<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/NCT04431388</url>
  </required_header>
  <id_info>
    <org_study_id>CASVE-NM-20-434</org_study_id>
    <secondary_id>2020-000779-19</secondary_id>
    <nct_id>NCT04431388</nct_id>
  </id_info>
  <brief_title>Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study</brief_title>
  <official_title>Analgesic Effectiveness of the Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Medina del Campo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Medina del Campo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain,&#xD;
      but there are still some patients who describe a severe pain after this surgery. Regional&#xD;
      techniques allow a better recovery quality and adequate- managed pain control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adequate control of pain in patients with nephrectomy is a challenge for the anesthesiologist&#xD;
      who must achieve an early recovery with minimal adverse effects. Within a multimodal&#xD;
      strategy, the work hypothesis is based on comparing the analgesic efficacy of two regional&#xD;
      techniques in patients undergoing nephrectomy, in terms of quality of postoperative recovery,&#xD;
      pain control, absence of adverse effects and ease of performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pain control and quality life.VErbal rating scale and QoR15</measure>
    <time_frame>24 postoperative hours</time_frame>
    <description>Our work hypothesis is based on evaluating whether serratus-intercostal plane block (VNS)(SIPB or modified BRILMA) is similar or better than quadratus lumborum block type 2 (QL2) in items of quality and pain control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>48 hours</time_frame>
    <description>Second outcomes will be to value side effects and ease-performing in both techniques (PONV, hipothension, ...)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>control</measure>
    <time_frame>24</time_frame>
    <description>Third outcome will be to know if both blocks control pain better than control group</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Kidney Injury</condition>
  <arm_group>
    <arm_group_label>SIPB (block)</arm_group_label>
    <description>Patients undergone nephectomy and who received SIPB as analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QL block</arm_group_label>
    <description>Patients undergone nephectomy and who received QL as analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Patients undergone nephrectomy who didn´t receive regional anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound device</intervention_name>
    <description>We performe a differnt analgesic techniques to know if some of then are better</description>
    <arm_group_label>QL block</arm_group_label>
    <arm_group_label>SIPB (block)</arm_group_label>
    <other_name>device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine</intervention_name>
    <description>using the same AL</description>
    <arm_group_label>QL block</arm_group_label>
    <arm_group_label>SIPB (block)</arm_group_label>
    <other_name>drug</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A sample size of 80 patients (40 in each group) has been calculated assuming that we intend&#xD;
        to confirm a 15% improvement in pain control and postoperative recovery in the&#xD;
        serratus-intercostal plane block group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signature of informed consent&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  ASA risk scale &lt; IV&#xD;
&#xD;
          -  Scheduled to nephrectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive impairment or inability to sign informed consent,&#xD;
&#xD;
          -  Refused to participate&#xD;
&#xD;
          -  Hypersensitivity to the drugs used&#xD;
&#xD;
          -  contraindication of regional technique (coagulopathy, infection)&#xD;
&#xD;
          -  history of chronic pain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Teresa Fernandez</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Medina del Campo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>María T Fernandez</last_name>
    <phone>637571685</phone>
    <email>maitefm70@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>María Teresa Fernandez</name>
      <address>
        <city>Valladolid</city>
        <state>VA</state>
        <zip>47008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María T Fernandez</last_name>
      <phone>+34637571685</phone>
      <email>maitefm70@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Ultrasound-guided transmuscular quadratus lumborum block for perioperative analgesia in open nephrectomy. Minerva Anestesiol. 2017 Dec;83(12):1334-1335. doi: 10.23736/S0375-9393.17.12167-X. Epub 2017 Jul 5. No abstract available.</citation>
    <PMID>28679202</PMID>
  </reference>
  <reference>
    <citation>Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Transmuscular quadratus lumborum block versus serratus-intercostal interfascial plane block: the game has just begun. Minerva Anestesiol. 2018 Jul;84(7):873-874. doi: 10.23736/S0375-9393.18.12849-5. Epub 2018 Mar 27. No abstract available.</citation>
    <PMID>29589427</PMID>
  </reference>
  <reference>
    <citation>Fernandez Martin MT, Lopez Alvarez S, Fajardo Perez M, Perez Herrero M. Serratus-intercostal interfascial plane block: alternative analgesia for open nephrectomy? Minerva Anestesiol. 2018 Jul;84(7):872-873. doi: 10.23736/S0375-9393.18.12808-2. Epub 2018 Feb 22. No abstract available.</citation>
    <PMID>29479932</PMID>
  </reference>
  <reference>
    <citation>Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.</citation>
    <PMID>29789137</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Medina del Campo</investigator_affiliation>
    <investigator_full_name>María Teresa Fernandez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>postoperative analgesia</keyword>
  <keyword>fascial blocks</keyword>
  <keyword>nephectomy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04431388
org study id: CASVE-NM-20-434
secondary id: 2020-000779-19
nct id: NCT04431388
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain,
      but there are still some patients who describe a severe pain after this surgery. Regional
      techniques allow a better recovery quality and adequate- managed pain control.
Adequate control of pain in patients with nephrectomy is a challenge for the anesthesiologist
      who must achieve an early recovery with minimal adverse effects. Within a multimodal
      strategy, the work hypothesis is based on comparing the analgesic efficacy of two regional
      techniques in patients undergoing nephrectomy, in terms of quality of postoperative recovery,
      pain control, absence of adverse effects and ease of performance.
observational model: Cohort
time perspective: Prospective
measure: pain control and quality life.VErbal rating scale and QoR15
time frame: 24 postoperative hours
description: Our work hypothesis is based on evaluating whether serratus-intercostal plane block (VNS)(SIPB or modified BRILMA) is similar or better than quadratus lumborum block type 2 (QL2) in items of quality and pain control.
measure: side effects
time frame: 48 hours
description: Second outcomes will be to value side effects and ease-performing in both techniques (PONV, hipothension, ...)
measure: control
time frame: 24
description: Third outcome will be to know if both blocks control pain better than control group
arm group label: SIPB (block)
description: Patients undergone nephectomy and who received SIPB as analgesia
arm group label: QL block
description: Patients undergone nephectomy and who received QL as analgesia
arm group label: control
description: Patients undergone nephrectomy who didn´t receive regional anesthesia
intervention type: Device
intervention name: ultrasound device
description: We performe a differnt analgesic techniques to know if some of then are better
arm group label: QL block
arm group label: SIPB (block)
other name: device
intervention type: Drug
intervention name: Levobupivacaine
description: using the same AL
arm group label: QL block
arm group label: SIPB (block)
other name: drug
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Teresa Fernandez
role: Study Chair
affiliation: Hospital Medina del Campo
last name: María T Fernandez
phone: 637571685
email: maitefm70@hotmail.com
facility: 
status: Recruiting
contact: 
country: Spain
citation: Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Ultrasound-guided transmuscular quadratus lumborum block for perioperative analgesia in open nephrectomy. Minerva Anestesiol. 2017 Dec;83(12):1334-1335. doi: 10.23736/S0375-9393.17.12167-X. Epub 2017 Jul 5. No abstract available.
PMID: 28679202
citation: Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Transmuscular quadratus lumborum block versus serratus-intercostal interfascial plane block: the game has just begun. Minerva Anestesiol. 2018 Jul;84(7):873-874. doi: 10.23736/S0375-9393.18.12849-5. Epub 2018 Mar 27. No abstract available.
PMID: 29589427
citation: Fernandez Martin MT, Lopez Alvarez S, Fajardo Perez M, Perez Herrero M. Serratus-intercostal interfascial plane block: alternative analgesia for open nephrectomy? Minerva Anestesiol. 2018 Jul;84(7):872-873. doi: 10.23736/S0375-9393.18.12808-2. Epub 2018 Feb 22. No abstract available.
PMID: 29479932
citation: Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
PMID: 29789137
responsible party type: Principal Investigator
investigator affiliation: Hospital Medina del Campo
investigator full name: María Teresa Fernandez
investigator title: Principal Investigator
mesh term: Levobupivacaine
sharing ipd: Undecided