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Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

NCT03084575 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-21

No results posted yet for this study

Summary

The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy.

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".

Conditions

  • Interactable Malignant Perineal Pain

Interventions

PROCEDURE

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.

DRUG

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.

DEVICE

Thermal RF lesioning is done using Bailys RF generator

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cairo University

    lead OTHER

Principal Investigators

  • Dina N Abbas, MD · National Cancer Institute,Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03084575 on ClinicalTrials.gov