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Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain

Primary Purpose

Chronic Pelvic Cancer Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior hypogastric plexus block
pulsed radiofrequency
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Cancer Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • sympathetically maintained pelvic, perineal pain
  • pain is no longer controlled with oral morphine sustained release tablets 30 mg
  • excessive sedation or other side effects from oral morphine sustained release tablets 30 mg or amitryptyline tablets 25 mg
  • age between 18-70 years

Exclusion Criteria:

  • patient refusal
  • patients with coagulopathies
  • allergy to constant dyes or phenol
  • patients receiving radiation or chemotherapy within 4 weeks of neurolytic block
  • patients with major or moderate cardiac/respiratory incapacitating diseases
  • liver and renal failure
  • patients younger than 18 years and older than 70 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    the study group one

    the study group two

    Arm Description

    20 patients with superior hypogastric plexus block

    20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4

    Outcomes

    Primary Outcome Measures

    Visual analogue score for pain
    Points on a scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    July 1, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03228316
    Brief Title
    Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain
    Official Title
    Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2019 (Anticipated)
    Primary Completion Date
    June 20, 2020 (Anticipated)
    Study Completion Date
    December 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pelvic Cancer Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    prospective interventional
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the study group one
    Arm Type
    Experimental
    Arm Description
    20 patients with superior hypogastric plexus block
    Arm Title
    the study group two
    Arm Type
    Experimental
    Arm 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(s)
    superior hypogastric plexus block
    Intervention Description
    nerve plexus block
    Intervention Type
    Radiation
    Intervention Name(s)
    pulsed radiofrequency
    Intervention Description
    pulsed radiofrequency on sacral nerve roots 2,3 and 4
    Primary Outcome Measure Information:
    Title
    Visual analogue score for pain
    Description
    Points on a scale
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: sympathetically maintained pelvic, perineal pain pain is no longer controlled with oral morphine sustained release tablets 30 mg excessive sedation or other side effects from oral morphine sustained release tablets 30 mg or amitryptyline tablets 25 mg age between 18-70 years Exclusion Criteria: patient refusal patients with coagulopathies allergy to constant dyes or phenol patients receiving radiation or chemotherapy within 4 weeks of neurolytic block patients with major or moderate cardiac/respiratory incapacitating diseases liver and renal failure patients younger than 18 years and older than 70 years
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma Ahmed Abdel Aal, professor
    Phone
    01113221317
    Ext
    002
    Email
    Fatmaabdelal23@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashraf Amin, professor
    Phone
    01153131503
    Ext
    002
    Email
    ashrafkena@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27208713
    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.
    Results Reference
    background
    PubMed Identifier
    32214294
    Citation
    Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    http://www.ncbi.nlm.nih.gov/pubmed/27208713

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    Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain

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