Back to resultsS3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
Primary Purpose
Pain Cancer, Pain, Chronic
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior hypogastric plexus block
pulsed radiofrequency at S3 root plus superior hypogastric plexus block
Sponsored by
About this trial
This is an interventional treatment trial for Pain Cancer focused on measuring pelvic cancer pain, superior hypogastric plexus block, pulsed radiofrequency
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group 1
group 2
Arm Description
superior hypogastric plexus block
pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block
Outcomes
Primary Outcome Measures
pain intensity
Visual Analogue Scale post-procedure
Secondary Outcome Measures
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
procedure time
The time required to perform the block
Total oral analgesic consumption
total MST consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04782206
Brief Title
S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
Official Title
the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2021 (Anticipated)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Cancer, Pain, Chronic
Keywords
pelvic cancer pain, superior hypogastric plexus block, pulsed radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blinded
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Active Comparator
Arm Description
superior hypogastric plexus block
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block
Intervention Type
Procedure
Intervention Name(s)
superior hypogastric plexus block
Intervention Description
superior hypogastric plexus chemical neurolysis
Intervention Type
Procedure
Intervention Name(s)
pulsed radiofrequency at S3 root plus superior hypogastric plexus block
Intervention Description
pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis
Primary Outcome Measure Information:
Title
pain intensity
Description
Visual Analogue Scale post-procedure
Time Frame
from 30 min. after procedure to 2 months after it
Secondary Outcome Measure Information:
Title
complications
Description
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
Time Frame
during the block procedure and within the first 24 hours after the block
Title
procedure time
Description
The time required to perform the block
Time Frame
during the block procedure
Title
Total oral analgesic consumption
Description
total MST consumption
Time Frame
in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
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