<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/NCT04442750</url>
  </required_header>
  <id_info>
    <org_study_id>N-29-2020</org_study_id>
    <nct_id>NCT04442750</nct_id>
  </id_info>
  <brief_title>Different Concentrations of Bupivacaine in Erector Spinae Plane Block in Hip Surgeries</brief_title>
  <official_title>Comparison of the Analgesic Efficacy of Three Different Concentrations of Bupivacaine in Ultrasound Guided Erector Spinae Plane Block in Hip Surgeries: Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      The prevalence of hip replacement surgery is increasing nowadays. Patients are usually older&#xD;
      age and suffer from comorbidities may be an anesthetic and analgesic challenge. Erector&#xD;
      spinae plane block (ESPB) is a newly described technique that is has been demonstrated in&#xD;
      previous studies for chronic and acute pain treatment. The exact volume and concentration of&#xD;
      local anesthetic (LA) to be used in ESPB is not well established.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the work is to compare the analgesic effects of three different concentrations of the&#xD;
      same volume of local anesthetics; 30 ml of 0.50% vs 0.375% vs 0.25% bupivacaine in patients&#xD;
      undergoing hip surgeries.&#xD;
&#xD;
      Prospective randomized double blinded study that will be conducted in at Kasr El-Ainy&#xD;
      hospital orthopedic surgical theater.&#xD;
&#xD;
      patients, undergoing hip surgeries will be randomly allocated into three equal groups, each&#xD;
      (n=44), using computerized generated random tables&#xD;
&#xD;
        1. Group F: 44 patients will receive single shot erector spinae block at the level of L4&#xD;
           with 30 ml 0.50% bupivacaine.&#xD;
&#xD;
        2. Group M: 44 patients will receive single shot erector spinae block at the level of L4&#xD;
           with 30 ml 0.375% bupivacaine.&#xD;
&#xD;
        3. Group H: 44 patients will receive single shot of erector spinae block at the level of&#xD;
           L4with 30ml 0.25% bupivacaine .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The total 24 hours amount of morphine consumption</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>The total amount of morphine consumption in the first 24 hours postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total amount of intraoperative fentanyl</measure>
    <time_frame>2 hours intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Numeric Pain Rating Scale, both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24 hours postoperatively. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for first rescue analgesia</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block related complications</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>• Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>A (0.5%) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B (0.375%) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C (0.25%) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae plane block Technique</intervention_name>
    <description>The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.</description>
    <arm_group_label>A (0.5%) group</arm_group_label>
    <arm_group_label>B (0.375%) group</arm_group_label>
    <arm_group_label>C (0.25%) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.&#xD;
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\kg will be provided every 30 minutes.&#xD;
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.&#xD;
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.</description>
    <arm_group_label>A (0.5%) group</arm_group_label>
    <arm_group_label>B (0.375%) group</arm_group_label>
    <arm_group_label>C (0.25%) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.5%</intervention_name>
    <description>The patient will receive 30ml bupivacain 0.5% in erector spinae block</description>
    <arm_group_label>A (0.5%) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.375%</intervention_name>
    <description>The patient will receive 30ml bupivacain 0.375% in erector spinae block</description>
    <arm_group_label>B (0.375%) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.25%</intervention_name>
    <description>The patient will receive 30ml bupivacain 0.25% in erector spinae block</description>
    <arm_group_label>C (0.25%) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders (Males and females).&#xD;
&#xD;
          -  Type of surgery; unilateral elective hip surgeries&#xD;
&#xD;
          -  Physical status ASA I, II.&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 65 Years.&#xD;
&#xD;
          -  Body mass index (BMI): &gt; 20 kg/m2 and &lt; 35 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known sensitivity or contraindication to drug used in the study (local&#xD;
             anesthetics, opioids).&#xD;
&#xD;
          -  History of psychological disorders and/or chronic pain.&#xD;
&#xD;
          -  Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral&#xD;
             neuropathies and coagulopathy.&#xD;
&#xD;
          -  Infection of the skin at the site of needle puncture area.&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Severe respiratory or cardiac disorders.&#xD;
&#xD;
          -  Advanced liver or kidney disease.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patient with surgery duration more than two hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bassant abdelhamid, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bassant abdelhamid, M.D.</last_name>
    <phone>01224254012</phone>
    <email>bassantmohamed197@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bassant M. Abdelhamid, M. D.</last_name>
      <phone>01224254012</phone>
      <phone_ext>002</phone_ext>
      <email>Bassantmohamed197@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.</citation>
    <PMID>29522966</PMID>
  </reference>
  <reference>
    <citation>Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.</citation>
    <PMID>30662115</PMID>
  </reference>
  <reference>
    <citation>Kashani HH, Grocott HP. Clarity needed as to the optimal dose and volume of local anesthetic for erector spinae plane blockade for posterior rib fractures. Am J Emerg Med. 2018 Jun;36(6):1102-1103. doi: 10.1016/j.ajem.2018.03.032. Epub 2018 Mar 15. No abstract available.</citation>
    <PMID>29576256</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Bassant M. Abdelhamid</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04442750
org study id: N-29-2020
nct id: NCT04442750
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of hip replacement surgery is increasing nowadays. Patients are usually older
      age and suffer from comorbidities may be an anesthetic and analgesic challenge. Erector
      spinae plane block (ESPB) is a newly described technique that is has been demonstrated in
      previous studies for chronic and acute pain treatment. The exact volume and concentration of
      local anesthetic (LA) to be used in ESPB is not well established.
Aim of the work is to compare the analgesic effects of three different concentrations of the
      same volume of local anesthetics; 30 ml of 0.50% vs 0.375% vs 0.25% bupivacaine in patients
      undergoing hip surgeries.

      Prospective randomized double blinded study that will be conducted in at Kasr El-Ainy
      hospital orthopedic surgical theater.

      patients, undergoing hip surgeries will be randomly allocated into three equal groups, each
      (n=44), using computerized generated random tables

        1. Group F: 44 patients will receive single shot erector spinae block at the level of L4
           with 30 ml 0.50% bupivacaine.

        2. Group M: 44 patients will receive single shot erector spinae block at the level of L4
           with 30 ml 0.375% bupivacaine.

        3. Group H: 44 patients will receive single shot of erector spinae block at the level of
           L4with 30ml 0.25% bupivacaine .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The total 24 hours amount of morphine consumption
time frame: 24 hours postoperative
description: The total amount of morphine consumption in the first 24 hours postoperatively
measure: Total amount of intraoperative fentanyl
time frame: 2 hours intraoperatively
measure: Numeric Pain Rating Scale
time frame: 24 hours postoperative
description: Numeric Pain Rating Scale, both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24 hours postoperatively. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which the patient rates the pain from 0 (no pain) to 10 (worst pain).
measure: Time for first rescue analgesia
time frame: 24 hours
measure: Block related complications
time frame: 24 hours postoperative
description: • Block related complications such as local anesthetic toxicity, hematoma formation and lower limb weakness.
arm group label: A (0.5%) group
arm group type: Experimental
description: patients will receive a single shot erector spinae block with 30 ml 0.5% bupivacaine followed by general anesthesia
arm group label: B (0.375%) group
arm group type: Experimental
description: patients will receive a single shot erector spinae block with 30 ml 0.375% bupivacaine followed by general anesthesia
arm group label: C (0.25%) group
arm group type: Experimental
description: patients will receive a single shot erector spinae block with 30 ml 0.25% bupivacaine followed by general anesthesia
intervention type: Procedure
intervention name: Erector spinae plane block Technique
description: The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
arm group label: A (0.5%) group
arm group label: B (0.375%) group
arm group label: C (0.25%) group
intervention type: Procedure
intervention name: General anesthesia
description: Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\kg will be provided every 30 minutes.
Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes.
arm group label: A (0.5%) group
arm group label: B (0.375%) group
arm group label: C (0.25%) group
intervention type: Drug
intervention name: Bupivacaine 0.5%
description: The patient will receive 30ml bupivacain 0.5% in erector spinae block
arm group label: A (0.5%) group
intervention type: Drug
intervention name: Bupivacaine 0.375%
description: The patient will receive 30ml bupivacain 0.375% in erector spinae block
arm group label: B (0.375%) group
intervention type: Drug
intervention name: Bupivacaine 0.25%
description: The patient will receive 30ml bupivacain 0.25% in erector spinae block
arm group label: C (0.25%) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bassant abdelhamid, M.D.
role: Principal Investigator
affiliation: Cairo University
last name: Bassant abdelhamid, M.D.
phone: 01224254012
email: bassantmohamed197@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
PMID: 29522966
citation: Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
PMID: 30662115
citation: Kashani HH, Grocott HP. Clarity needed as to the optimal dose and volume of local anesthetic for erector spinae plane blockade for posterior rib fractures. Am J Emerg Med. 2018 Jun;36(6):1102-1103. doi: 10.1016/j.ajem.2018.03.032. Epub 2018 Mar 15. No abstract available.
PMID: 29576256
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Bassant M. Abdelhamid
investigator title: associate professor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No