Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Cancer-related pain represents a major challenge for both clinicians and patients. This pain can be associated directly with the cancer or with certain treatments administered to the patient. 52.1% of cancer patients suffer from pain and that 62.6% are not satisfied with the current pain treatment. Pain prevalence is high in developing countries due to late diagnosis and major impediments to opioid access
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedStudy Start
First participant enrolled
October 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2020
CompletedJuly 2, 2019
July 1, 2019
8 months
June 15, 2017
July 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Visual analogue score for pain
Points on a scale
2 months
Study Arms (2)
the study group one
EXPERIMENTAL20 patients with superior hypogastric plexus block
the study group two
EXPERIMENTAL20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4
Interventions
pulsed radiofrequency on sacral nerve roots 2,3 and 4
Eligibility Criteria
You may qualify if:
- sympathetically maintained pelvic, perineal pain
- pain is no longer controlled with oral morphine sustained release tablets 30 mg
- excessive sedation or other side effects from oral morphine sustained release tablets 30 mg or amitryptyline tablets 25 mg
- age between 18-70 years
You may not qualify if:
- patient refusal
- patients with coagulopathies
- allergy to constant dyes or phenol
- patients receiving radiation or chemotherapy within 4 weeks of neurolytic block
- patients with major or moderate cardiac/respiratory incapacitating diseases
- liver and renal failure
- patients younger than 18 years and older than 70 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
PMID: 27208713BACKGROUNDHetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.
PMID: 32214294DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- prospective interventional
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle invistigator
Study Record Dates
First Submitted
June 15, 2017
First Posted
July 24, 2017
Study Start
October 20, 2019
Primary Completion
June 20, 2020
Study Completion
December 20, 2020
Last Updated
July 2, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share