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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: Ganglion Impar Neurolysis; Procedure: Bilateral S2, S3 and S4 Pulsed radiofrequency

• Registration Number: NCT05591430
• Lead Sponsor: National Cancer Institute, Egypt

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2022-10-28
• Primary Completion: 2024-05-25
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ganglion Impar Neurolysis	Ganglion Impar Neurolysis	Block of ganglion impar using neurolytic
Bilateral S2, S3 and S4 Pulsed radiofrequency	Bilateral S2, S3 and S4 Pulsed radiofrequency	Pulsed radiofrequency of S2-S4

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	2 hours	the score of visual analogue scale score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt