S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

Pain, Chronic Clinical Trial

Official title:

the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04782206
• Other study ID #: 366
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain Cancer
• Pain, Chronic

Intervention

Procedure:
• superior hypogastric plexus block
superior hypogastric plexus chemical neurolysis
• pulsed radiofrequency at S3 root plus superior hypogastric plexus block
pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity	Visual Analogue Scale post-procedure	from 30 min. after procedure to 2 months after it
Secondary	complications	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	during the block procedure and within the first 24 hours after the block
Secondary	procedure time	The time required to perform the block	during the block procedure
Secondary	Total oral analgesic consumption	total MST consumption	in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it