<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/NCT03750877</url>
  </required_header>
  <id_info>
    <org_study_id>+90</org_study_id>
    <nct_id>NCT03750877</nct_id>
  </id_info>
  <brief_title>Median and Paramedian Approach in Spinal Anesthesia</brief_title>
  <official_title>Evaluation of Median and Paramedian Approach in Spinal Anesthesia in Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trabzon Kanuni Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Trabzon Kanuni Education and Research Hospital</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>
      Spinal anesthesia (SA) is frequently used as anesthesia in many surgeries such as lower&#xD;
      abdominal, inguinal, urogenital, rectal and lower extremities.&#xD;
&#xD;
      Conventional median approach (MA) is preferred more frequently, although MA or paramedian&#xD;
      approach (PA) is used in SA. Especially in geriatric patients due to degenerative changes&#xD;
      Although we are told that degenerative changes are less affected in PA during SA in the&#xD;
      geriatric age group, few studies have been conducted on the subject and we aimed to evaluate&#xD;
      the superiority of the two methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our study, 100 cases were planned to be evaluated prospectively. Patients scheduled for&#xD;
      surgery under spinal anesthesia will undergo routine spinal preparation. After routine&#xD;
      motorization, patients will be treated with MA or PA.&#xD;
&#xD;
      MA will be performed in a conventional manner and PA will be performed by adding 1 cm lateral&#xD;
      and 1 cm caudal from the planned vertebral space to 10-15 degree medial and cephal.&#xD;
&#xD;
      If one of the patients with MA or PA fails, despite three attempts, the other method will be&#xD;
      tried by another specialist. If the procedure fails or there are not enough blocks, a&#xD;
      different anesthesia method will be applied.&#xD;
&#xD;
      The data of the patients included in the study were evaluated by a different researcher other&#xD;
      than the SA physician; demographic data of the cases, type of operation, MA or PA in SA and&#xD;
      the number of repeated attempts / trials for the procedure will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2018</start_date>
  <completion_date type="Actual">February 22, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2019</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>The aim of this study was to evaluate the success rate of median and paramedian approach in spinal anesthesia in geriatric patients, number of trials, number of attempts at another interval due to failure, duration of procedure, patient comfort, change to other method in case of failure and success rate. In the study, two groups were formed: the median approach and the paramedian approach.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>the number of files from the volunteer participants were grouped into one group and the ones with double file numbers were included in the other group.&#xD;
participants do not know which group of patients to be in. Only practitioners know about the procedure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>spinal needle touches the spinal bone</measure>
    <time_frame>during the procedure of spinal anesthesia</time_frame>
    <description>The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of repeated attempts (attempts):</measure>
    <time_frame>during the procedure of spinal anesthesia</time_frame>
    <description>The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>duration of procedure</measure>
    <time_frame>during the procedure of spinal anesthesia</time_frame>
    <description>In spinal anesthesia, the time to reach the skin and the spinal area will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>success rate of spinal needle insertion</measure>
    <time_frame>during the procedure of spinal anesthesia</time_frame>
    <description>The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of the procedure</measure>
    <time_frame>during the procedure of spinal anesthesia and 1 week after spinal anesthesia</time_frame>
    <description>complications of spinal anesthesia will be evaluated, during spinal anesthesia and during the first week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Geriatric Patients</condition>
  <condition>Efficacy, Self</condition>
  <arm_group>
    <arm_group_label>median approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal anesthesia will be performed with a conventional median approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paramedian approach</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal anesthesia will be applied with a paramedian approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>median approach</intervention_name>
    <description>spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.</description>
    <arm_group_label>median approach</arm_group_label>
    <arm_group_label>paramedian approach</arm_group_label>
    <other_name>classical approach</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paramedian approach</intervention_name>
    <description>In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.</description>
    <arm_group_label>median approach</arm_group_label>
    <arm_group_label>paramedian approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 70 years&#xD;
&#xD;
          -  elective surgery under spinal anesthesia&#xD;
&#xD;
          -  those who agreed to participate in the study&#xD;
&#xD;
          -  Those with American Society of Anesthesiologists (ASA) 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who use opioid or other non-steroidal anti-inflammatory drugs regularly&#xD;
&#xD;
          -  who are allergic to a drug used in the study&#xD;
&#xD;
          -  had contraindications for spinal anesthesia,&#xD;
&#xD;
          -  drug addiction&#xD;
&#xD;
          -  obese patients (Body Mass Index ≥ 35)&#xD;
&#xD;
          -  migraine and chronic headache&#xD;
&#xD;
          -  Spinal anesthesia can not be performed in more than 3 trials, but passed to the&#xD;
             general anesthesia&#xD;
&#xD;
          -  those who do not agree to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hülya Kılıç Yılmaz</last_name>
    <role>Study Chair</role>
    <affiliation>Trabzon Kanuni Eğitim araştırma Hastanesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TRABZON</name>
      <address>
        <city>Yomra</city>
        <zip>61500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/28891544</url>
    <description>'Comparison of Epidrum, Epi-jet, and Loss of Resistance Syringe Techniques for Identifying the Epidural Space in Obstetric Patients'</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/15808095</url>
    <description>'Paramedian technique of spinal anesthesia in elderly patients for hip fracture surgery'.</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Trabzon Kanuni Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Seyfi KARTAL, MD</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>median approach</keyword>
  <keyword>paramedian approach</keyword>
  <keyword>geriatric patient</keyword>
  <keyword>spinal anesthesia</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>stated that the personal data will not be shared in the participant consent form in the study design.</ipd_description>
  </patient_data>
  <!-- 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/NCT03750877
org study id: +90
nct id: NCT03750877
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spinal anesthesia (SA) is frequently used as anesthesia in many surgeries such as lower
      abdominal, inguinal, urogenital, rectal and lower extremities.

      Conventional median approach (MA) is preferred more frequently, although MA or paramedian
      approach (PA) is used in SA. Especially in geriatric patients due to degenerative changes
      Although we are told that degenerative changes are less affected in PA during SA in the
      geriatric age group, few studies have been conducted on the subject and we aimed to evaluate
      the superiority of the two methods.
In our study, 100 cases were planned to be evaluated prospectively. Patients scheduled for
      surgery under spinal anesthesia will undergo routine spinal preparation. After routine
      motorization, patients will be treated with MA or PA.

      MA will be performed in a conventional manner and PA will be performed by adding 1 cm lateral
      and 1 cm caudal from the planned vertebral space to 10-15 degree medial and cephal.

      If one of the patients with MA or PA fails, despite three attempts, the other method will be
      tried by another specialist. If the procedure fails or there are not enough blocks, a
      different anesthesia method will be applied.

      The data of the patients included in the study were evaluated by a different researcher other
      than the SA physician; demographic data of the cases, type of operation, MA or PA in SA and
      the number of repeated attempts / trials for the procedure will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The aim of this study was to evaluate the success rate of median and paramedian approach in spinal anesthesia in geriatric patients, number of trials, number of attempts at another interval due to failure, duration of procedure, patient comfort, change to other method in case of failure and success rate. In the study, two groups were formed: the median approach and the paramedian approach.
primary purpose: Other
masking: Single (Participant)
masking description: the number of files from the volunteer participants were grouped into one group and the ones with double file numbers were included in the other group.
participants do not know which group of patients to be in. Only practitioners know about the procedure.
measure: spinal needle touches the spinal bone
time frame: during the procedure of spinal anesthesia
description: The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
measure: Number of repeated attempts (attempts):
time frame: during the procedure of spinal anesthesia
description: The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
measure: duration of procedure
time frame: during the procedure of spinal anesthesia
description: In spinal anesthesia, the time to reach the skin and the spinal area will be evaluated.
measure: success rate of spinal needle insertion
time frame: during the procedure of spinal anesthesia
description: The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.
measure: Complications of the procedure
time frame: during the procedure of spinal anesthesia and 1 week after spinal anesthesia
description: complications of spinal anesthesia will be evaluated, during spinal anesthesia and during the first week
arm group label: median approach
arm group type: Active Comparator
description: Spinal anesthesia will be performed with a conventional median approach
arm group label: paramedian approach
arm group type: Active Comparator
description: Spinal anesthesia will be applied with a paramedian approach.
intervention type: Procedure
intervention name: median approach
description: spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.
arm group label: median approach
arm group label: paramedian approach
other name: classical approach
intervention type: Procedure
intervention name: paramedian approach
description: In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.
arm group label: median approach
arm group label: paramedian approach
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Hülya Kılıç Yılmaz
role: Study Chair
affiliation: Trabzon Kanuni Eğitim araştırma Hastanesi
facility: 
country: Turkey
url: http://www.ncbi.nlm.nih.gov/pubmed/28891544
description: 'Comparison of Epidrum, Epi-jet, and Loss of Resistance Syringe Techniques for Identifying the Epidural Space in Obstetric Patients'
url: http://www.ncbi.nlm.nih.gov/pubmed/15808095
description: 'Paramedian technique of spinal anesthesia in elderly patients for hip fracture surgery'.
responsible party type: Principal Investigator
investigator affiliation: Trabzon Kanuni Education and Research Hospital
investigator full name: Seyfi KARTAL, MD
investigator title: Assistant professor
sharing ipd: No
ipd description: stated that the personal data will not be shared in the participant consent form in the study design.