Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Interactable Malignant Perineal Pain

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03084575

IRB No.201516026.2

Details and patient eligibility

About

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".

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Thermal Radiofrequency group

Active Comparator group

Description:

Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.

Treatment:

Device: Thermal RF lesioning is done using Bailys RF generator

Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy

phenol group

Active Comparator group

Description:

Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.

Treatment:

Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)