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/NCT06036979</url>
    </required_header>
    <id_info>
      <org_study_id>AP2303-301-0007</org_study_id>
      <nct_id>NCT06036979</nct_id>
    </id_info>
    <brief_title>A Comparative Study Between the Effectiveness of Preoperative ESPB Versus Preoperative PVPB in Decreasing PMPS. A Randomized Controlled Study</brief_title>
    <official_title>A Comparative Study Between the Effectiveness of Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cancer Institute, Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cancer Institute, Egypt</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Breast cancer is considered the commonest malignancy affecting women with an incidence&#xD;
        exceeding one million cases per year. Although it has a favorable prognosis with improved&#xD;
        lines of treatment, some complications may still disturb the patient's life quality. One of&#xD;
        these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is&#xD;
        considered one of the most effective methods in reducing acute pain after breast surgeries,&#xD;
        these include pectoral nerves block (PECS), serratus anterior plane block (SAPB),&#xD;
        paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming&#xD;
        for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of&#xD;
        PMPS in patients undergoing unilateral breast surgeries.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is considered the commonest malignancy affecting women with an incidence&#xD;
        exceeding one million cases per year. Although it has a favorable prognosis with improved&#xD;
        lines of treatment, some complications may still disturb the patient's life quality. One of&#xD;
        these complications is post-mastectomy pain syndrome (PMPS) ¹.&#xD;
  &#xD;
        The International Association for Study of Pain (IASP) defines PMPS as chronic pain that&#xD;
        persists more than 3 months in the anterior thorax, axilla &amp;/or upper arm ². It is usually&#xD;
        neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia,&#xD;
        allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is&#xD;
        usually of at least moderate intensity and may be either continuous or intermittent pain ³.&#xD;
  &#xD;
        The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are&#xD;
        believed to be associated with PMPS, including the presence and intensity of postoperative&#xD;
        pain, the type of surgery, younger women, prior history of other types of pain and adjuvant&#xD;
        therapies like chemo or radiotherapy ⁴.&#xD;
  &#xD;
        Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute&#xD;
        pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior&#xD;
        plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵.&#xD;
        Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive&#xD;
        input and central sensitization during the perioperative period, However clinically the role&#xD;
        of RA in preventing PMPS is still under investigations ⁶.&#xD;
  &#xD;
        PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves&#xD;
        exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal&#xD;
        pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads&#xD;
        of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane&#xD;
        between the vertebral transverse processes and the erector spinae muscle ⁸.&#xD;
  &#xD;
        Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling&#xD;
        acute postoperative pain after breast surgeries, some studies compared between them in&#xD;
        controlling acute postoperative pain after breast surgeries ⁹. Also there are some studies&#xD;
        that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast&#xD;
        surgeries ¹⁰, but still the comparison between the effect of preoperative ESPB versus the&#xD;
        effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries&#xD;
        is still under investigated.&#xD;
  &#xD;
        Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in&#xD;
        the prevention of PMPS in patients undergoing unilateral breast surgeries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome is to assess the incidence of PMPS 3 months after surgery.</measure>
      <time_frame>3 months</time_frame>
      <description>A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI).&#xD;
  Chronic pain is defined by a score of ≥ 3 on the single item (average pain) of the BPI.&#xD;
  The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>• The prevalence of PMPS at 6 months.</measure>
      <time_frame>6 months</time_frame>
      <description>• The prevalence of PMPS at 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Assessment of acute postoperative pain.</measure>
      <time_frame>48 hours</time_frame>
      <description>• Assessment of acute postoperative pain using VAS (0 for no pain, 10 for the worst pain) at 0, 4, 8, 24 and 48 hours postoperatively.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.</measure>
      <time_frame>48 hours .</time_frame>
      <description>• Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>• PVPB and ESPB related complications.</measure>
      <time_frame>24 hours</time_frame>
      <description>• PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Chronic Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Paravertebral Block Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Erector Spinae Block Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Paravertebral plane block</intervention_name>
      <description>With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.</description>
      <arm_group_label>Paravertebral Block Group</arm_group_label>
      <other_name>PVPB</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Erector spinae plane block</intervention_name>
      <description>With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.</description>
      <arm_group_label>Erector Spinae Block Group</arm_group_label>
      <other_name>ESPB</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years and ≤ 60 years old.&#xD;
  &#xD;
            -  Female patients ASA ΙΙ, ΙΙΙ.&#xD;
  &#xD;
            -  Female patients scheduled for unilateral breast surgeries.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal.&#xD;
  &#xD;
            -  Patients have sepsis&#xD;
  &#xD;
            -  Patients known to have allergy against local anesthetics.&#xD;
  &#xD;
            -  Patients with prior surgery in areas above or below the clavicle or in the axillary&#xD;
               region.&#xD;
  &#xD;
            -  Patients with opioid dependence, alcohol or drug abuse.&#xD;
  &#xD;
            -  Patient with coagulopathy.&#xD;
  &#xD;
            -  Patients with psychiatric illness that prevent them from proper pain perception and&#xD;
               assessment.&#xD;
  &#xD;
            -  ASA 4 or higher.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female patients ASA ΙΙ, ΙΙΙ between 18 and 60 years undergoing unilateral breast surgeries.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suzan Ahmed, MS degree</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Cancer Institute, Egypt</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzan Ahmed, MS degree in Anaesthesia</last_name>
      <phone>00201004610287</phone>
      <email>suzansayed@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>NCIEGYPT</name>
        <address>
          <city>Cairo</city>
          <zip>11796</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <link>
      <url>https://aimj.journals.ekb.eg/article_230793.html</url>
      <description>Comparative study between ultrasound guided erector spinae plane block versus paravertebral block for postoperative pain relief in patients undergoing unilateral modified radical mastectomy.AIMJ.2022.</description>
    </link>
    <reference>
      <citation>Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7.</citation>
      <PMID>33414157</PMID>
    </reference>
    <reference>
      <citation>Yuksel SS, Chappell AG, Jackson BT, Wescott AB, Ellis MF. &quot;Post Mastectomy Pain Syndrome: A Systematic Review of Prevention Modalities&quot;. JPRAS Open. 2021 Oct 30;31:32-49. doi: 10.1016/j.jpra.2021.10.009. eCollection 2022 Mar.</citation>
      <PMID>34926777</PMID>
    </reference>
    <reference>
      <citation>Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716.</citation>
      <PMID>27668333</PMID>
    </reference>
    <reference>
      <citation>Gong Y, Tan Q, Qin Q, Wei C. Prevalence of postmastectomy pain syndrome and associated risk factors: A large single-institution cohort study. Medicine (Baltimore). 2020 May;99(20):e19834. doi: 10.1097/MD.0000000000019834.</citation>
      <PMID>32443289</PMID>
    </reference>
    <reference>
      <citation>Xin L, Hou N, Zhang Z, Feng Y. The Effect of Preoperative Ultrasound-Guided Erector Spinae Plane Block on Chronic Postsurgical Pain After Breast Cancer Surgery: A Propensity Score-Matched Cohort Study. Pain Ther. 2022 Mar;11(1):93-106. doi: 10.1007/s40122-021-00339-9. Epub 2021 Nov 26.</citation>
      <PMID>34826113</PMID>
    </reference>
    <reference>
      <citation>Zinboonyahgoon N, Patton ME, Chen YK, Edwards RR, Schreiber KL. Persistent Post-Mastectomy Pain: The Impact of Regional Anesthesia Among Patients with High vs Low Baseline Catastrophizing. Pain Med. 2021 Aug 6;22(8):1767-1775. doi: 10.1093/pm/pnab039. Erratum In: Pain Med. 2022 Jan 3;23(1):225.</citation>
      <PMID>33560352</PMID>
    </reference>
    <reference>
      <citation>Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.</citation>
      <PMID>21804697</PMID>
    </reference>
    <reference>
      <citation>Bonvicini D, Boscolo-Berto R, De Cassai A, Negrello M, Macchi V, Tiberio I, Boscolo A, De Caro R, Porzionato A. Anatomical basis of erector spinae plane block: a dissection and histotopographic pilot study. J Anesth. 2021 Feb;35(1):102-111. doi: 10.1007/s00540-020-02881-w. Epub 2020 Dec 19.</citation>
      <PMID>33340344</PMID>
    </reference>
    <reference>
      <citation>El Ghamry MR, Amer AF. Role of erector spinae plane block versus paravertebral block in pain control after modified radical mastectomy. A prospective randomised trial. Indian J Anaesth. 2019 Dec;63(12):1008-1014. doi: 10.4103/ija.IJA_310_19. Epub 2019 Dec 11.</citation>
      <PMID>31879425</PMID>
    </reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PVPB, ESPB, prevention of PMPS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Study protocol will be shared</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>20 years</ipd_time_frame>
      <ipd_access_criteria>Clinical trials.gov</ipd_access_criteria>
      <ipd_url>http://clinicaltrials.gov</ipd_url>
    </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/NCT06036979
  org study id: AP2303-301-0007
  nct id: NCT06036979
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Breast cancer is considered the commonest malignancy affecting women with an incidence
        exceeding one million cases per year. Although it has a favorable prognosis with improved
        lines of treatment, some complications may still disturb the patient's life quality. One of
        these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is
        considered one of the most effective methods in reducing acute pain after breast surgeries,
        these include pectoral nerves block (PECS), serratus anterior plane block (SAPB),
        paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming
        for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of
        PMPS in patients undergoing unilateral breast surgeries.
  Breast cancer is considered the commonest malignancy affecting women with an incidence
        exceeding one million cases per year. Although it has a favorable prognosis with improved
        lines of treatment, some complications may still disturb the patient's life quality. One of
        these complications is post-mastectomy pain syndrome (PMPS) ¹.
  
        The International Association for Study of Pain (IASP) defines PMPS as chronic pain that
        persists more than 3 months in the anterior thorax, axilla &/or upper arm ². It is usually
        neuropathic in nature includes altered sensations such as dysesthesia, hypo or hyperesthesia,
        allodynia or particular qualities of dysesthesia e.g burning, dull aching sensations. It is
        usually of at least moderate intensity and may be either continuous or intermittent pain ³.
  
        The etiology and mechanism of PMPS remain incompletely clear yet. Some risk factors are
        believed to be associated with PMPS, including the presence and intensity of postoperative
        pain, the type of surgery, younger women, prior history of other types of pain and adjuvant
        therapies like chemo or radiotherapy ⁴.
  
        Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute
        pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior
        plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) ⁵.
        Theoretically RA can minimize the development of PMPS by decreasing the afferent nociceptive
        input and central sensitization during the perioperative period, However clinically the role
        of RA in preventing PMPS is still under investigations ⁶.
  
        PVPB includes injecting local anesthetic in the paravertebral space where the spinal nerves
        exit from the intervertebral foraminae. Paravertebral space is bounded by the parietal
        pleura, superior costotransverse ligament, vertebrae, intervertebral foraminae and the heads
        of the ribs ⁷. While ESPB includes injection of the local anesthetic in the fascial plane
        between the vertebral transverse processes and the erector spinae muscle ⁸.
  
        Many studies were done in order to evaluate the efficacy of either ESPB or PVB in controlling
        acute postoperative pain after breast surgeries, some studies compared between them in
        controlling acute postoperative pain after breast surgeries ⁹. Also there are some studies
        that evaluate the effect of either ESPB or PVPB in the prevention of PMPS after breast
        surgeries ¹⁰, but still the comparison between the effect of preoperative ESPB versus the
        effect of preoperative PVPB in the prevention of PMPS in patients undergoing breast surgeries
        is still under investigated.
  
        Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in
        the prevention of PMPS in patients undergoing unilateral breast surgeries.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The primary outcome is to assess the incidence of PMPS 3 months after surgery.
  time frame: 3 months
  description: A junior pain physician is blinded to all treatment groups and asks about symptoms of PMPS including (pain, tingling, numbness, shooting pain, pricking pain or unbearable itching), site (chest wall, armpit, arm, shoulder or surgical scar) and grading scale using the brief pain inventory (BPI).
  Chronic pain is defined by a score of ≥ 3 on the single item (average pain) of the BPI.
  The BPI consists of three domains: (1) Pain intensity measured using the visual analogue scale (VAS) of 0 (no pain) to 10 (worst pain). (2) Pain that interferes with daily activities measured using a scale of 0 (no interference) to 10 (complete restriction to daily activities). (3) Percentage of relief provided by pain treatments measured using a scale of 0 (complete relief) to 10 (no relief) by the NRS.
  measure: • The prevalence of PMPS at 6 months.
  time frame: 6 months
  description: • The prevalence of PMPS at 6 months.
  measure: • Assessment of acute postoperative pain.
  time frame: 48 hours
  description: • Assessment of acute postoperative pain using VAS (0 for no pain, 10 for the worst pain) at 0, 4, 8, 24 and 48 hours postoperatively.
  measure: • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
  time frame: 48 hours .
  description: • Time to first needed morphine dose postoperatively, total 24-48 hours morphine consumption.
  measure: • PVPB and ESPB related complications.
  time frame: 24 hours
  description: • PVPB and ESPB related complications (bupivacaine toxicity, pneumothorax).
  arm group label: Paravertebral Block Group
  arm group type: Active Comparator
  description: This group will receive combined general anaesthesia with preoperative ultrasound guide paravertebral plane block
  arm group label: Erector Spinae Block Group
  arm group type: Active Comparator
  description: This group will receive combined general anaesthesia with preoperative ultrasound guided erector spinae plane block
  arm group label: Control Group
  arm group type: No Intervention
  description: This group will receive balanced general anesthesia using intravenous (0.1mg/kg) morphine, 30 mg ketorlac and 1 gm paracetamol).
  intervention type: Procedure
  intervention name: Paravertebral plane block
  description: With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
  arm group label: Paravertebral Block Group
  other name: PVPB
  intervention type: Procedure
  intervention name: Erector spinae plane block
  description: With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
  arm group label: Erector Spinae Block Group
  other name: ESPB
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female patients ASA ΙΙ, ΙΙΙ between 18 and 60 years undergoing unilateral breast surgeries.
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Suzan Ahmed, MS degree
  role: Principal Investigator
  affiliation: National Cancer Institute, Egypt
  last name: Suzan Ahmed, MS degree in Anaesthesia
  phone: 00201004610287
  email: suzansayed@yahoo.com
  facility: 
  status: Recruiting
  country: Egypt
  url: https://aimj.journals.ekb.eg/article_230793.html
  description: Comparative study between ultrasound guided erector spinae plane block versus paravertebral block for postoperative pain relief in patients undergoing unilateral modified radical mastectomy.AIMJ.2022.
  citation: Harkouk H, Fletcher D, Martinez V. Paravertebral block for the prevention of chronic postsurgical pain after breast cancer surgery. Reg Anesth Pain Med. 2021 Mar;46(3):251-257. doi: 10.1136/rapm-2020-102040. Epub 2021 Jan 7.
  PMID: 33414157
  citation: Yuksel SS, Chappell AG, Jackson BT, Wescott AB, Ellis MF. "Post Mastectomy Pain Syndrome: A Systematic Review of Prevention Modalities". JPRAS Open. 2021 Oct 30;31:32-49. doi: 10.1016/j.jpra.2021.10.009. eCollection 2022 Mar.
  PMID: 34926777
  citation: Waltho D, Rockwell G. Post-breast surgery pain syndrome: establishing a consensus for the definition of post-mastectomy pain syndrome to provide a standardized clinical and research approach - a review of the literature and discussion. Can J Surg. 2016 Sep;59(5):342-50. doi: 10.1503/cjs.000716.
  PMID: 27668333
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  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  sharing ipd: Yes
  ipd description: Study protocol will be shared
  ipd info type: Study Protocol
  ipd time frame: 20 years
  ipd access criteria: Clinical trials.gov
  ipd url: http://clinicaltrials.gov