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Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

Phase 2
Conditions
Interactable Malignant Perineal Pain
Interventions
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
Registration Number
NCT03084575
Lead Sponsor
Cairo University
Brief 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".

Detailed Description

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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).
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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Thermal Radiofrequency groupThermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomyGroup 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Thermal Radiofrequency groupThermal RF lesioning is done using Bailys RF generatorGroup 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
phenol grouphyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
Primary Outcome Measures
NameTimeMethod
Change in dose of daily drug consuptionbase line, one month, 3 months

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

Functional improvementbaseline, one month, 3 months

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

Change in VASbaseline, one month, 3months

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.

Secondary Outcome Measures
NameTimeMethod
ODIbaseline, one month, 3 months

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

PGICbaseline, one month and 3 months

Patient satisfaction (PGIC): Patient Global Impression of Changes

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