<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/NCT02987192</url>
  </required_header>
  <id_info>
    <org_study_id>MICS2016033</org_study_id>
    <nct_id>NCT02987192</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section</brief_title>
  <official_title>Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal canal anesthesia is marked the most commonly used method of cesarean section.&#xD;
      Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty&#xD;
      of parturients are undergoing anticoagulation therapy.They may be forced to accept general&#xD;
      anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive&#xD;
      spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditional group patients will receive cutting type 22 gauge needles, while minimally&#xD;
      invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to&#xD;
      the intervention allocations. Spinal anesthesia will be performed with a standardized&#xD;
      technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with&#xD;
      patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the&#xD;
      needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation,&#xD;
      anesthesia plane and measure post-dural puncture headache, post-operative back pain and&#xD;
      epidural hematoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue score of post-dural puncture headache</measure>
    <time_frame>1 to 7 days after operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue score of low back pain</measure>
    <time_frame>1 to 7 days after operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anticoagulation</condition>
  <condition>Minimally Invasive</condition>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>traditional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional group patients will receive cutting type 22 gauge needles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>minimally invasive group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>minimally invasive group patients will receive pen type 27 gauge needles</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pen type 27 gauge needles</intervention_name>
    <description>minimally invasive group patients will receive pen type 27 gauge needles.</description>
    <arm_group_label>minimally invasive group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cutting type 22 gauge needles</intervention_name>
    <description>traditional group patients will receive cutting type 22 gauge needles.</description>
    <arm_group_label>traditional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. puerpera accept anticoagulation therapy&#xD;
&#xD;
          2. American society of anesthesiologists(ASA) classification I to II level&#xD;
&#xD;
          3. Willing to participate in this study and signed an informed consent&#xD;
&#xD;
          4. pregnancy at least 37 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. platelet count less than 50*100000000&#xD;
&#xD;
          2. International Normalized Ratio more than 1.5&#xD;
&#xD;
          3. site of puncture with infection&#xD;
&#xD;
          4. with intracranial hypertension&#xD;
&#xD;
          5. with lumbar spine or spinal cord disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>WEIFENG YU, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DAN HUANG, MS</last_name>
    <phone>15921108822</phone>
    <email>huangdan363@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>JIE ZHOU, MS</last_name>
    <phone>13601693227</phone>
    <email>zhoujie1486@renji.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Renji Hospital, Shanghai Jiao Tong University, School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DAN HUANG, MS</last_name>
      <phone>15921108822</phone>
      <email>huangdan363@163.com</email>
    </contact>
    <contact_backup>
      <last_name>JIE ZHOU, MS</last_name>
      <phone>13601693227</phone>
      <email>zhoujie1486@renji.com</email>
    </contact_backup>
    <investigator>
      <last_name>DAN HUANG, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>July 1, 2017</last_update_submitted>
  <last_update_submitted_qc>July 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>DAN HUANG</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>spinal anesthesia</keyword>
  <keyword>anticoagulation</keyword>
  <keyword>minimally invasive</keyword>
  <keyword>Cesarean Section</keyword>
  <keyword>Maternal</keyword>
  <pending_results>
    <submitted>January 7, 2019</submitted>
    <returned>April 9, 2019</returned>
  </pending_results>
  <!-- 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/NCT02987192
org study id: MICS2016033
nct id: NCT02987192
lead sponsor: 
has dmc: No
Spinal canal anesthesia is marked the most commonly used method of cesarean section.
      Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty
      of parturients are undergoing anticoagulation therapy.They may be forced to accept general
      anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive
      spinal anesthesia.
Traditional group patients will receive cutting type 22 gauge needles, while minimally
      invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to
      the intervention allocations. Spinal anesthesia will be performed with a standardized
      technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with
      patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the
      needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation,
      anesthesia plane and measure post-dural puncture headache, post-operative back pain and
      epidural hematoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Visual analogue score of post-dural puncture headache
time frame: 1 to 7 days after operation
measure: Visual analogue score of low back pain
time frame: 1 to 7 days after operation
arm group label: traditional group
arm group type: Experimental
description: Traditional group patients will receive cutting type 22 gauge needles
arm group label: minimally invasive group
arm group type: Experimental
description: minimally invasive group patients will receive pen type 27 gauge needles
intervention type: Device
intervention name: pen type 27 gauge needles
description: minimally invasive group patients will receive pen type 27 gauge needles.
arm group label: minimally invasive group
intervention type: Device
intervention name: cutting type 22 gauge needles
description: traditional group patients will receive cutting type 22 gauge needles.
arm group label: traditional group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: WEIFENG YU, MD
role: Study Chair
affiliation: Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine
last name: DAN HUANG, MS
phone: 15921108822
email: huangdan363@163.com
last name: JIE ZHOU, MS
phone: 13601693227
email: zhoujie1486@renji.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: DAN HUANG
investigator title: Dr.
submitted: January 7, 2019
returned: April 9, 2019