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/NCT06033456</url>
    </required_header>
    <id_info>
      <org_study_id>AP2302-301-0001</org_study_id>
      <nct_id>NCT06033456</nct_id>
    </id_info>
    <brief_title>Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome</brief_title>
    <official_title>Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, 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>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 aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US)&#xD;
        guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral&#xD;
        block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome&#xD;
        (PMPS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is the most common malignancy among females, with an incidence of about 2.1&#xD;
        million women each year. It is the most common cause of cancer-related deaths among women.&#xD;
        Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer.&#xD;
        It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients&#xD;
        experience severe acute postoperative pain, with severe pain persisting for 6-12 months in&#xD;
        almost 20-50% of patients (post-mastectomy pain syndrome.&#xD;
  &#xD;
        Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable&#xD;
        presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy&#xD;
        (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated&#xD;
        with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms&#xD;
        include severe pain, sensitivity to light touch, burning, sweating, skin discoloration,&#xD;
        edema, temperature changes, loss of motor function, and decreased range of motion of the&#xD;
        affected limb. The mechanism of CRPS is not fully understood with central and peripheral&#xD;
        sensitization involved.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The degree of pain relief</measure>
      <time_frame>3 months after intervention</time_frame>
      <description>Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention.&#xD;
  Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>3 months after intervention</time_frame>
      <description>Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxycodone consumption</measure>
      <time_frame>3 months after intervention</time_frame>
      <description>The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pregabalin consumption</measure>
      <time_frame>3 months after intervention</time_frame>
      <description>The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>neuropathic pain</measure>
      <time_frame>3 months</time_frame>
      <description>Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP).&#xD;
  Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) .&#xD;
  The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's Quality of life</measure>
      <time_frame>3 months</time_frame>
      <description>Patient's Quality of life according to WHOQOL(who measure quality of life)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Stellate Ganglion</condition>
    <condition>Radiofrequency Ablation</condition>
    <condition>Complex Regional Pain Syndromes</condition>
    <condition>Mastectomy</condition>
    <arm_group>
      <arm_group_label>Radiofrequency stellate ganglion block using ultrasound guidance (SGB)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Visualization of the C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex.&#xD;
  Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Radiofrequency stellate ganglion block using ultrasound guidance (SGB)</intervention_name>
      <description>Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8).&#xD;
  Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning</description>
      <arm_group_label>Radiofrequency stellate ganglion block using ultrasound guidance (SGB)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)</intervention_name>
      <description>Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.</description>
      <arm_group_label>Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block</intervention_name>
      <description>Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.</description>
      <arm_group_label>Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients.&#xD;
  &#xD;
            -  Type of surgery: Modified Radical Mastectomy MRM.&#xD;
  &#xD;
            -  Physical status ASA II, III.&#xD;
  &#xD;
            -  Duration of more than 6 months and less than 2 years.&#xD;
  &#xD;
            -  Moderate and severe pain (visual analog scale [VAS] ≥ 40 mm).&#xD;
  &#xD;
            -  Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such&#xD;
               as(pregabalin) for which more invasive interventions could be tried.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal.&#xD;
  &#xD;
            -  Patient with local and systemic sepsis.&#xD;
  &#xD;
            -  Local anatomical distortion.&#xD;
  &#xD;
            -  History of contralateral chest disease or pneumonectomy.&#xD;
  &#xD;
            -  Known sensitivity or contraindication to the drug used in the study.&#xD;
  &#xD;
            -  History of psychological disorders.&#xD;
  &#xD;
            -  Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies&#xD;
               and coagulopathy.&#xD;
  &#xD;
            -  Severe respiratory or cardiac disorders. Advanced liver or kidney disease.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Physical status ASA IV and Male patients.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female patients.&#xD;
  Type of surgery: Modified Radical Mastectomy MRM.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mary S Gerges</last_name>
      <phone>00201222610774</phone>
      <email>Marysabry136@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Cancer Institute</name>
        <address>
          <city>Cairo</city>
          <zip>11796</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Mary S Gerges, MD</last_name>
        <phone>00201222610774</phone>
        <email>Marysabry136@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Mahmoud A Kamel, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Taher S Thabet, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Suzan A Abdel rahman, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hossam Z Ghobrial, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Cancer Institute, Egypt</investigator_affiliation>
      <investigator_full_name>Mary Sabry</investigator_full_name>
      <investigator_title>Assistant lecturer of Anesthesia, ICU and Pain Management</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ganglion Cysts</mesh_term>
      <mesh_term>Synovial Cyst</mesh_term>
      <mesh_term>Complex Regional Pain Syndromes</mesh_term>
      <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author.</ipd_access_criteria>
    </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/NCT06033456
  org study id: AP2302-301-0001
  nct id: NCT06033456
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US)
        guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral
        block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome
        (PMPS).
  Breast cancer is the most common malignancy among females, with an incidence of about 2.1
        million women each year. It is the most common cause of cancer-related deaths among women.
        Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer.
        It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients
        experience severe acute postoperative pain, with severe pain persisting for 6-12 months in
        almost 20-50% of patients (post-mastectomy pain syndrome.
  
        Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable
        presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy
        (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated
        with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms
        include severe pain, sensitivity to light touch, burning, sweating, skin discoloration,
        edema, temperature changes, loss of motor function, and decreased range of motion of the
        affected limb. The mechanism of CRPS is not fully understood with central and peripheral
        sensitization involved.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The degree of pain relief
  time frame: 3 months after intervention
  description: Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention.
  Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.
  measure: Patient satisfaction
  time frame: 3 months after intervention
  description: Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
  measure: Oxycodone consumption
  time frame: 3 months after intervention
  description: The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.
  measure: Pregabalin consumption
  time frame: 3 months after intervention
  description: The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.
  measure: neuropathic pain
  time frame: 3 months
  description: Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP).
  Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) .
  The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)
  measure: Patient's Quality of life
  time frame: 3 months
  description: Patient's Quality of life according to WHOQOL(who measure quality of life)
  arm group label: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
  arm group type: Experimental
  description: Visualization of the C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex.
  Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning .
  arm group label: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance
  arm group type: Experimental
  description: Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.
  arm group label: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
  arm group type: Experimental
  description: Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.
  intervention type: Procedure
  intervention name: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
  description: Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8).
  Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning
  arm group label: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)
  intervention type: Procedure
  intervention name: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)
  description: Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.
  arm group label: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance
  intervention type: Procedure
  intervention name: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
  description: Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.
  arm group label: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female patients.
  Type of surgery: Modified Radical Mastectomy MRM.
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Mary S Gerges
  phone: 00201222610774
  email: Marysabry136@gmail.com
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: National Cancer Institute, Egypt
  investigator full name: Mary Sabry
  investigator title: Assistant lecturer of Anesthesia, ICU and Pain Management
  mesh term: Ganglion Cysts
  mesh term: Synovial Cyst
  mesh term: Complex Regional Pain Syndromes
  mesh term: Reflex Sympathetic Dystrophy
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author.