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Status unknownNCT06008899Updated Aug 7, 2024

Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal Pain in Cancer Patients,

An interventional study of US assisted caudal epidural pulsed radiofrequency in Perineal Pain, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Assiut University · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Perineal Pain
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • coagulopathies
  • allergies to the contrast dye
  • patients with moderate or significant cardiac/respiratory disease or hepatic
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    ultrasound (US) assisted caudal epidural pulsed radiofrequency

    Procedure: US assisted caudal epidural pulsed radiofrequency

  • No intervention
    conventional medical treatment

Interventions

  • ProcedureUS assisted caudal epidural pulsed radiofrequency

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

06

What researchers measure

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

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • South Egypt Cancer instIitute
    Asyut, 171516, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Dec 2024, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2023
First posted
Aug 24, 2023
StartActual
Aug 25, 2023
Primary completionEst.
Dec 2024
CompletionEst.
Jan 2025
Last update
Aug 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06008899
Lead sponsor
Assiut University
Responsible party
Fatma Adel El sherif,MD (associate professor of anesthesia, intensive care and pain management, Assiut University) — Principal investigator
First posted
Aug 24, 2023
Start date
Aug 25, 2023
Primary completion
Dec 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Aug 7, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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