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NCT06008899 Clinical Trial

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

Perineal Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06008899
Other study ID # 629
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 25, 2023
Est. completion date August 2024

Study information
Verified date June 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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