AnalgesiaNCT05591430
Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
A study testing Ganglion Impar Neurolysis and Bilateral S2, S3 and S4 Pulsed radiofrequency in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Ganglion Impar Neurolysis and Bilateral S2, S3 and S4 Pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2022to 30 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-75 years
- ASA II-III with perianal and perineal pain related to cancer
Who cannot join
- patient refusal
- coagulation defects
- abnormal kidney or liver functions
- local infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Pulsed Radiofrequency of Dorsal Root Ganglia of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.
Read the detailed description
Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Ganglion impar block has been traditionally used for treatment of such perineal pain. Radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.
- Conditions
- Analgesia
- Being tested
- Ganglion Impar Neurolysis, Bilateral S2, S3 and S4 Pulsed radiofrequency
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganglion Impar NeurolysisProcedure or surgery
block of Ganglion Impar by neurolytic drug
Bilateral S2, S3 and S4 Pulsed radiofrequencyProcedure or surgery
Bilateral S2, S3 and S4 Pulsed radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Ganglion Impar Neurolysis | Active comparator | Block of ganglion impar using neurolytic Receives: Procedure: Ganglion Impar Neurolysis |
| Bilateral S2, S3 and S4 Pulsed radiofrequency | Experimental | Pulsed radiofrequency of S2-S4 Receives: Procedure: Bilateral S2, S3 and S4 Pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
the score of visual analogue scale score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start28 Oct 2022
- Primary completion25 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591430
- Sponsor's protocol ID
- AP2207-50108
- Status last verified
- Jun 2024
- First submitted
- 19 Oct 2022
- Last updated
- 24 Jun 2024
- 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 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Pulsed Radiofrequency of Dorsal Root Ganglia of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT05591430
- Acronym / sponsor ID
- AP2207-50108
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 24 Oct 2022 (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.
Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.
Detailed description
Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Ganglion impar block has been traditionally used for treatment of such perineal pain. Radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ganglion Impar Neurolysis | Active comparator | Procedure: Ganglion Impar NeurolysisBlock of ganglion impar using neurolytic |
| Bilateral S2, S3 and S4 Pulsed radiofrequency | Experimental | Procedure: Bilateral S2, S3 and S4 Pulsed radiofrequencyPulsed radiofrequency of S2-S4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18-75 years
- ASA II-III with perianal and perineal pain related to cancer
Key exclusion criteria (4 listed)
- patient refusal
- coagulation defects
- abnormal kidney or liver functions
- local infection at site of injection
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 |
|---|---|---|
| Ganglion Impar Neurolysisblock of Ganglion Impar by neurolytic drug | Procedure or surgery | Ganglion Impar Neurolysis |
| Bilateral S2, S3 and S4 Pulsed radiofrequencyBilateral S2, S3 and S4 Pulsed radiofrequency | Procedure or surgery | Bilateral S2, S3 and S4 Pulsed radiofrequency |
Primary outcome
Visual analogue scale
Time frame: 2 hours
the score of visual analogue scale score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
Walaa Y Elsabeeny, MD principal investigator
Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganglion Impar Neurolysis and Bilateral S2, S3 and S4 Pulsed radiofrequency in people with Analgesia, run by National Cancer Institute, Egypt at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale (time frame: 2 hours). 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 24 Jun 2024.