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Trial record 59 of 580 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

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ClinicalTrials.gov Identifier: NCT03228316
Recruitment Status : Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
marina emeel helal, Assiut University

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

Condition or disease Intervention/treatment Phase
Chronic Pelvic Cancer Pain Procedure: superior hypogastric plexus block Radiation: pulsed radiofrequency Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: prospective interventional
Primary Purpose: Treatment
Official Title: Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : December 20, 2020

Arm Intervention/treatment
Experimental: the study group one
20 patients with superior hypogastric plexus block
Procedure: superior hypogastric plexus block
nerve plexus block

Experimental: the study group two
20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4
Procedure: superior hypogastric plexus block
nerve plexus block

Radiation: pulsed radiofrequency
pulsed radiofrequency on sacral nerve roots 2,3 and 4




Primary Outcome Measures :
  1. Visual analogue score for pain [ Time Frame: 2 months ]
    Points on a scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228316


Contacts
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Contact: Fatma Ahmed Abdel Aal, professor 01113221317 ext 002 Fatmaabdelal23@yahoo.com
Contact: Ashraf Amin, professor 01153131503 ext 002 ashrafkena@yahoo.com

Sponsors and Collaborators
Assiut University

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: marina emeel helal, principle invistigator, Assiut University
ClinicalTrials.gov Identifier: NCT03228316     History of Changes
Other Study ID Numbers: MEHG
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cancer Pain
Pelvic Neoplasms
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms by Site
Neoplasms