S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain Cancer, Pain, Chronic

Intervention / Treatment
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* Procedure: superior hypogastric plexus block
* Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>superior hypogastric plexus block | Procedure: superior hypogastric plexus block<br>* superior hypogastric plexus chemical neurolysis<br>|
| Active Comparator: group 2<br>pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block | Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block<br>* pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | Visual Analogue Scale post-procedure | from 30 min. after procedure to 2 months after it | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| procedure time | The time required to perform the block | during the block procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic cancer pain, superior hypogastric plexus block, pulsed radiofrequency