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/NCT06021327</url>
    </required_header>
    <id_info>
      <org_study_id>MD-327-2022</org_study_id>
      <nct_id>NCT06021327</nct_id>
    </id_info>
    <brief_title>Comparison Between Erector Spinae Plane Block And Retrolaminar Block In Patients Undergoing VATS.</brief_title>
    <official_title>Comparison Of The Analgesic Effect Of Ultrasound-Guided Erector Spinae Plane Block And Ultrasound-Guided Retrolaminar Block In Patients Undergoing Video Assisted Thoracoscopic Surgery: A Prospective, Randomized Study.</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Post-Video-assisted thoracoscopic surgery pain is a challenging clinical problem that may be&#xD;
        associated with increased morbidity and mortality. The current study tests two techniques of&#xD;
        regional anaesthesia to control post Video-assisted thoracoscopic surgery pain&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Video-assisted thoracoscopic surgery (VATS) is increasingly being used to manage primary lung&#xD;
        cancer and helps reduce postoperative pain. However, it is a fact that pain following VATS&#xD;
        can be severe and long-lasting. According to previous study, 18.8% of patients who undergo&#xD;
        VATS present with persistent pain 2 months after surgery .The provision of pain relief is a&#xD;
        significant consideration, and thoracic epidural analgesia is often regarded to be the gold&#xD;
        standard. However, epidural analgesia is not always ideal, and other practical regional&#xD;
        methods of analgesia after VATS have been proposed as Erector Spinae Plane Block (ESPB) or&#xD;
        retrolaminar block (RLB) .&#xD;
  &#xD;
        The retrolaminar block (RLB) is a modified paravertebral block that administers local&#xD;
        anesthetic between the lamina of the thoracic vertebra and the erector spinal muscles, using&#xD;
        landmark technique or under ultrasound guidance. Previous clinical study reported that RLB&#xD;
        provides a good analgesic effect after VATS but was inferior to para-vertebral block(PVB).&#xD;
  &#xD;
        Erector spinae plane block (ESPB) is a relatively new interfascial block procedure first&#xD;
        described for thoracic analgesia. Previous clinical studies reported that ESPB provides a&#xD;
        good analgesic effect after VATS (comparable with PVB) and decreases morphine consumption&#xD;
        after Lateral thoracotomy surgery. Thus, anaesthesiologists now have a greater choice for&#xD;
        regional anaesthesia for thoracic analgesia. Although ESPB and RLB have similar puncture&#xD;
        sites, Only one clinical study comparing ESPB and RLB in breast surgery has been reported ,&#xD;
        The mentioned study was also limited only to female patients. both blocks were compared with&#xD;
        PVB but There is no clinical study that compares ESPB and RLB directly in VATS. Although the&#xD;
        mechanisms of action of both ESPB and RLB have not yet been completely clarified, one&#xD;
        cadaveric study indicated that ESPB leads to a broader spread of the local analgesic into a&#xD;
        more extensive range of intercostal spaces from a single point of injection than RLB .&#xD;
        Another cadaveric study reported that the lateral pathway, which is involved in the blockade&#xD;
        of the intercostal nerve or the lateral cutaneous branches of the intercostal nerves, is the&#xD;
        primary mechanism of ESPB, in contrast to RLB.&#xD;
  &#xD;
        Based on these anatomical studies, we hypothesize that ESPB can be superior to RLB for&#xD;
        postoperative analgesia after VATS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Prevention</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I (E) will receive a US-guided ESPB, while Group II (R) will receive a US-guided RLB. An anesthesiologist who is not involved in the data collection team will perform all nerve blocks. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups</measure>
      <time_frame>24-hour</time_frame>
      <description>ESPB compared to RLB for postoperative analgesia after VATS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>• Time is required to perform the technique in minutes.</measure>
      <time_frame>intraoperative</time_frame>
      <description>between the start of US scanning and the local anesthetic injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>intraoperative and 24 hours postoperative</time_frame>
      <description>Heart rate (Bpm) at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic arterial blood pressure</measure>
      <time_frame>intraoperative and 24 hours postoperative</time_frame>
      <description>Systolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diastolic arterial blood pressure</measure>
      <time_frame>intraoperative and 24 hours postoperative</time_frame>
      <description>Diastolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean arterial blood pressure</measure>
      <time_frame>intraoperative and 24 hours postoperative</time_frame>
      <description>Mean arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Intraoperative cardioactive drug use</measure>
      <time_frame>Intraoperative</time_frame>
      <description>The number of patients requiring ephedrine and atropine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Intraoperative analgesics</measure>
      <time_frame>Intraoperative</time_frame>
      <description>The number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram )</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Pain score according to VAS score</measure>
      <time_frame>24 hours</time_frame>
      <description>VAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• First request of analgesia postoperative</measure>
      <time_frame>24 hours Postoperative</time_frame>
      <description>The elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Incidence of side effects related to opioid use</measure>
      <time_frame>24 hours Postoperative</time_frame>
      <description>(postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Incidence of complications or side-effects related to the block</measure>
      <time_frame>24 hours</time_frame>
      <description>(bradycardia, hypotension, hematoma formation or intravascular injection).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Post-operative Analgesia</condition>
    <condition>Retrolaminar Block</condition>
    <condition>Erector Spinae Plan Block</condition>
    <condition>VATS</condition>
    <arm_group>
      <arm_group_label>Erector spinae plane block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will receive a US-guided ESPB</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Retrolaminar block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>will receive a US-guided RLB</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Erector spinae plane block</intervention_name>
      <description>Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 3 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact the tip of the T4 transverse process , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. Adequacy of the block will be confirmed by ultrasonographic visualization of fluid spread (seen as a lifting of the erector spina muscles in both block) and after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.</description>
      <arm_group_label>Erector spinae plane block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Retrolaminar block</intervention_name>
      <description>Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 1 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact T4 lamina of the vertebra , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. And after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.</description>
      <arm_group_label>Retrolaminar block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status class (ASA) I, II and III&#xD;
  &#xD;
            -  Patients undergoing VATS.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient refusal&#xD;
  &#xD;
            2. Coagulopathy, bleeding disorders,&#xD;
  &#xD;
            3. In-ability to postpone anti-coagulation medications.&#xD;
  &#xD;
            4. infection at the injection site&#xD;
  &#xD;
            5. pregnancy, breastfeeding,&#xD;
  &#xD;
            6. severe obesity (body mass index &gt; 35 kg/m2 )&#xD;
  &#xD;
            7. allergy to any drug used in the study&#xD;
  &#xD;
            8. preoperative daily use of a non-steroidal anti-inflammatory drug (NSAID) or opioids,&#xD;
  &#xD;
            9. Previous surgery in the thoracic vertebral region&#xD;
  &#xD;
           10. Liver dysfunction.&#xD;
  &#xD;
           11. Injury or a lesion at the block site.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Islam M Sayed, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Islam M Sayed, MS</last_name>
      <phone>00201008039448</phone>
      <email>i.sharr866@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Facalty of Medicine - Cairo University</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Islam M Sayed, MS</last_name>
        <phone>00201008039448</phone>
        <email>i.sharr866@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Falcoz PE, Puyraveau M, Thomas PA, Decaluwe H, Hurtgen M, Petersen RH, Hansen H, Brunelli A; ESTS Database Committee and ESTS Minimally Invasive Interest Group. Video-assisted thoracoscopic surgery versus open lobectomy for primary non-small-cell lung cancer: a propensity-matched analysis of outcome from the European Society of Thoracic Surgeon database. Eur J Cardiothorac Surg. 2016 Feb;49(2):602-9. doi: 10.1093/ejcts/ezv154. Epub 2015 Apr 26.</citation>
      <PMID>25913824</PMID>
    </reference>
    <reference>
      <citation>Landreneau RJ, Mack MJ, Hazelrigg SR, Naunheim K, Dowling RD, Ritter P, Magee MJ, Nunchuck S, Keenan RJ, Ferson PF. Prevalence of chronic pain after pulmonary resection by thoracotomy or video-assisted thoracic surgery. J Thorac Cardiovasc Surg. 1994 Apr;107(4):1079-85; discussion 1085-6. doi: 10.1097/00132586-199412000-00051.</citation>
      <PMID>8159030</PMID>
    </reference>
    <reference>
      <citation>Homma T, Doki Y, Yamamoto Y, Ojima T, Shimada Y, Kitamura N, Yoshimura N. Risk factors of neuropathic pain after thoracic surgery. J Thorac Dis. 2018 May;10(5):2898-2907. doi: 10.21037/jtd.2018.05.25.</citation>
      <PMID>29997955</PMID>
    </reference>
    <reference>
      <citation>Crumley S, Schraag S. The role of local anaesthetic techniques in ERAS protocols for thoracic surgery. J Thorac Dis. 2018 Mar;10(3):1998-2004. doi: 10.21037/jtd.2018.02.48.</citation>
      <PMID>29707356</PMID>
    </reference>
    <reference>
      <citation>Shim JG, Ryu KH, Kim PO, Cho EA, Ahn JH, Yeon JE, Lee SH, Kang DY. Evaluation of ultrasound-guided erector spinae plane block for postoperative management of video-assisted thoracoscopic surgery: a prospective, randomized, controlled clinical trial. J Thorac Dis. 2020 Aug;12(8):4174-4182. doi: 10.21037/jtd-20-689.</citation>
      <PMID>32944329</PMID>
    </reference>
    <reference>
      <citation>Pfeiffer G, Oppitz N, Schone S, Richter-Heine I, Hohne M, Koltermann C. [Analgesia of the axilla using a paravertebral catheter in the lamina technique]. Anaesthesist. 2006 Apr;55(4):423-7. doi: 10.1007/s00101-005-0969-0. German.</citation>
      <PMID>16404582</PMID>
    </reference>
    <reference>
      <citation>Wang Q, Wei S, Li S, Yu J, Zhang G, Ni C, Sun L, Zheng H. Comparison of the analgesic effect of ultrasound-guided paravertebral block and ultrasound-guided retrolaminar block in Uniportal video-assisted Thoracoscopic surgery: a prospective, randomized study. BMC Cancer. 2021 Nov 16;21(1):1229. doi: 10.1186/s12885-021-08938-7.</citation>
      <PMID>34784889</PMID>
    </reference>
    <reference>
      <citation>Taketa Y, Irisawa Y, Fujitani T. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after video-assisted thoracic surgery: a randomized controlled non-inferiority clinical trial. Reg Anesth Pain Med. 2019 Nov 8:rapm-2019-100827. doi: 10.1136/rapm-2019-100827. Online ahead of print.</citation>
      <PMID>31704789</PMID>
    </reference>
    <reference>
      <citation>Chen N, Qiao Q, Chen R, Xu Q, Zhang Y, Tian Y. The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial. J Clin Anesth. 2020 Feb;59:106-111. doi: 10.1016/j.jclinane.2019.07.002. Epub 2019 Jul 19.</citation>
      <PMID>31330457</PMID>
    </reference>
    <reference>
      <citation>Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.</citation>
      <PMID>30665850</PMID>
    </reference>
    <reference>
      <citation>Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.</citation>
      <PMID>32915300</PMID>
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      <citation>Adhikary SD, Bernard S, Lopez H, Chin KJ. Erector Spinae Plane Block Versus Retrolaminar Block: A Magnetic Resonance Imaging and Anatomical Study. Reg Anesth Pain Med. 2018 Oct;43(7):756-762. doi: 10.1097/AAP.0000000000000798.</citation>
      <PMID>29794943</PMID>
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      <citation>Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.</citation>
      <PMID>29746445</PMID>
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      <citation>Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block. Biomed Res Int. 2019 Mar 28;2019:2578396. doi: 10.1155/2019/2578396. eCollection 2019.</citation>
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      <citation>Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Islam M Sayed</investigator_full_name>
      <investigator_title>i.sharr866@gmail.com</investigator_title>
    </responsible_party>
    <keyword>RLB</keyword>
    <keyword>ESPB</keyword>
    <keyword>VATS</keyword>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>November 12, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT06021327/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06021327
  org study id: MD-327-2022
  nct id: NCT06021327
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Post-Video-assisted thoracoscopic surgery pain is a challenging clinical problem that may be
        associated with increased morbidity and mortality. The current study tests two techniques of
        regional anaesthesia to control post Video-assisted thoracoscopic surgery pain
  Video-assisted thoracoscopic surgery (VATS) is increasingly being used to manage primary lung
        cancer and helps reduce postoperative pain. However, it is a fact that pain following VATS
        can be severe and long-lasting. According to previous study, 18.8% of patients who undergo
        VATS present with persistent pain 2 months after surgery .The provision of pain relief is a
        significant consideration, and thoracic epidural analgesia is often regarded to be the gold
        standard. However, epidural analgesia is not always ideal, and other practical regional
        methods of analgesia after VATS have been proposed as Erector Spinae Plane Block (ESPB) or
        retrolaminar block (RLB) .
  
        The retrolaminar block (RLB) is a modified paravertebral block that administers local
        anesthetic between the lamina of the thoracic vertebra and the erector spinal muscles, using
        landmark technique or under ultrasound guidance. Previous clinical study reported that RLB
        provides a good analgesic effect after VATS but was inferior to para-vertebral block(PVB).
  
        Erector spinae plane block (ESPB) is a relatively new interfascial block procedure first
        described for thoracic analgesia. Previous clinical studies reported that ESPB provides a
        good analgesic effect after VATS (comparable with PVB) and decreases morphine consumption
        after Lateral thoracotomy surgery. Thus, anaesthesiologists now have a greater choice for
        regional anaesthesia for thoracic analgesia. Although ESPB and RLB have similar puncture
        sites, Only one clinical study comparing ESPB and RLB in breast surgery has been reported ,
        The mentioned study was also limited only to female patients. both blocks were compared with
        PVB but There is no clinical study that compares ESPB and RLB directly in VATS. Although the
        mechanisms of action of both ESPB and RLB have not yet been completely clarified, one
        cadaveric study indicated that ESPB leads to a broader spread of the local analgesic into a
        more extensive range of intercostal spaces from a single point of injection than RLB .
        Another cadaveric study reported that the lateral pathway, which is involved in the blockade
        of the intercostal nerve or the lateral cutaneous branches of the intercostal nerves, is the
        primary mechanism of ESPB, in contrast to RLB.
  
        Based on these anatomical studies, we hypothesize that ESPB can be superior to RLB for
        postoperative analgesia after VATS.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  masking description: Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I (E) will receive a US-guided ESPB, while Group II (R) will receive a US-guided RLB. An anesthesiologist who is not involved in the data collection team will perform all nerve blocks. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol.
  measure: Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
  time frame: 24-hour
  description: ESPB compared to RLB for postoperative analgesia after VATS
  measure: • Time is required to perform the technique in minutes.
  time frame: intraoperative
  description: between the start of US scanning and the local anesthetic injection
  measure: Heart Rate
  time frame: intraoperative and 24 hours postoperative
  description: Heart rate (Bpm) at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
  measure: Systolic arterial blood pressure
  time frame: intraoperative and 24 hours postoperative
  description: Systolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
  measure: Diastolic arterial blood pressure
  time frame: intraoperative and 24 hours postoperative
  description: Diastolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
  measure: Mean arterial blood pressure
  time frame: intraoperative and 24 hours postoperative
  description: Mean arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
  measure: • Intraoperative cardioactive drug use
  time frame: Intraoperative
  description: The number of patients requiring ephedrine and atropine
  measure: • Intraoperative analgesics
  time frame: Intraoperative
  description: The number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram )
  measure: • Pain score according to VAS score
  time frame: 24 hours
  description: VAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
  measure: • First request of analgesia postoperative
  time frame: 24 hours Postoperative
  description: The elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours
  measure: • Incidence of side effects related to opioid use
  time frame: 24 hours Postoperative
  description: (postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time.
  measure: • Incidence of complications or side-effects related to the block
  time frame: 24 hours
  description: (bradycardia, hypotension, hematoma formation or intravascular injection).
  arm group label: Erector spinae plane block
  arm group type: Active Comparator
  description: will receive a US-guided ESPB
  arm group label: Retrolaminar block
  arm group type: Active Comparator
  description: will receive a US-guided RLB
  intervention type: Procedure
  intervention name: Erector spinae plane block
  description: Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 3 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact the tip of the T4 transverse process , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. Adequacy of the block will be confirmed by ultrasonographic visualization of fluid spread (seen as a lifting of the erector spina muscles in both block) and after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.
  arm group label: Erector spinae plane block
  intervention type: Procedure
  intervention name: Retrolaminar block
  description: Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 1 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact T4 lamina of the vertebra , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. And after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.
  arm group label: Retrolaminar block
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Islam M Sayed, MS
  role: Principal Investigator
  affiliation: Cairo University
  last name: Islam M Sayed, MS
  phone: 00201008039448
  email: i.sharr866@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
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  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Islam M Sayed
  investigator title: i.sharr866@gmail.com
  provided document: 