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/NCT05970146</url>
    </required_header>
    <id_info>
      <org_study_id>36264MD58/3/23</org_study_id>
      <nct_id>NCT05970146</nct_id>
    </id_info>
    <brief_title>Cervical Epidural and Stellate Ganglion Block in Upper Limb Complex Regional Pain Syndrome</brief_title>
    <official_title>Comparison Between Cervical Epidural and Stellate Ganglion Block in Management of Complex Regional Pain Syndrome of the Upper Limb A Prospective Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        Evaluate the efficacy of two regimens of management in relieving chronic refractory pain in&#xD;
        patients with upper limb complex regional pain syndrome after orthopedic trauma&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ideal therapy for Complex Regional Pain Syndrome is multimodal with the use of physical&#xD;
        therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures.&#xD;
        Within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory&#xD;
        drugs (NSAIDs), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and&#xD;
        N-methyl-D-aspartate (NMDA) receptor antagonists (i.e., Ketamine).&#xD;
  &#xD;
        In complex Regional Pain Syndrome treatment, stellate ganglion block (SGB) is a&#xD;
        well-established method of nerve blockade of the sympathetic ganglia in the lower cervical&#xD;
        and upper thoracic region.&#xD;
  &#xD;
        Epidural block have differential block as sensory, motor, and sympathetic. Nerve functions&#xD;
        are blunt at different rates and to different degrees. Sensory block occurs with a lower&#xD;
        concentration of Local anathesia and develops faster than motor block with coexisting&#xD;
        sympathectomy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>Phase 4</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 percent on satisfactory relief of pain</measure>
      <time_frame>6 month post injection</time_frame>
      <description>Numerical rating scales (NRS) is an 11-Point Scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being &quot;no pain&quot; and 10 being &quot;the worst pain imaginable.&#xD;
  NRS was measured before, immediately after injection, 3 and 6 month post injection.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The degree of chronic pain using Brief Pain Inventory</measure>
      <time_frame>6 month post injection</time_frame>
      <description>Brief Pain Inventory short form (BPI-SF) questionnaire. It is a nine item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, normal work, relations with other persons, sleep, and enjoyment of life on a 10 Point Scale&#xD;
  BPI-SF was measured before, immediately after injection, 3 and 6 month post injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of complication</measure>
      <time_frame>2 hours post-intervention</time_frame>
      <description>complications as hypotension, headache and neck pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Stellate Ganglion Block</condition>
    <condition>Cervical Epidural</condition>
    <condition>Complex Regional Pain Syndromes</condition>
    <arm_group>
      <arm_group_label>Ultrasound guided Stellate ganglion block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain</description>
    </arm_group>
    <arm_group>
      <arm_group_label>unilateral cervical epidural</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient is placed in prone position, with stabilization of the forehead on a padded support</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ultrasound guided Stellate ganglion block</intervention_name>
      <description>Under visualization with ultrasound, a 22-gauge, 5-cm needle inserted perpendicular to the skin to rest anteriorly to the precervical fascia. 6 mL lidocaine 0.125% and 8 mg dexamethasone in a total volume of 8 mL is used. After injection of a 0.5-mL test dose to exclude intravascular positioning, the remainder of the appropriate dose was administered. The patient will be encouraged to lie flat for 3 minutes after the injection and then to sit up.</description>
      <arm_group_label>Ultrasound guided Stellate ganglion block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>unilateral cervical epidural</intervention_name>
      <description>Aseptic betadine skin preparation will be performed and sterile drapes will be applied. Local anesthetic infiltration of the skin at C7-T1 interspace will be done using 2-3 mL of lidocaine 2% with guidance of the C-arm an 18-gauge. Tuohy needle will be inserted at C7-T1 interspace and directed towards either right or left epidural recess according to the site of the operation. Identification of entering the epidural space will be confirmed by hanging drop technique. The position of the needle is the confirmed by injection of 1 mL of non-ionized diluted dye (omnipause 300) to confirm unilateral spread of the dye. After that, a test dose was administrated, consisting of 2 mL of 2% lidocaine with 1:200,000 epinephrine.</description>
      <arm_group_label>unilateral cervical epidural</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged more than 21 years old of both sexes with American Society of&#xD;
               Anesthesiologists I and II&#xD;
  &#xD;
            2. Upper limb trauma patients with pain disproportionate to the degree of tissue injury&#xD;
               and persists beyond the normal expected time for tissue healing&#xD;
  &#xD;
            3. Patients diagnosed as (Complex Regional Pain Syndrome ) based on Budapest criteria&#xD;
               There should be at least one symptom or sign in three of the four previous categories&#xD;
               that can not be explained by other diagnosis.&#xD;
  &#xD;
            4. The average daily pain intensity required on Numerical Rating Scale is 7 or more for&#xD;
               at least 3 months despite of standard therapy which includes: (pharmacologic therapy&#xD;
               Non-steroidal anti-inflammatory drugs, Antiepileptic drugs(AEDs), antidepressants), as&#xD;
               well as physical therapy and psychiatric care.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  Patients with unstable psychological or psychiatric conditions, including: untreated&#xD;
               bipolar disorder, post-traumatic stress disorder, major depression, severe personality&#xD;
               disorder and psychotic illness&#xD;
  &#xD;
            -  Patients have recently undergone major interventional pain procedures, such as nerve&#xD;
               blocks or implantable therapies.&#xD;
  &#xD;
            -  Patients with known drug dependency or substance use disorder specifically related to&#xD;
               ketamine or other psycho-stimulant drugs&#xD;
  &#xD;
            -  Patients with previous severe reactions, contraindication or allergy to ketamine&#xD;
  &#xD;
            -  Patients with hepatic or renal impairment&#xD;
  &#xD;
            -  Active infection at the injection site&#xD;
  &#xD;
            -  Known allergies to medications&#xD;
  &#xD;
            -  Previous neck surgeries&#xD;
  &#xD;
            -  Raynaud's disease or Raynaud's phenomena&#xD;
  &#xD;
            -  Coagulopathy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aya H Hegazy</last_name>
        <phone>+20 101 192 3265</phone>
        <email>Ahhegazy1993@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Aya Hassan Moustafa Hegazy</investigator_full_name>
      <investigator_title>Assistant lecturer</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_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>The data will be available upon a reasonable request from the corresponding author</ipd_time_frame>
      <ipd_access_criteria>after the end of study for one year</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/NCT05970146
  org study id: 36264MD58/3/23
  nct id: NCT05970146
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate the efficacy of two regimens of management in relieving chronic refractory pain in
        patients with upper limb complex regional pain syndrome after orthopedic trauma
  Ideal therapy for Complex Regional Pain Syndrome is multimodal with the use of physical
        therapy, psychotherapy, and pharmacologic therapy to complement interventional procedures.
        Within pharmacotherapy, drugs most often utilized include non steroidal anti-inflammatory
        drugs (NSAIDs), gamma-aminobutyric acid receptor agonists (i.e., gabapentin, pregabalin), and
        N-methyl-D-aspartate (NMDA) receptor antagonists (i.e., Ketamine).
  
        In complex Regional Pain Syndrome treatment, stellate ganglion block (SGB) is a
        well-established method of nerve blockade of the sympathetic ganglia in the lower cervical
        and upper thoracic region.
  
        Epidural block have differential block as sensory, motor, and sympathetic. Nerve functions
        are blunt at different rates and to different degrees. Sensory block occurs with a lower
        concentration of Local anathesia and develops faster than motor block with coexisting
        sympathectomy.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The percent on satisfactory relief of pain
  time frame: 6 month post injection
  description: Numerical rating scales (NRS) is an 11-Point Scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable.
  NRS was measured before, immediately after injection, 3 and 6 month post injection.
  measure: The degree of chronic pain using Brief Pain Inventory
  time frame: 6 month post injection
  description: Brief Pain Inventory short form (BPI-SF) questionnaire. It is a nine item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, normal work, relations with other persons, sleep, and enjoyment of life on a 10 Point Scale
  BPI-SF was measured before, immediately after injection, 3 and 6 month post injection
  measure: The incidence of complication
  time frame: 2 hours post-intervention
  description: complications as hypotension, headache and neck pain
  arm group label: Ultrasound guided Stellate ganglion block
  arm group type: Experimental
  description: The procedure is going to be the anterior paratracheal approach on the cervical sympathetic chain
  arm group label: unilateral cervical epidural
  arm group type: Experimental
  description: The patient is placed in prone position, with stabilization of the forehead on a padded support
  intervention type: Drug
  intervention name: Ultrasound guided Stellate ganglion block
  description: Under visualization with ultrasound, a 22-gauge, 5-cm needle inserted perpendicular to the skin to rest anteriorly to the precervical fascia. 6 mL lidocaine 0.125% and 8 mg dexamethasone in a total volume of 8 mL is used. After injection of a 0.5-mL test dose to exclude intravascular positioning, the remainder of the appropriate dose was administered. The patient will be encouraged to lie flat for 3 minutes after the injection and then to sit up.
  arm group label: Ultrasound guided Stellate ganglion block
  intervention type: Drug
  intervention name: unilateral cervical epidural
  description: Aseptic betadine skin preparation will be performed and sterile drapes will be applied. Local anesthetic infiltration of the skin at C7-T1 interspace will be done using 2-3 mL of lidocaine 2% with guidance of the C-arm an 18-gauge. Tuohy needle will be inserted at C7-T1 interspace and directed towards either right or left epidural recess according to the site of the operation. Identification of entering the epidural space will be confirmed by hanging drop technique. The position of the needle is the confirmed by injection of 1 mL of non-ionized diluted dye (omnipause 300) to confirm unilateral spread of the dye. After that, a test dose was administrated, consisting of 2 mL of 2% lidocaine with 1:200,000 epinephrine.
  arm group label: unilateral cervical epidural
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Aya Hassan Moustafa Hegazy
  investigator title: Assistant lecturer
  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 info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: The data will be available upon a reasonable request from the corresponding author
  ipd access criteria: after the end of study for one year