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/NCT05984212</url>
    </required_header>
    <id_info>
      <org_study_id>4-2023-0611</org_study_id>
      <nct_id>NCT05984212</nct_id>
    </id_info>
    <brief_title>Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery</brief_title>
    <official_title>Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yonsei University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yonsei 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>
        In this study, the investigators aimed to demonstrate if the quality of recovery in patients&#xD;
        undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block&#xD;
        and intraoperative opioid administration based on analgesia nociception index, improves&#xD;
        compared to the patients without block.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Double blind randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Recovery 40 scale score at postoperative 24 hour</measure>
      <time_frame>24 hours after the end of surgery</time_frame>
      <description>Postoperative quality of recovery according to the block performance</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intraoperative remifentanil consumption,postoperative pain score</measure>
      <time_frame>at 0, 1, 6, 12, and 24 hours postoperative</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rescue analgesics administered up to 24 hours postoperatively</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>satisfaction with pain control</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>Patient self-rated overall satisfaction with pain control. Evaluated on an 11-point scale from 0 to 10, with 0 points for completely dissatisfied and 10 points for complete satisfaction. The higher the number, the more satisfactory it is.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>serum cortisol level (μg/dL) before and after surgery</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>leukocyte level (10^3/μL) before and after surgery</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>arterial pH before and after surgery</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood glucose level (mg/dL) before and after surgery</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>measurement of adequate analgesia (NRS &lt;4) before and after surgery</measure>
      <time_frame>intraoprative and postoperative 24hours</time_frame>
      <description>To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Single Port Laparoscopic Adnexal Surgery</condition>
    <arm_group>
      <arm_group_label>dexmedetomidine infusion group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>normal saline infusion group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ultrasound guided rectus sheath block with dexmedetomidine</intervention_name>
      <description>Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)</description>
      <arm_group_label>dexmedetomidine infusion group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ultrasound guided rectus sheath block with normal saline</intervention_name>
      <description>Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)</description>
      <arm_group_label>normal saline infusion group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic&#xD;
          adnexal surgery under general anesthesia at Yonsei Cancer Center&#xD;
  &#xD;
          1. patients with moderate to severe pain before surgery 2. patients with history of taking&#xD;
          chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local&#xD;
          anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns&#xD;
          who cannot communicate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Youngwon Kim</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Youngwon Kim</last_name>
      <phone>82-10-4240-6849</phone>
      <email>youngwon@yuhs.ac</email>
    </overall_contact>
    <location>
      <facility>
        <name>Severance hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Youngwon Kim</last_name>
        <phone>82-10-4240-6849</phone>
        <email>youngwon@yuhs.ac</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05984212
  org study id: 4-2023-0611
  nct id: NCT05984212
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the investigators aimed to demonstrate if the quality of recovery in patients
        undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block
        and intraoperative opioid administration based on analgesia nociception index, improves
        compared to the patients without block.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Double blind randomized controlled trial
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
  measure: Quality of Recovery 40 scale score at postoperative 24 hour
  time frame: 24 hours after the end of surgery
  description: Postoperative quality of recovery according to the block performance
  measure: Intraoperative remifentanil consumption,postoperative pain score
  time frame: at 0, 1, 6, 12, and 24 hours postoperative
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: rescue analgesics administered up to 24 hours postoperatively
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: satisfaction with pain control
  time frame: intraoprative and postoperative 24hours
  description: Patient self-rated overall satisfaction with pain control. Evaluated on an 11-point scale from 0 to 10, with 0 points for completely dissatisfied and 10 points for complete satisfaction. The higher the number, the more satisfactory it is.
  measure: serum cortisol level (μg/dL) before and after surgery
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: leukocyte level (10^3/μL) before and after surgery
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: arterial pH before and after surgery
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: blood glucose level (mg/dL) before and after surgery
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  measure: measurement of adequate analgesia (NRS <4) before and after surgery
  time frame: intraoprative and postoperative 24hours
  description: To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
  arm group label: dexmedetomidine infusion group
  arm group type: Experimental
  arm group label: normal saline infusion group
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Ultrasound guided rectus sheath block with dexmedetomidine
  description: Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)
  arm group label: dexmedetomidine infusion group
  intervention type: Drug
  intervention name: Ultrasound guided rectus sheath block with normal saline
  description: Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)
  arm group label: normal saline infusion group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Youngwon Kim
  role: Principal Investigator
  affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
  last name: Youngwon Kim
  phone: 82-10-4240-6849
  email: youngwon@yuhs.ac
  facility: 
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Dexmedetomidine