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

Primary Purpose

Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ganglion Impar Neurolysis
Bilateral S2, S3 and S4 Pulsed radiofrequency
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Walaa Y ElsabeenyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ganglion Impar Neurolysis

Bilateral S2, S3 and S4 Pulsed radiofrequency

Arm Description

Block of ganglion impar using neurolytic

Pulsed radiofrequency of S2-S4

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 19, 2022
Last Updated
January 8, 2023
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05591430
Brief Title
Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ganglion Impar Neurolysis
Arm Type
Active Comparator
Arm Description
Block of ganglion impar using neurolytic
Arm Title
Bilateral S2, S3 and S4 Pulsed radiofrequency
Arm Type
Experimental
Arm Description
Pulsed radiofrequency of S2-S4
Intervention Type
Procedure
Intervention Name(s)
Ganglion Impar Neurolysis
Intervention Description
block of Ganglion Impar by neurolytic drug
Intervention Type
Procedure
Intervention Name(s)
Bilateral S2, S3 and S4 Pulsed radiofrequency
Intervention Description
Bilateral S2, S3 and S4 Pulsed radiofrequency
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
the score of visual analogue scale score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
Time Frame
Two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa Y Elsabeeny, MD
Phone
01007798466
Ext
+2
Email
walaa.elsabeeny@nci.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Taher S Thabet, MD
Phone
01225358877
Ext
+2
Email
dr.taherthabet@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walaa Y Elsabeeny, MD
Organizational Affiliation
Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walaa Y Elsabeeny
City
Cairo
ZIP/Postal Code
11796
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa Y Elsabeeny, MD
Phone
+201007798466
Ext
+2
Email
walaa.elsabeeny@nci.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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