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Completed

NCT Number: NCT05591430

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

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Walaa Y Elsabeeny

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ganglion Impar Neurolysis

Procedure

block of Ganglion Impar by neurolytic drug

Bilateral S2, S3 and S4 Pulsed radiofrequency

Procedure

Bilateral S2, S3 and S4 Pulsed radiofrequency

Primary outcomes

  1. Visual analogue scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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