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/NCT06015165</url>
    </required_header>
    <id_info>
      <org_study_id>ChinaJapanFHAnesth3</org_study_id>
      <nct_id>NCT06015165</nct_id>
    </id_info>
    <brief_title>Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery</brief_title>
    <official_title>Outcomes for Anesthesiologist-Led Care of Analgesic Protocol in Anorectal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China-Japan Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship Hospital</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>
        This will be an open, prospective, parallel-group, randomized controlled trial. Patients&#xD;
        scheduled for complex anorectal surgery under general anesthesia will be enrolled, and the&#xD;
        perioperative analgesia mode led by anesthesiologists will be established. Compared with the&#xD;
        perioperative analgesia mode led by surgeons, the efficacy and safety of analgesia, quality&#xD;
        of life and satisfaction of patients will be evaluated. This study is aimed at the&#xD;
        feasibility and efficiacy of anesthesiologist-led treatment mode in the management of&#xD;
        moderate and severe pain in patients after complex anorectal surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients suffer from moderate to severe postoperative pain up to 14 days after anorectal&#xD;
        surgery. To establish an anesthesiologist-led multidisciplinary team for postoperative&#xD;
        analgesia in anorectal surgery under short and complex general anesthesia. However, the&#xD;
        implementation of perioperative analgesia in anorectal surgery has not been paid enough&#xD;
        attention. This study aims to establish the application of anesthesiologist-led&#xD;
        multidisciplinary postoperative analgesia in anorectal surgery under general anesthesia.&#xD;
  &#xD;
        Objectives: Patients undergoing complex anorectal surgery under general anesthesia will be&#xD;
        randomly divided into two groups: anesthesiologist-led group (Anes Group) and surgeon-led&#xD;
        group (Surg Group).&#xD;
  &#xD;
        Interventions: Both groups will receive general anesthesia combined with long-term local&#xD;
        anesthesia, postoperative patient controlled intravenous analgesia (PCIA) and multi-mode&#xD;
        analgesia including laxatives and antibiotics. In Anes Group, patients receive postoperative&#xD;
        analgesia following the protocol established by the anesthesiologist, continuous with&#xD;
        intraoperative analgesic protocol. In Surg Group, patients will be given postoperative&#xD;
        analgesia and follow-ups by the traditional mode formulated by the surgeons and the&#xD;
        consultant of the pharmacists. The postoperative PCIA analgesic formula and the choice of&#xD;
        analgesics are same in the two groups.&#xD;
  &#xD;
        Follow-ups and outcomes: Patients will be followed-up till 14 days after surgery. Primary&#xD;
        outcome is total opioid use after surgery. Secondary outcomes include the degree of pain&#xD;
        during defecation and rest pain, the adverse reactions related to analgesia, satisfaction,&#xD;
        the time of ambulation, the length of hospital stay and the time of returning to normal life&#xD;
        and work.&#xD;
  &#xD;
        The purpose of this study was to evaluate the feasibility of anesthesiologist-led care model&#xD;
        in complex anorectal surgery and to optimize the perioperative analgesia in anorectal&#xD;
        surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 10, 2023</start_date>
    <completion_date type="Anticipated">October 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</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>Patients undergoing complex anorectal surgery under general anesthesia will be included in this study. In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment. Patients in the Surg. Group will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>This is an open label trial.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>total opioid use after surgery</measure>
      <time_frame>from the end of the surgery till 14 days after surgery</time_frame>
      <description>Total opioid use from postoperative period till the discontinuation of surgery-related therapy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative rest pain</measure>
      <time_frame>followed up once a day till 14 days after surgery</time_frame>
      <description>postoperative rest pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative defecation pain</measure>
      <time_frame>followed up once a day till 14 days after surgery</time_frame>
      <description>postoperative defecation pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adverse reactions</measure>
      <time_frame>followed up once a day till 14 days after surgery</time_frame>
      <description>adverse reactions including postoperative nausea and vomiting(PONV), dizziness, respiratory depression, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patients' satisfaction</measure>
      <time_frame>followed up once a day till 14 days after surgery</time_frame>
      <description>patients' satisfaction self-rating 1-10</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Anes Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will evaluate the patient's pain degree and symptoms perioperatively at bedside, and will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Surg. group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>According to the current perioperative management mode, patients in the surgeon-led group (Surg. group) will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Multi-modal analgesia for Anes. Group</intervention_name>
      <description>For Anes. Group, hydromorphone intravenous pump (PCIA) with 0.04mg/hr and 0.2mg/hr bolus controlled administration. Rescue opioids will be given as sufentanil 5μg/hr, depending on the time of the last intraoperative administration. NSAIDs such as flurbiprofen axetil or ibuprofen will be administered as a complementary treatment option.</description>
      <arm_group_label>Anes Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Multi-modal analgesia for Surg. Group</intervention_name>
      <description>For Surg. Group, hydromorphone intravenous pump is set with the same analgesic formula as in Anes. Group. Routine prescriptions for rescue opioids (tramadol) and NSAIDs according to pain level recommended by the pharmacy department will be administered.</description>
      <arm_group_label>Surg. group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Multi-modal analgesia during the surgery</intervention_name>
      <description>Multi-modal analgesia, including intraoperative long-acting local anesthetics (ropivacaine and methylene blue), perioperative narcotic analgesics, and postoperative laxative and antibiotics. PCIA with the same analgesic formula will be applied in both groups.</description>
      <arm_group_label>Anes Group</arm_group_label>
      <arm_group_label>Surg. group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. American Society of Anesthesia (ASA) grading I-III&#xD;
  &#xD;
            2. ≥18 years old&#xD;
  &#xD;
            3. Patients scheduled for complex anorectal surgery under general anesthesia, e.g., mixed&#xD;
               hemorrhoidectomy/sclerosing agent injection/ligation, radical anal fistula resection,&#xD;
               peri-anal abscess incision and drainage&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Informed consent not obtained&#xD;
  &#xD;
            2. Allergic to general anesthetics, hydromorphone, non-steroidal anti-inflammatory drugs&#xD;
               and other related ingredients&#xD;
  &#xD;
            3. Opioid abuse or pathological pain that requires long-term analgesic treatment&#xD;
  &#xD;
            4. History of severe asthma attack and acute phase of asthma&#xD;
  &#xD;
            5. Moderate or above ventilatory function or diffusion dysfunction&#xD;
  &#xD;
            6. Liver dysfunction reached Child B grade; Renal insufficiency reached chronic kidney&#xD;
               disease (CKD) stage IV&#xD;
  &#xD;
            7. Gastric retention and paralytic ileus&#xD;
  &#xD;
            8. Pregnant and lactating patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wei Xia Li, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>China-Japan Friendship Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Fang WANG, Doctor</last_name>
      <phone>+8615011393879</phone>
      <email>lilythewolf@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Meng Tao ZHENG, Doctor</last_name>
      <phone>+8613811000378</phone>
      <email>dragon0303@sina.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Li Fang Wang</investigator_full_name>
      <investigator_title>attending doctor</investigator_title>
    </responsible_party>
    <keyword>ambulatory surgery</keyword>
    <keyword>anorectal surgery</keyword>
    <keyword>postoperative analgesia</keyword>
    <keyword>anesthesiologist-led care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06015165
  org study id: ChinaJapanFHAnesth3
  nct id: NCT06015165
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This will be an open, prospective, parallel-group, randomized controlled trial. Patients
        scheduled for complex anorectal surgery under general anesthesia will be enrolled, and the
        perioperative analgesia mode led by anesthesiologists will be established. Compared with the
        perioperative analgesia mode led by surgeons, the efficacy and safety of analgesia, quality
        of life and satisfaction of patients will be evaluated. This study is aimed at the
        feasibility and efficiacy of anesthesiologist-led treatment mode in the management of
        moderate and severe pain in patients after complex anorectal surgery.
  Patients suffer from moderate to severe postoperative pain up to 14 days after anorectal
        surgery. To establish an anesthesiologist-led multidisciplinary team for postoperative
        analgesia in anorectal surgery under short and complex general anesthesia. However, the
        implementation of perioperative analgesia in anorectal surgery has not been paid enough
        attention. This study aims to establish the application of anesthesiologist-led
        multidisciplinary postoperative analgesia in anorectal surgery under general anesthesia.
  
        Objectives: Patients undergoing complex anorectal surgery under general anesthesia will be
        randomly divided into two groups: anesthesiologist-led group (Anes Group) and surgeon-led
        group (Surg Group).
  
        Interventions: Both groups will receive general anesthesia combined with long-term local
        anesthesia, postoperative patient controlled intravenous analgesia (PCIA) and multi-mode
        analgesia including laxatives and antibiotics. In Anes Group, patients receive postoperative
        analgesia following the protocol established by the anesthesiologist, continuous with
        intraoperative analgesic protocol. In Surg Group, patients will be given postoperative
        analgesia and follow-ups by the traditional mode formulated by the surgeons and the
        consultant of the pharmacists. The postoperative PCIA analgesic formula and the choice of
        analgesics are same in the two groups.
  
        Follow-ups and outcomes: Patients will be followed-up till 14 days after surgery. Primary
        outcome is total opioid use after surgery. Secondary outcomes include the degree of pain
        during defecation and rest pain, the adverse reactions related to analgesia, satisfaction,
        the time of ambulation, the length of hospital stay and the time of returning to normal life
        and work.
  
        The purpose of this study was to evaluate the feasibility of anesthesiologist-led care model
        in complex anorectal surgery and to optimize the perioperative analgesia in anorectal
        surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients undergoing complex anorectal surgery under general anesthesia will be included in this study. In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment. Patients in the Surg. Group will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: This is an open label trial.
  measure: total opioid use after surgery
  time frame: from the end of the surgery till 14 days after surgery
  description: Total opioid use from postoperative period till the discontinuation of surgery-related therapy.
  measure: postoperative rest pain
  time frame: followed up once a day till 14 days after surgery
  description: postoperative rest pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain
  measure: postoperative defecation pain
  time frame: followed up once a day till 14 days after surgery
  description: postoperative defecation pain in Numeric Rating Scales (NRS) 1-10, when 0 means painless, and 10 means the highest level of unbearable pain
  measure: adverse reactions
  time frame: followed up once a day till 14 days after surgery
  description: adverse reactions including postoperative nausea and vomiting(PONV), dizziness, respiratory depression, etc.
  measure: patients' satisfaction
  time frame: followed up once a day till 14 days after surgery
  description: patients' satisfaction self-rating 1-10
  arm group label: Anes Group
  arm group type: Experimental
  description: In Anes Group, the anesthesiologist routinely works in the operating room, and will communicate with anorectal physicians through bedside visits, video telephone calls, and a hospital-wide electronic medical record system in the operating room. Anesthesiologists will evaluate the patient's pain degree and symptoms perioperatively at bedside, and will administer opioids or non-opioids at the optimal interval and standard dose until discharge. The anesthesiologist and the surgeon will jointly formulate the discharge medication plan and give the patient guidance on analgesic treatment.
  arm group label: Surg. group
  arm group type: Active Comparator
  description: According to the current perioperative management mode, patients in the surgeon-led group (Surg. group) will be given local anesthesia during the operation, and will receive routine ambulatory surgery anesthesia plan, and routine postoperative analgesia plan in the ward will be given to the patients, under the guidance of the department of pharmacy. The patients will receive rescue opioids and standardized NSAIDs until discharge.
  intervention type: Drug
  intervention name: Multi-modal analgesia for Anes. Group
  description: For Anes. Group, hydromorphone intravenous pump (PCIA) with 0.04mg/hr and 0.2mg/hr bolus controlled administration. Rescue opioids will be given as sufentanil 5μg/hr, depending on the time of the last intraoperative administration. NSAIDs such as flurbiprofen axetil or ibuprofen will be administered as a complementary treatment option.
  arm group label: Anes Group
  intervention type: Drug
  intervention name: Multi-modal analgesia for Surg. Group
  description: For Surg. Group, hydromorphone intravenous pump is set with the same analgesic formula as in Anes. Group. Routine prescriptions for rescue opioids (tramadol) and NSAIDs according to pain level recommended by the pharmacy department will be administered.
  arm group label: Surg. group
  intervention type: Procedure
  intervention name: Multi-modal analgesia during the surgery
  description: Multi-modal analgesia, including intraoperative long-acting local anesthetics (ropivacaine and methylene blue), perioperative narcotic analgesics, and postoperative laxative and antibiotics. PCIA with the same analgesic formula will be applied in both groups.
  arm group label: Anes Group
  arm group label: Surg. group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Wei Xia Li, Doctor
  role: Study Director
  affiliation: China-Japan Friendship Hospital
  last name: Li Fang WANG, Doctor
  phone: +8615011393879
  email: lilythewolf@sina.com
  last name: Meng Tao ZHENG, Doctor
  phone: +8613811000378
  email: dragon0303@sina.com
  responsible party type: Principal Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Li Fang Wang
  investigator title: attending doctor
  mesh term: Pain, Postoperative
  sharing ipd: No