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
About this trial
This is an interventional treatment trial for Chronic Pelvic Cancer Pain
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
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
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
Learn more about this trial
Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain
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