Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain

Interactable Malignant Perineal Pain Clinical Trial

Official title:

The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03084575
• Other study ID #: IRB No.201516026.2
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: March 9, 2017
• Last updated: March 20, 2017
• Start date: February 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Interactable Malignant Perineal Pain

Intervention

Procedure:
• Thermal 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.

Drug:
• hyperbaric 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.

Device:
• Thermal RF lesioning is done using Bailys RF generator

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in dose of daily drug consuption	drug (opioid, pregabalin & amitryptiline) consumption (mg/day) .	base line, one month, 3 months
Secondary	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
Secondary	PGIC	Patient satisfaction (PGIC): Patient Global Impression of Changes	baseline, one month and 3 months