Interactable Malignant Perineal Pain
Conditions
Keywords
neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency
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.
Interventions
PROCEDUREThermal 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.
DRUGhyperbaric 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.
DEVICEThermal RF lesioning is done using Bailys RF generator
Sponsors
National Cancer Institute (NCI)
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
assessment will be done by junior stuff who is blind to the technique of intervention
Intervention model description
randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VAS | baseline, 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. |
| Functional improvement | baseline, 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 dose of daily drug consuption | base line, one month, 3 months | drug (opioid, pregabalin & amitryptiline) consumption (mg/day) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ODI | baseline, 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. |
| PGIC | baseline, one month and 3 months | Patient satisfaction (PGIC): Patient Global Impression of Changes |
Outcome results
None listed