Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain
NCT ID: NCT03084575
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2016-02-29
2017-06-30
Brief Summary
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Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to chemical saddle rhizotomy".
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Detailed Description
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Group 1 "RF group": in which patients underwent thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Group 2 "phenol group": in which patients underwent hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Thermal Radiofrequency group
Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy
Thermal RF lesioning is done using Bailys RF generator. TRF parameters are 80 C, 120 seconds the TRF lesion is repeated after 180 rotation of the needle tip again after sensory and motor pre-stimulation.
Thermal RF lesioning is done using Bailys RF generator
phenol group
Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)
L5-S1 intrathecal injection of 0.5-1 ml of 6 % pherol in glycerin. The patient is seated in the sitting position with 30-45o leaning backwards to make the posterior sensory roots lowermost.
Interventions
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Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy
Thermal RF lesioning is done using Bailys RF generator. TRF parameters are 80 C, 120 seconds the TRF lesion is repeated after 180 rotation of the needle tip again after sensory and motor pre-stimulation.
hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)
L5-S1 intrathecal injection of 0.5-1 ml of 6 % pherol in glycerin. The patient is seated in the sitting position with 30-45o leaning backwards to make the posterior sensory roots lowermost.
Thermal RF lesioning is done using Bailys RF generator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intractable pain not responding to adequate tolerated opioid therapy + adjuvant therapy after reasonable period of time for at least 4 weeks (Rad and Kallmes, 2011).
* Limited life expectancy \< 12 months (Slatakin etal 2003).
* Patients are continent to urine and stool (no stomas).
Exclusion Criteria
* Local or systemic sepsis.
* Known allergy to the used medications.
* Distorted local anatomy e.g. by advanced local neoplastic growth rendering the procedure technically difficult or hazardous.
* Sign of increased intracranial tension (Mintzer and Devarajan, 2012).
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Cairo University
OTHER
Responsible Party
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Dina Nabil Abbas
Assistant professor of anethesia and pain management
Principal Investigators
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Dina N Abbas, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute,Cairo University
Other Identifiers
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IRB No.201516026.2
Identifier Type: -
Identifier Source: org_study_id
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