Pain CancerNCT04782206
S3 Root Pulsed Radiofrequency Added to Superior Hypogstric Plexus Block
A study testing superior hypogastric plexus block and pulsed radiofrequency at S3 root plus superior hypogastric plexus block in people with Pain Cancer and Pain, Chronic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Cancer, Pain, Chronic
- What is being tested?
- superior hypogastric plexus block and pulsed radiofrequency at S3 root plus superior hypogastric plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pelvic cancer patients
- with pelvic pain not responding to oral analgesic medications
- side effects of oral analgesic medications
Who cannot join
- patients with metastatic cancer disease
- patients with significantly impaired organ functions
- patients with bleeding diathesis
- patients with mental disabilities
About this study
Official title: 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.
- Conditions
- Pain Cancer, Pain, Chronic
- Being tested
- superior hypogastric plexus block, pulsed radiofrequency at S3 root plus superior hypogastric plexus block
- Keywords
- pelvic cancer pain, superior hypogastric plexus block, pulsed radiofrequency
- Medical subject headings
- Cancer Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior hypogastric plexus blockProcedure or surgery
superior hypogastric plexus chemical neurolysis
pulsed radiofrequency at S3 root plus superior hypogastric plexus blockProcedure or surgery
pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | superior hypogastric plexus block Receives: Procedure: superior hypogastric plexus block |
| group 2 | Active comparator | pulsed radiofrequency at S3 nerve root + superior hypogastric plexus block Receives: Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Visual Analogue Scale post-procedure
Measured: from 30 min. after procedure to 2 months after it
Secondary outcomes (3)
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
Measured: during the block procedure and within the first 24 hours after the block
procedure time
The time required to perform the block
Measured: during the block procedure
Total oral analgesic consumption
total MST consumption
Measured: in the first 24 hours after procedures and at 1,2,4 weeks and 2 months visits after it
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mohammad Abd El-Rahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782206
- Sponsor's protocol ID
- 366
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Added Analgesic Effect of S3 Root Pulsed Radiofrequency to Superior Hypogastric Plexus Block in Pelvic Cancer Pain. a Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT04782206
- Acronym / sponsor ID
- 366
- Conditions
- Pain Cancer, Pain, Chronic
- Keywords
- pelvic cancer pain, superior hypogastric plexus block, pulsed radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: superior hypogastric plexus blocksuperior hypogastric plexus block |
| group 2 | Active comparator | Procedure: pulsed radiofrequency at S3 root plus superior hypogastric plexus blockpulsed radiofrequency at S3 nerve root + superior hypogastric plexus block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pelvic cancer patients
- with pelvic pain not responding to oral analgesic medications
- side effects of oral analgesic medications
Key exclusion criteria (4 listed)
- patients with metastatic cancer disease
- patients with significantly impaired organ functions
- patients with bleeding diathesis
- patients with mental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superior hypogastric plexus blocksuperior hypogastric plexus chemical neurolysis | Procedure or surgery | group 1 |
| pulsed radiofrequency at S3 root plus superior hypogastric plexus blockpulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis | Procedure or surgery | group 2 |
Primary outcome
pain intensity
Time frame: from 30 min. after procedure to 2 months after it
Visual Analogue Scale post-procedure
3 secondary outcomes
complications
Time frame: during the block procedure and within the first 24 hours after the block
procedure time
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing superior hypogastric plexus block and pulsed radiofrequency at S3 root plus superior hypogastric plexus block in people with Pain Cancer and Pain, Chronic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: from 30 min. after procedure to 2 months after it). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.