S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

NCT ID: NCT04782206

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-05-01

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.

Detailed Description

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Conditions

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Pain Cancer Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
double-blinded

Study Groups

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group 1

superior hypogastric plexus block

Group Type ACTIVE_COMPARATOR

superior hypogastric plexus block

Intervention Type PROCEDURE

superior hypogastric plexus chemical neurolysis

group 2

pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block

Group Type ACTIVE_COMPARATOR

pulsed radiofrequency at S3 root plus superior hypogastric plexus block

Intervention Type PROCEDURE

pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis

Interventions

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superior hypogastric plexus block

superior hypogastric plexus chemical neurolysis

Intervention Type PROCEDURE

pulsed radiofrequency at S3 root plus superior hypogastric plexus block

pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mohammad Abd El-Rahman

Assisstant Professor of Anesthesia, ICU, and Pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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366

Identifier Type: -

Identifier Source: org_study_id

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