Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neuro... | NCT05591430

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

NCT05591430

Sponsor

National Cancer Institute, Egypt

Status

Completed

Last Update Posted

Jun 24, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Analgesia

Interventions

Ganglion Impar Neurolysis
Bilateral S2, S3 and S4 Pulsed radiofrequency

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2022Actual

Primary Completion Date

May 25, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 19, 2022

First Posted Date

Oct 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2024

Last Update Posted Date

Jun 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Youssef Elsabeeny, Assistant professor of Anesthesia and Pain management, National Cancer Institute, EgyptPrincipal Investigator

Lead Sponsor

National Cancer Institute, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ganglion Impar Neurolysis	Active Comparator	Block of ganglion impar using neurolytic	Procedure: Ganglion Impar Neurolysis
Bilateral S2, S3 and S4 Pulsed radiofrequency	Experimental	Pulsed radiofrequency of S2-S4	Procedure: Bilateral S2, S3 and S4 Pulsed radiofrequency

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ganglion Impar Neurolysis	Procedure	block of Ganglion Impar by neurolytic drug	Ganglion Impar Neurolysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Walaa Y Elsabeeny, MD	Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walaa Y Elsabeeny		Cairo		11796	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided