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NCT05591430 Clinical Trial

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

Analgesia Clinical Trial

Official title:
Bilateral Pulsed Radiofrequency of Dorsal Root Ganglia of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05591430
Other study ID # AP2207-50108
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2022
Est. completion date November 25, 2024

Study information
Verified date May 2024
Source National Cancer Institute, Egypt
Contact Walaa Y Elsabeeny, MD
Phone 01007798466
Email walaa.elsabeeny@nci.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date November 25, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ganglion Impar Neurolysis
block of Ganglion Impar by neurolytic drug
• Bilateral S2, S3 and S4 Pulsed radiofrequency
Bilateral S2, S3 and S4 Pulsed radiofrequency

Locations
Country Name City State
Egypt Walaa Y Elsabeeny Cairo

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual analogue scale the score of visual analogue scale score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain 2 hours
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