of Recovery (QoR)-15 questionnaire, which consists of 15 questions distributed on two dimensions: &quot;physical&quot; and &quot;mental&quot; well-being. The patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time), where negatively loaded questions are reversed. This gives a maximum score = 150.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The variation of C-reactive protein（CRP）</measure>
      <time_frame>3 days</time_frame>
      <description>the values of C-reactive protein from peripheral blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procalcitonin（PCT）</measure>
      <time_frame>3 days</time_frame>
      <description>the values of procalcitonin from peripheral blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The variation of white blood cell count （WBC）</measure>
      <time_frame>3 days</time_frame>
      <description>the values of white blood cell count from peripheral blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neutrophil ratio（NEUT）</measure>
      <time_frame>3 days</time_frame>
      <description>neutrophil ratio from peripheral blood</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first ambulation</measure>
      <time_frame>up to 7 days</time_frame>
      <description>time to first ambulation in hours is used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first flatus</measure>
      <time_frame>up to 7 days</time_frame>
      <description>time to first flatus in hours is used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first defecation</measure>
      <time_frame>7 days</time_frame>
      <description>time to first defecation in hours is used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first feed</measure>
      <time_frame>up to 7 days</time_frame>
      <description>time to first feed in hours is used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of adverse reaction</measure>
      <time_frame>7 days</time_frame>
      <description>adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction score with pain management</measure>
      <time_frame>7 days</time_frame>
      <description>measured by 5-point Likert scale, &quot;1&quot; represents very dissatisfied while &quot;5&quot; represents very satisfied</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Transcutaneous Electrical Acupoint Stimulation</condition>
    <arm_group>
      <arm_group_label>whole-process transcutaneous electrical acupoint stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>whole-process transcutaneous electrical acupoint stimulation(sham stimulation)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>transcutaneous electrical acupoint stimulation</intervention_name>
      <description>Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.</description>
      <arm_group_label>whole-process transcutaneous electrical acupoint stimulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>transcutaneous electrical acupoint stimulation sham stimulation</intervention_name>
      <description>Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.</description>
      <arm_group_label>whole-process transcutaneous electrical acupoint stimulation(sham stimulation)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  aged 18 years or older;&#xD;
  &#xD;
            -  scheduled for elective laparoscopic gastrointestinal surgery；&#xD;
  &#xD;
            -  informed consent；&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status Grades I-III；&#xD;
  &#xD;
            -  body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  local skin infection, incision or scar near the study acupoints;&#xD;
  &#xD;
            -  nerve damage in upper or lower limbs;&#xD;
  &#xD;
            -  participation in other clinical trials that influence the evaluation of the results of&#xD;
               this study;&#xD;
  &#xD;
            -  inability to understand the Visual Analog Scale (VAS) score or disagreeing with the&#xD;
               use of patient controlled analgesia;&#xD;
  &#xD;
            -  presence of a pacemaker;&#xD;
  &#xD;
            -  patients with severe CNS diseases or severe mental disorders;&#xD;
  &#xD;
            -  operations requiring enterostomy or converts to laparotomy;&#xD;
  &#xD;
            -  patients who need to be transferred to the intensive care unit (ICU) for treatment&#xD;
               after surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guoxin Li, M.D.,Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guoxin Li, M.D.,Ph.D.</last_name>
      <phone>+86 13802771450</phone>
      <email>gzliguoxin@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fang Qin, MS.N.</last_name>
      <phone>+86 15018410013</phone>
      <email>qf_smu@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nanfang Hospital, Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510-515</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guoxin Li, M.D.,Ph.D.</last_name>
        <phone>+8613802771450</phone>
        <email>gzliguoxin@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024200
  org study id: NFEC-2023-327
  nct id: NCT06024200
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous
        electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic
        surgery. All subjects received conventional multimodal analgesia. On this basis, the
        experimental group received whole-process transcutaneous electrical acupoint stimulation,
        while the control group received corresponding false stimulation.
  Conventional multimodal analgesia protocols as follows：
  
          1. Before the end of the operation, the surgical incision was infiltrated with 0.5%
             ropivacaine 10 mL locally.
  
          2. Patients were transferred to the PACU and provided with patient-controlled intravenous
             analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to
             a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL
             bolus，without an infusion dose. The pump was withdrawn 72h after surgery.
  
          3. Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: The total sufentanil consumption postoperatively
  time frame: 3 days
  description: measured from the recovery area until postoperative day 3
  measure: The number of postoperative rescue analgesia
  time frame: 7 days
  description: measured from the recovery area until discharge
  measure: Pain scores (VAS)
  time frame: 4 days
  description: measured by Visual Analogue Scale( VAS ), which is a scale created in the range of 0 to 10 cm. According to the scale, 0 cm means no pain, and 10 cm means unbearable pain. On the scale, 1 to 3 cm indicates mild pain, 4 to 6 cm indicates moderate pain, and 7 to 10 cm indicates severe pain.
  measure: Pain Catastrophizing
  time frame: 5 days
  description: measured by Pain Catastrophizing Scale（PCS）, which contains 13 items in three dimensions: rumination, magnification, and helplessness. Patients can answer on a 0-to-4 likert scale (0 = "not at all" and 4 = "all the time"). PCS scores range from 0 to 52, and the higher the score,the higher the frequency of catastrophizing cognitions.
  measure: Quality of recovery
  time frame: 5 days
  description: measured by Quality of Recovery (QoR)-15 questionnaire, which consists of 15 questions distributed on two dimensions: "physical" and "mental" well-being. The patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time), where negatively loaded questions are reversed. This gives a maximum score = 150.
  measure: The variation of C-reactive protein（CRP）
  time frame: 3 days
  description: the values of C-reactive protein from peripheral blood
  measure: Procalcitonin（PCT）
  time frame: 3 days
  description: the values of procalcitonin from peripheral blood
  measure: The variation of white blood cell count （WBC）
  time frame: 3 days
  description: the values of white blood cell count from peripheral blood
  measure: Neutrophil ratio（NEUT）
  time frame: 3 days
  description: neutrophil ratio from peripheral blood
  measure: Time to first ambulation
  time frame: up to 7 days
  description: time to first ambulation in hours is used
  measure: Time to first flatus
  time frame: up to 7 days
  description: time to first flatus in hours is used
  measure: Time to first defecation
  time frame: 7 days
  description: time to first defecation in hours is used
  measure: Time to first feed
  time frame: up to 7 days
  description: time to first feed in hours is used
  measure: The incidence rate of adverse reaction
  time frame: 7 days
  description: adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.
  measure: Satisfaction score with pain management
  time frame: 7 days
  description: measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
  arm group label: whole-process transcutaneous electrical acupoint stimulation
  arm group type: Experimental
  description: Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.
  arm group label: whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
  arm group type: Sham Comparator
  description: Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.
  intervention type: Other
  intervention name: transcutaneous electrical acupoint stimulation
  description: Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.
  arm group label: whole-process transcutaneous electrical acupoint stimulation
  intervention type: Other
  intervention name: transcutaneous electrical acupoint stimulation sham stimulation
  description: Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.
  arm group label: whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guoxin Li, M.D.,Ph.D.
  role: Principal Investigator
  affiliation: Nanfang Hospital, Southern Medical University
  last name: Guoxin Li, M.D.,Ph.D.
  phone: +86 13802771450
  email: gzliguoxin@163.com
  last name: Fang Qin, MS.N.
  phone: +86 15018410013
  email: qf_smu@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor