Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients

NCT ID: NCT05591430

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-28

Study Completion Date

2024-05-30

Brief Summary

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Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.

Detailed Description

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Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Ganglion impar block has been traditionally used for treatment of such perineal pain. Radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ganglion Impar Neurolysis

Block of ganglion impar using neurolytic

Group Type ACTIVE_COMPARATOR

Ganglion Impar Neurolysis

Intervention Type PROCEDURE

block of Ganglion Impar by neurolytic drug

Bilateral S2, S3 and S4 Pulsed radiofrequency

Pulsed radiofrequency of S2-S4

Group Type EXPERIMENTAL

Bilateral S2, S3 and S4 Pulsed radiofrequency

Intervention Type PROCEDURE

Bilateral S2, S3 and S4 Pulsed radiofrequency

Interventions

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Ganglion Impar Neurolysis

block of Ganglion Impar by neurolytic drug

Intervention Type PROCEDURE

Bilateral S2, S3 and S4 Pulsed radiofrequency

Bilateral S2, S3 and S4 Pulsed radiofrequency

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients aged 18-75 years
* ASA II-III with perianal and perineal pain related to cancer

Exclusion Criteria

* patient refusal
* coagulation defects
* abnormal kidney or liver functions
* local infection at site of injection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Assistant professor of Anesthesia and Pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2207-50108

Identifier Type: -

Identifier Source: org_study_id

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