NCT05591430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

October 19, 2022

Last Update Submit

June 20, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Ganglion Impar NeurolysisPROCEDURE

block of Ganglion Impar by neurolytic drug

Ganglion Impar Neurolysis
Bilateral S2, S3 and S4 Pulsed radiofrequencyPROCEDURE

Bilateral S2, S3 and S4 Pulsed radiofrequency

Bilateral S2, S3 and S4 Pulsed radiofrequency

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 18-75 years
  • ASA II-III with perianal and perineal pain related to cancer

You may not qualify if:

  • patient refusal
  • coagulation defects
  • abnormal kidney or liver functions
  • local infection at site of injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Walaa Y Elsabeeny, MD

    Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Pain management

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

October 28, 2022

Primary Completion

May 25, 2024

Study Completion

May 30, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

EG(1)