NCT06008899

Brief Summary

Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and intervention related side effects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

August 17, 2023

Last Update Submit

August 6, 2024

Conditions

Perineal Pain

Outcome Measures

Primary Outcomes (1)

  • visual analog scale (VAS) score 4 weeks post-intervention

    Our primary goal will be to investigate the analgesic efficacy of ultrasound-assisted caudal epidural PRF stimulation in patients with perineal or anal pain cancer patients using VAS scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks

    8 weeks

Study Arms (2)

ultrasound (US) assisted caudal epidural pulsed radiofrequency

ACTIVE COMPARATOR
Procedure: US assisted caudal epidural pulsed radiofrequency

conventional medical treatment

NO INTERVENTION

Interventions

US assisted caudal epidural pulsed radiofrequencyPROCEDURE

patients will receive US assisted caudal epidural pulsed radiofrequency and followed up to 8 weeks

ultrasound (US) assisted caudal epidural pulsed radiofrequency

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiology physical status of I or III (ASA), of both sex
  • cancer-related anal or perineal pain

You may not qualify if:

  • coagulopathies
  • allergies to the contrast dye
  • patients with moderate or significant cardiac/respiratory disease or hepatic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer instIitute

Asyut, 171516, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of anesthesia, intensive care and pain management

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 24, 2023

Study Start

August 25, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

August 7, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)