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S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04782206
Collaborator
(none)
20
Enrollment
2
Arms
13.5
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: superior hypogastric plexus block
  • Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blinded
Primary Purpose:
Treatment
Official Title:
the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study
Anticipated Study Start Date :
Mar 15, 2021
Anticipated Primary Completion Date :
Mar 15, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pain intensity [from 30 min. after procedure to 2 months after it]

    Visual Analogue Scale post-procedure

Secondary Outcome Measures

  1. 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

  2. procedure time [during the block procedure]

    The time required to perform the block

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmad Mohammad Abd El-Rahman, Assisstant Professor of Anesthesia, ICU, and Pain management, Assiut University
ClinicalTrials.gov Identifier:
NCT04782206
Other Study ID Numbers:
  • 366
First Posted:
Mar 4, 2021
Last Update Posted:
Mar 4, 2021
Last Verified:
Mar 1, 2021
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
Keywords provided by Ahmad Mohammad Abd El-Rahman, Assisstant Professor of Anesthesia, ICU, and Pain management, Assiut University
pelvic cancer pain
superior hypogastric plexus block
pulsed radiofrequency
Additional relevant MeSH terms:
Chronic Pain

Study Results

No Results Posted as of Mar 4, 2021