Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study

Conditions
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Interactable Malignant Perineal Pain

Intervention / Treatment
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* Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy
* Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)
* Device: Thermal RF lesioning is done using Bailys RF generator


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thermal Radiofrequency group<br>Group 1 RF group: in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy. | Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy<br>* 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.<br>Device: Thermal RF lesioning is done using Bailys RF generator<br> <br> |
| Active Comparator: phenol group<br>Group 2 phenol group: in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin. | Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)<br>* 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.<br>* Other names: 6 % pherol in glycerin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | baseline, one month, 3 months | 
| Change in dose of daily drug consuption | drug (opioid, pregabalin & amitryptiline) consumption (mg/day) . | base line, one month, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ODI | (Oswestry Disability Index): Self-reported questionnaire with 10 sections each with five items designed to assess limitations of various asctivities of daily living. | baseline, one month, 3 months | 
| PGIC | Patient satisfaction (PGIC): Patient Global Impression of Changes | baseline, one month and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency