Clinical trial · Interventional
Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain
The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interactable Malignant Perineal Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) | Drug | — | UNRESOLVED |
| Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy | Procedure | — | UNRESOLVED |
| Thermal RF lesioning is done using Bailys RF generator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Thermal Radiofrequency group
- description
- Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
- interventionNames
- Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy
- Device: Thermal RF lesioning is done using Bailys RF generator
- type
- ACTIVE_COMPARATOR
- label
- phenol group
- description
- Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
- interventionNames
- Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available