S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

March 3, 2021 updated by: Ahmad Mohammad Abd El-Rahman, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: from 30 min. after procedure to 2 months after it
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
Time Frame: 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
during the block procedure and within the first 24 hours after the block
procedure time
Time Frame: during the block procedure
The time required to perform the block
during the block procedure
Total oral analgesic consumption
Time Frame: in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it
total MST consumption
in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2021

Primary Completion (Anticipated)

March 15, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 366

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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