S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

Not Applicable

• Conditions: Pain Cancer; Pain, Chronic
• Interventions: Procedure: superior hypogastric plexus block; Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block

• Registration Number: NCT04782206
• Lead Sponsor: Assiut University

Brief Summary

The investigators hypothesis that adding pulsed radiofrequency neuromodulation at S3 nerve root to superior hypogastric plexus chemical neurolysis improves analgesia in patients with chronic pelvic cancer pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-03
• Last Update Submitted: 2021-03-03
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04
• Study Start: 2021-03-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• pelvic cancer patients
• with pelvic pain not responding to oral analgesic medications
• side effects of oral analgesic medications

Exclusion Criteria

• patients with metastatic cancer disease
• patients with significantly impaired organ functions
• patients with bleeding diathesis
• patients with mental disabilities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	superior hypogastric plexus block	superior hypogastric plexus block
group 2	pulsed radiofrequency at S3 root plus superior hypogastric plexus block	pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block

Primary Outcome Measures

Name	Time	Method
pain intensity	from 30 min. after procedure to 2 months after it	Visual Analogue Scale post-procedure

Secondary Outcome Measures

Name	Time	Method
Total oral analgesic consumption	in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it	total MST consumption
procedure time	during the block procedure	The time required to perform the block
complications	during the block procedure and within the first 24 hours after the block	including transient paresthesia, rectal puncture, vascular penetration of one of the pelvic vessels, hematoma, infection, dural puncture, bowel/bladder dysfunction, pain on injection, hypotension from the sympathetic block or any other complication