<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/NCT03228316</url>
  </required_header>
  <id_info>
    <org_study_id>MEHG</org_study_id>
    <nct_id>NCT03228316</nct_id>
  </id_info>
  <brief_title>Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain</brief_title>
  <official_title>Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer-related pain represents a major challenge for both clinicians and patients. This pain&#xD;
      can be associated directly with the cancer or with certain treatments administered to the&#xD;
      patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the&#xD;
      current pain treatment. Pain prevalence is high in developing countries due to late diagnosis&#xD;
      and major impediments to opioid access&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix,&#xD;
      endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of&#xD;
      the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate&#xD;
      that the prevalence of pain in patients with pelvic cancer is &gt;50%, and can be upwards of 60%&#xD;
      to 70% in patients with advanced or metastatic disease . Cancer patients with extension of&#xD;
      tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only&#xD;
      fail to provide relief, but may cause excessive sedation and other side effects. More&#xD;
      invasive approaches may thus be needed to control pain and improve the quality of life. Since&#xD;
      pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous&#xD;
      chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric&#xD;
      plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk&#xD;
      between these levels. It is an extension of the aortic plexus below the aortic bifurcation,&#xD;
      and contains almost exclusively sympathetic ﬁbers and visceral afferents . Afferent pain&#xD;
      ﬁbers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami;&#xD;
      thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer&#xD;
      pain. Several studies examined the use of superior hypogastric plexus block in the treatment&#xD;
      of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither&#xD;
      the follow-up period nor the proportion with a successful prognostic block were noted.&#xD;
      Radiofrequency utilizes a high-frequency alternating current that is passed from the needle&#xD;
      electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to&#xD;
      the accuracy of lesions produced by radiofrequency ablation, there has been growing interest&#xD;
      in the use of this technique for neurolysis of nerves as it offers the potential of accurate&#xD;
      nerve destruction ablation, with a predictable and controlled ablative lesion. Another&#xD;
      advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and&#xD;
      phenol, which may take up to 1 week or 10 days to achieve neurolysis .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 20, 2019</start_date>
  <completion_date type="Anticipated">December 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>prospective interventional</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue score for pain</measure>
    <time_frame>2 months</time_frame>
    <description>Points on a scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chronic Pelvic Cancer Pain</condition>
  <arm_group>
    <arm_group_label>the study group one</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients with superior hypogastric plexus block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the study group two</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>superior hypogastric plexus block</intervention_name>
    <description>nerve plexus block</description>
    <arm_group_label>the study group one</arm_group_label>
    <arm_group_label>the study group two</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>pulsed radiofrequency</intervention_name>
    <description>pulsed radiofrequency on sacral nerve roots 2,3 and 4</description>
    <arm_group_label>the study group two</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  sympathetically maintained pelvic, perineal pain&#xD;
&#xD;
          -  pain is no longer controlled with oral morphine sustained release tablets 30 mg&#xD;
&#xD;
          -  excessive sedation or other side effects from oral morphine sustained release tablets&#xD;
             30 mg or amitryptyline tablets 25 mg&#xD;
&#xD;
          -  age between 18-70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  patients with coagulopathies&#xD;
&#xD;
          -  allergy to constant dyes or phenol&#xD;
&#xD;
          -  patients receiving radiation or chemotherapy within 4 weeks of neurolytic block&#xD;
&#xD;
          -  patients with major or moderate cardiac/respiratory incapacitating diseases&#xD;
&#xD;
          -  liver and renal failure&#xD;
&#xD;
          -  patients younger than 18 years and older than 70 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fatma Ahmed Abdel Aal, professor</last_name>
    <phone>01113221317</phone>
    <phone_ext>002</phone_ext>
    <email>Fatmaabdelal23@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashraf Amin, professor</last_name>
    <phone>01153131503</phone>
    <phone_ext>002</phone_ext>
    <email>ashrafkena@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.</citation>
    <PMID>27208713</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>June 15, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>marina emeel helal</investigator_full_name>
    <investigator_title>principle invistigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Neoplasms</mesh_term>
    <mesh_term>Cancer Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/27208713</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228316
org study id: MEHG
nct id: NCT03228316
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cancer-related pain represents a major challenge for both clinicians and patients. This pain
      can be associated directly with the cancer or with certain treatments administered to the
      patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the
      current pain treatment. Pain prevalence is high in developing countries due to late diagnosis
      and major impediments to opioid access
pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix,
      endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of
      the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate
      that the prevalence of pain in patients with pelvic cancer is >50%, and can be upwards of 60%
      to 70% in patients with advanced or metastatic disease . Cancer patients with extension of
      tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only
      fail to provide relief, but may cause excessive sedation and other side effects. More
      invasive approaches may thus be needed to control pain and improve the quality of life. Since
      pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous
      chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric
      plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk
      between these levels. It is an extension of the aortic plexus below the aortic bifurcation,
      and contains almost exclusively sympathetic ﬁbers and visceral afferents . Afferent pain
      ﬁbers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami;
      thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer
      pain. Several studies examined the use of superior hypogastric plexus block in the treatment
      of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither
      the follow-up period nor the proportion with a successful prognostic block were noted.
      Radiofrequency utilizes a high-frequency alternating current that is passed from the needle
      electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to
      the accuracy of lesions produced by radiofrequency ablation, there has been growing interest
      in the use of this technique for neurolysis of nerves as it offers the potential of accurate
      nerve destruction ablation, with a predictable and controlled ablative lesion. Another
      advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and
      phenol, which may take up to 1 week or 10 days to achieve neurolysis .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
masking description: prospective interventional
measure: Visual analogue score for pain
time frame: 2 months
description: Points on a scale
arm group label: the study group one
arm group type: Experimental
description: 20 patients with superior hypogastric plexus block
arm group label: the study group two
arm group type: Experimental
description: 20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4
intervention type: Procedure
intervention name: superior hypogastric plexus block
description: nerve plexus block
arm group label: the study group one
arm group label: the study group two
intervention type: Radiation
intervention name: pulsed radiofrequency
description: pulsed radiofrequency on sacral nerve roots 2,3 and 4
arm group label: the study group two
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fatma Ahmed Abdel Aal, professor
phone: 01113221317
phone ext: 002
email: Fatmaabdelal23@yahoo.com
last name: Ashraf Amin, professor
phone: 01153131503
phone ext: 002
email: ashrafkena@yahoo.com
citation: Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
PMID: 27208713
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: marina emeel helal
investigator title: principle invistigator
mesh term: Pelvic Neoplasms
mesh term: Cancer Pain
sharing ipd: No
study doc: 