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/NCT06019039</url>
    </required_header>
    <id_info>
      <org_study_id>m649</org_study_id>
      <nct_id>NCT06019039</nct_id>
    </id_info>
    <brief_title>Power Doppler Ultrasonography in Localization of Epidural Catheter</brief_title>
    <official_title>The Role of Power Doppler Ultrasonography in Localization of Epidural Catheter : an Observational Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yasser S Mostafa, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fayoum University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fayoum University Hospital</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>
        Epidural anesthesia is a widely used method for pain relief which is useful in various&#xD;
        settings. Identification of needle entry into the epidural space (EDS) is performed most&#xD;
        using a loss of resistance (LOR) technique, which was described in 1921 by Sicard and&#xD;
        Forestier, and has remained largely unchanged since. Hysterectomy operations anesthesia and&#xD;
        analgesia rely heavily on proper needle placement technique. A noninvasive approach to&#xD;
        confirm the correct position of the epidural needle prior to injection of local anesthetics&#xD;
        into the epidural space, would thus be beneficial. Ultrasound (US) is a noninvasive approach&#xD;
        increasingly used in anesthesia practice. The use of color flow Doppler (CFD) may further aid&#xD;
        in defining the epidural space. The aim of current study is to detect and confirm site of&#xD;
        epidural catheter in hysterectomy by using color flow doppler ultrasonography.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be performed in the Fayoum University hospital. The study design will be&#xD;
        prospective study. A detailed informed consent will be signed by the eligible patients .&#xD;
  &#xD;
        female patients who undergoing an ultrasound guided for hysterectomy will be included in this&#xD;
        review. The ultrasound guided epidural will be used in those in which an anticipated&#xD;
        technical difficult landmark epidural space localization will be expected. These included&#xD;
        those patients with diagnosis of obesity, defined as Body Mass Index (BMI) ≥35 kg/m2, and&#xD;
        lumbar scoliosis, as well as those with poorly defined surface lumbar bone anatomy.&#xD;
  &#xD;
        Demographic data, intervertebral level of insertion, dermatome level, and failure rate of&#xD;
        epidural needle placement using CFD will be noted for each patient. Operation will be&#xD;
        obtained via spinal epidural technique.&#xD;
  &#xD;
        Sterile preparation and dropping of the area will be followed by placement of a curvilinear&#xD;
        ultrasound transducer in a sterile sheath. The ultrasound will be used to identify the&#xD;
        interspinous space. The epidural needle will be guided with the use of ultrasound direction&#xD;
        by the use of an out of plane technique.&#xD;
  &#xD;
        A two-hand technique will be used to manipulate the needle and ultrasound probe.&#xD;
  &#xD;
        A 17-G Tuohy needle (Braun Medical, Inc., Melsungen,AG, Germany) will be advanced until loss&#xD;
        of resistance to normal saline will be attained.&#xD;
  &#xD;
        Confirmation of the epidural space with the use of CFD will be then obtained after injection&#xD;
        of up to 10 mL of normal saline through the epidural needle.&#xD;
  &#xD;
        A 21-G epidural catheter (B. Braun Medical, Inc.) will be then threaded into the epidural&#xD;
        space.&#xD;
  &#xD;
        A 22G, 50mm needle (SONOTAP,Pajunk,Geisingen,Germany will be then advanced until CSF is&#xD;
        obtained.&#xD;
  &#xD;
        Use of intrathecal local anesthetic will be then used as a bolus in the spinal space.&#xD;
  &#xD;
        After loss of resistance to normal saline, the CFD function will be turned on to examine flow&#xD;
        through the epidural needle tip.&#xD;
  &#xD;
        The ultrasound probe was positioned in the transverse axis slightly below the epidural needle&#xD;
        but still in the interspinous space .&#xD;
  &#xD;
        Two-dimensional (2D) ultrasound images will be initially obtained after making adjustments on&#xD;
        the ultrasound system.&#xD;
  &#xD;
        These include an appropriate scanning depth (6-12 cm), using the &quot;penetration&quot; or &quot;general&quot;&#xD;
        frequency range and adjusting the gain or the time gate compensation to improve image&#xD;
        resolution.&#xD;
  &#xD;
        The CFD function will be then turned on and then the window will be adjusted to be centered&#xD;
        over the area of interest. The authors will adjust color baseline to enhance the qualitative&#xD;
        depiction of flow. The authors also increased color gain to amplify the appearance of flow&#xD;
        changes. The color gain was adjusted to a level that provided the best image while avoiding&#xD;
        the display of random color speckles. The orientation and tilt of the ultrasound probe will&#xD;
        be essential for optimal visualization of the CFD pattern.&#xD;
  &#xD;
        The best views were obtained while the probe was tilted upwards, parallel to the lumbar&#xD;
        spinous process orientation, in order to avoid shadow interference cast by the spinous&#xD;
        process bony structure. This maneuver will optimize the 2D view by minimizing the shadowing&#xD;
        caused by bony structures.&#xD;
  &#xD;
        The color scale will be adjusted to maximize color flow while avoiding excessive aliasing.&#xD;
  &#xD;
        The best images will be best seen with a color scale on the range of 12-20 without needing to&#xD;
        adjust the baseline.&#xD;
  &#xD;
        Sample size was calculated using G-Power©️ software version 3.1.7 (Institute of experimental&#xD;
        psychology, Heinrich Heine University, Dusseldorf, Germany).Minimal sample size of patients&#xD;
        was (60) patients. Effect size 0.47 Depending on previous research results. Two tailed type I&#xD;
        error 0.05 and power of 80%.&#xD;
  &#xD;
        Statistical analysis will be performed using SPSS version 24.0 (IBM, Armonk, NY, USA). Data&#xD;
        will be tested for normality using the Kolmogorov-Smirnov test. Continuous variables are&#xD;
        presented as mean ± standard deviation (SD) or median (interquartile range) as appropriate&#xD;
        and categorical variables are presented as number of patients (%). Parametric continuous&#xD;
        variables will be analyzed by unpaired t-test and non-parametric continuous variables will be&#xD;
        analyzed by Mann-Whitney U test. For categorical variables, the Chi-square (X2) test or&#xD;
        Fisher's exact test will be used as appropriate. Two-tailed p values of 0.05 will be&#xD;
        considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Visualization of flow relative to the interspace insertion level by color flow Doppler</measure>
      <time_frame>1 minute after insertion of epidural catheter</time_frame>
      <description>Yes or no</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Level of epidural catheter insertion</measure>
      <time_frame>1 minute after insertion of epidural catheter</time_frame>
      <description>From Lumbar level 1 to 5</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Verbal numerical rating scale</measure>
      <time_frame>8 hours postoperatively</time_frame>
      <description>0-10 where 0: no pain and 10:worst pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of epidural analgesia</measure>
      <time_frame>First 24 hours postoperatively.</time_frame>
      <description>in hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of patchy or asymmetric block</measure>
      <time_frame>15 minutes after insertion of epidural catheter</time_frame>
      <description>Yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum upper sensory block to ice as charted by the nurse</measure>
      <time_frame>15 minutes after insertion of epidural catheter</time_frame>
      <description>Dermatomal level thoracic level 10 up to umbilicus</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervertebral level at which the epidural catheter is inserted</measure>
      <time_frame>1 minute after insertion of epidural catheter</time_frame>
      <description>From Lumbar level 2-3 or 3-4</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Age</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>in years</description>
    </other_outcome>
    <other_outcome>
      <measure>Height</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>in meter</description>
    </other_outcome>
    <other_outcome>
      <measure>Weight</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>in kilogram</description>
    </other_outcome>
    <other_outcome>
      <measure>Body mass index</measure>
      <time_frame>1 hour preoperatively</time_frame>
      <description>kilogram/square meter</description>
    </other_outcome>
    <other_outcome>
      <measure>Duration of surgery</measure>
      <time_frame>Up to 5 hours</time_frame>
      <description>in hours</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Uterine Diseases</condition>
    <arm_group>
      <arm_group_label>Epidural Ultrasound group</arm_group_label>
      <description>After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Normal Saline Flush</intervention_name>
      <description>Five milliliters of sterile saline will be administered as a flush through the needle while recording the color flow doppler images. The same procedure will be repeated with a slow injection of 5 mL of saline. The speed of injection will not be standardized.</description>
      <arm_group_label>Epidural Ultrasound group</arm_group_label>
      <other_name>0.9% isotonic normal saline</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Doppler</intervention_name>
      <description>All color flow Doppler images will be performed with a Phillips CX50 ultrasound machine using a 5.0 MHz a low frequency curvilinear US probe. A two-dimensional transverse interspinous view was used to visualize the posterior complex (ligamentum flavum, epidural space and dura). After loss of resistance to normal saline, the color flow Doppler function will be turned on to examine flow through the epidural needle tip.&#xD;
  The ultrasound probe was positioned in the transverse axis slightly below the epidural needle but still in the interspinous space .</description>
      <arm_group_label>Epidural Ultrasound group</arm_group_label>
      <other_name>Color flow Doppler</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Primary gynecology and obstetric care clinic in Fayoum university hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who will have hysterectomy operation under epidural analgesia&#xD;
  &#xD;
            -  Women with the epidural catheter still in place&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status I, II&#xD;
  &#xD;
            -  Age range from 30 and 70 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  History of allergy to one of the study drugs.&#xD;
  &#xD;
            -  Any contraindication to regional anesthesia such as local infection or bleeding&#xD;
               disorders&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Atef M Sayed, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fayoum University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Abeer S Goda, MD</last_name>
      <role>Study Director</role>
      <affiliation>Fayoum University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Taha M Agamy, M.B.B.CH</last_name>
      <phone>01015909635</phone>
      <phone_ext>+2</phone_ext>
      <email>tma11@fauom.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joseph M Botros, MD</last_name>
      <phone>01227598825</phone>
      <phone_ext>+2</phone_ext>
      <email>jmb00@fayoum.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fayoum University Hospital</name>
        <address>
          <city>Fayoum</city>
          <state>Faiyum</state>
          <zip>63514</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yasser S Mostafa, MD.</last_name>
        <phone>01010509735</phone>
        <phone_ext>+20</phone_ext>
        <email>ysm03@fayoum.edu.eg</email>
      </contact>
      <investigator>
        <last_name>Joseph M Botros, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Atef M Sayed, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Taha M Agamy, MBBCh</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Abeer S Goda, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Liu Y, He S, Zhou S. Effect of general anesthesia combined with epidural anesthesia on circulation and stress response of patients undergoing hysterectomy. Am J Transl Res. 2021 May 15;13(5):5294-5300. eCollection 2021.</citation>
      <PMID>34150121</PMID>
    </reference>
    <reference>
      <citation>Elsharkawy H, Sonny A, Chin KJ. Localization of epidural space: A review of available technologies. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):16-27. doi: 10.4103/0970-9185.202184.</citation>
      <PMID>28413269</PMID>
    </reference>
    <reference>
      <citation>Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.</citation>
      <PMID>30482003</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University Hospital</investigator_affiliation>
      <investigator_full_name>Yasser S Mostafa, MD</investigator_full_name>
      <investigator_title>Lecturer of anesthesia</investigator_title>
    </responsible_party>
    <keyword>Power doppler ultrasonography</keyword>
    <keyword>Epidural catheter</keyword>
    <keyword>Hysterectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Diseases</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/NCT06019039
  org study id: m649
  nct id: NCT06019039
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Epidural anesthesia is a widely used method for pain relief which is useful in various
        settings. Identification of needle entry into the epidural space (EDS) is performed most
        using a loss of resistance (LOR) technique, which was described in 1921 by Sicard and
        Forestier, and has remained largely unchanged since. Hysterectomy operations anesthesia and
        analgesia rely heavily on proper needle placement technique. A noninvasive approach to
        confirm the correct position of the epidural needle prior to injection of local anesthetics
        into the epidural space, would thus be beneficial. Ultrasound (US) is a noninvasive approach
        increasingly used in anesthesia practice. The use of color flow Doppler (CFD) may further aid
        in defining the epidural space. The aim of current study is to detect and confirm site of
        epidural catheter in hysterectomy by using color flow doppler ultrasonography.
  This study will be performed in the Fayoum University hospital. The study design will be
        prospective study. A detailed informed consent will be signed by the eligible patients .
  
        female patients who undergoing an ultrasound guided for hysterectomy will be included in this
        review. The ultrasound guided epidural will be used in those in which an anticipated
        technical difficult landmark epidural space localization will be expected. These included
        those patients with diagnosis of obesity, defined as Body Mass Index (BMI) ≥35 kg/m2, and
        lumbar scoliosis, as well as those with poorly defined surface lumbar bone anatomy.
  
        Demographic data, intervertebral level of insertion, dermatome level, and failure rate of
        epidural needle placement using CFD will be noted for each patient. Operation will be
        obtained via spinal epidural technique.
  
        Sterile preparation and dropping of the area will be followed by placement of a curvilinear
        ultrasound transducer in a sterile sheath. The ultrasound will be used to identify the
        interspinous space. The epidural needle will be guided with the use of ultrasound direction
        by the use of an out of plane technique.
  
        A two-hand technique will be used to manipulate the needle and ultrasound probe.
  
        A 17-G Tuohy needle (Braun Medical, Inc., Melsungen,AG, Germany) will be advanced until loss
        of resistance to normal saline will be attained.
  
        Confirmation of the epidural space with the use of CFD will be then obtained after injection
        of up to 10 mL of normal saline through the epidural needle.
  
        A 21-G epidural catheter (B. Braun Medical, Inc.) will be then threaded into the epidural
        space.
  
        A 22G, 50mm needle (SONOTAP,Pajunk,Geisingen,Germany will be then advanced until CSF is
        obtained.
  
        Use of intrathecal local anesthetic will be then used as a bolus in the spinal space.
  
        After loss of resistance to normal saline, the CFD function will be turned on to examine flow
        through the epidural needle tip.
  
        The ultrasound probe was positioned in the transverse axis slightly below the epidural needle
        but still in the interspinous space .
  
        Two-dimensional (2D) ultrasound images will be initially obtained after making adjustments on
        the ultrasound system.
  
        These include an appropriate scanning depth (6-12 cm), using the "penetration" or "general"
        frequency range and adjusting the gain or the time gate compensation to improve image
        resolution.
  
        The CFD function will be then turned on and then the window will be adjusted to be centered
        over the area of interest. The authors will adjust color baseline to enhance the qualitative
        depiction of flow. The authors also increased color gain to amplify the appearance of flow
        changes. The color gain was adjusted to a level that provided the best image while avoiding
        the display of random color speckles. The orientation and tilt of the ultrasound probe will
        be essential for optimal visualization of the CFD pattern.
  
        The best views were obtained while the probe was tilted upwards, parallel to the lumbar
        spinous process orientation, in order to avoid shadow interference cast by the spinous
        process bony structure. This maneuver will optimize the 2D view by minimizing the shadowing
        caused by bony structures.
  
        The color scale will be adjusted to maximize color flow while avoiding excessive aliasing.
  
        The best images will be best seen with a color scale on the range of 12-20 without needing to
        adjust the baseline.
  
        Sample size was calculated using G-Power©️ software version 3.1.7 (Institute of experimental
        psychology, Heinrich Heine University, Dusseldorf, Germany).Minimal sample size of patients
        was (60) patients. Effect size 0.47 Depending on previous research results. Two tailed type I
        error 0.05 and power of 80%.
  
        Statistical analysis will be performed using SPSS version 24.0 (IBM, Armonk, NY, USA). Data
        will be tested for normality using the Kolmogorov-Smirnov test. Continuous variables are
        presented as mean ± standard deviation (SD) or median (interquartile range) as appropriate
        and categorical variables are presented as number of patients (%). Parametric continuous
        variables will be analyzed by unpaired t-test and non-parametric continuous variables will be
        analyzed by Mann-Whitney U test. For categorical variables, the Chi-square (X2) test or
        Fisher's exact test will be used as appropriate. Two-tailed p values of 0.05 will be
        considered statistically significant.
  observational model: Other
  time perspective: Prospective
  measure: Visualization of flow relative to the interspace insertion level by color flow Doppler
  time frame: 1 minute after insertion of epidural catheter
  description: Yes or no
  measure: Level of epidural catheter insertion
  time frame: 1 minute after insertion of epidural catheter
  description: From Lumbar level 1 to 5
  measure: Verbal numerical rating scale
  time frame: 8 hours postoperatively
  description: 0-10 where 0: no pain and 10:worst pain
  measure: Duration of epidural analgesia
  time frame: First 24 hours postoperatively.
  description: in hours
  measure: Incidence of patchy or asymmetric block
  time frame: 15 minutes after insertion of epidural catheter
  description: Yes or no
  measure: Maximum upper sensory block to ice as charted by the nurse
  time frame: 15 minutes after insertion of epidural catheter
  description: Dermatomal level thoracic level 10 up to umbilicus
  measure: Intervertebral level at which the epidural catheter is inserted
  time frame: 1 minute after insertion of epidural catheter
  description: From Lumbar level 2-3 or 3-4
  measure: Age
  time frame: 1 hour preoperatively
  description: in years
  measure: Height
  time frame: 1 hour preoperatively
  description: in meter
  measure: Weight
  time frame: 1 hour preoperatively
  description: in kilogram
  measure: Body mass index
  time frame: 1 hour preoperatively
  description: kilogram/square meter
  measure: Duration of surgery
  time frame: Up to 5 hours
  description: in hours
  arm group label: Epidural Ultrasound group
  description: After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter.
  intervention type: Drug
  intervention name: Normal Saline Flush
  description: Five milliliters of sterile saline will be administered as a flush through the needle while recording the color flow doppler images. The same procedure will be repeated with a slow injection of 5 mL of saline. The speed of injection will not be standardized.
  arm group label: Epidural Ultrasound group
  other name: 0.9% isotonic normal saline
  intervention type: Device
  intervention name: Doppler
  description: All color flow Doppler images will be performed with a Phillips CX50 ultrasound machine using a 5.0 MHz a low frequency curvilinear US probe. A two-dimensional transverse interspinous view was used to visualize the posterior complex (ligamentum flavum, epidural space and dura). After loss of resistance to normal saline, the color flow Doppler function will be turned on to examine flow through the epidural needle tip.
  The ultrasound probe was positioned in the transverse axis slightly below the epidural needle but still in the interspinous space .
  arm group label: Epidural Ultrasound group
  other name: Color flow Doppler
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Atef M Sayed, MD
  role: Principal Investigator
  affiliation: Fayoum University
  last name: Abeer S Goda, MD
  role: Study Director
  affiliation: Fayoum University
  last name: Taha M Agamy, M.B.B.CH
  phone: 01015909635
  phone ext: +2
  email: tma11@fauom.edu.eg
  last name: Joseph M Botros, MD
  phone: 01227598825
  phone ext: +2
  email: jmb00@fayoum.edu.eg
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  citation: Liu Y, He S, Zhou S. Effect of general anesthesia combined with epidural anesthesia on circulation and stress response of patients undergoing hysterectomy. Am J Transl Res. 2021 May 15;13(5):5294-5300. eCollection 2021.
  PMID: 34150121
  citation: Elsharkawy H, Sonny A, Chin KJ. Localization of epidural space: A review of available technologies. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):16-27. doi: 10.4103/0970-9185.202184.
  PMID: 28413269
  citation: Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.
  PMID: 30482003
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fayoum University Hospital
  investigator full name: Yasser S Mostafa, MD
  investigator title: Lecturer of anesthesia
  mesh term: Uterine Diseases
  sharing ipd: No