Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

Cairo University40 enrolled

Overview

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".

40 selected patients were randomly allocated into 2 groups "20 patients each" 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Interactable Malignant Perineal Pain

Interventions

Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomyPROCEDURE

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)DRUG

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 generatorDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cancer patients with moderate to severe perineal pain (VAS \> 40mm over 100 mm scale). * 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: * Uncorrected coagulopathy. * 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).

Outcomes

Primary Outcomes

Change in VAS

VAS: A 100mm scale, horizontal line with 2 stop ends; the left end means no pain \& the right end means the worst impaginable pain. It is a valid and practical scale for assessing chronic pain and for pain researches.

Time frame: baseline, one month, 3months

Functional improvement

Functional improvement. It is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into four categorie (0-25%) ≈ no or minimal functional improvement, (\> 25% to 50%) ≈ mild improvement, (\>50% to 75%) ≈ moderate improvement, and (\>75% to 100%) ≈ marked improvement

Time frame: baseline, one month, 3 months

Change in dose of daily drug consuption

drug (opioid, pregabalin \& amitryptiline) consumption (mg/day) .

Time frame: base line, one month, 3 months

Secondary Outcomes

ODI

(Oswestry Disability Index): Self-reported questionnaire with 10 sections each with five items designed to assess limitations of various asctivities of daily living.

Time frame: baseline, one month, 3 months

PGIC

Patient satisfaction (PGIC): Patient Global Impression of Changes

Time frame: baseline, one month and 3 months

Data from ClinicalTrials.gov

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