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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Analgesia
• Ganglion Cysts

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