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Clinical Trials/NCT06008899
NCT06008899
Recruiting
Not Applicable

Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal and Perineal Pain in Cancer Patients, a Prospective Randomized Clinical Study

Assiut University1 site in 1 country40 target enrollmentAugust 25, 2023
ConditionsPerineal Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perineal Pain
Sponsor
Assiut University
Enrollment
40
Locations
1
Primary Endpoint
visual analog scale (VAS) score 4 weeks post-intervention
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 25, 2023
End Date
January 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Adel El sherif,MD

associate professor of anesthesia, intensive care and pain management

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

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

Study Sites (1)

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