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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal Radiofrequency group | Active Comparator | Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy. |
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| phenol group | Active Comparator | Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina N Abbas, MD | National Cancer Institute,Cairo University | Principal Investigator |
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randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
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assessment will be done by junior stuff who is blind to the technique of intervention
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| 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. |
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| Thermal RF lesioning is done using Bailys RF generator | Device |
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Patient satisfaction (PGIC): Patient Global Impression of Changes
| baseline, one month and 3 months |
| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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