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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008899

Collaborator

(none)

Enrollment

Arms

11.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perineal Pain	Procedure: US assisted caudal epidural pulsed radiofrequency	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Aug 25, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ultrasound (US) assisted caudal epidural pulsed radiofrequency	Procedure: US assisted caudal epidural pulsed radiofrequency patients will receive US assisted caudal epidural pulsed radiofrequency and followed up to 8 weeks
No Intervention: conventional medical treatment

Arm

Intervention/Treatment

Active Comparator: ultrasound (US) assisted caudal epidural pulsed radiofrequency

Procedure: US assisted caudal epidural pulsed radiofrequency

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

No Intervention: conventional medical treatment

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Adel El sherif,MD, associate professor of anesthesia, intensive care and pain management, Assiut University

ClinicalTrials.gov Identifier:

NCT06008899

Other Study ID Numbers:

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 24, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 24, 2023