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

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".

Study Overview

• Status: Unknown
• Conditions: Interactable Malignant Perineal Pain
• Intervention / Treatment: Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy; Device: Thermal RF lesioning is done using Bailys RF generator; Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Thermal Radiofrequency group; Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.	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.; Device: Thermal RF lesioning is done using Bailys RF generator
ACTIVE_COMPARATOR: phenol group; Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.	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.; Other Names: 6 % pherol in glycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Patient satisfaction (PGIC): Patient Global Impression of Changes	baseline, one month and 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dina N Abbas, MD, National Cancer Institute,Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ANTICIPATED): May 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: IRB No.201516026.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED