Chronic Pelvic Cancer PainNCT03228316
Superior Hypogastric Plexus Block Versus Pulsed Radiofrequency for Chronic Pelvic Cancer Pain
A study testing superior hypogastric plexus block and pulsed radiofrequency in people with Chronic Pelvic Cancer Pain, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pelvic Cancer Pain
- What is being tested?
- superior hypogastric plexus block and 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
- No sites listed yet
- Study dates
- 20 Oct 2019to 20 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain
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
Read the detailed description
pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix, endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate that the prevalence of pain in patients with pelvic cancer is >50%, and can be upwards of 60% to 70% in patients with advanced or metastatic disease . Cancer patients with extension of tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only fail to provide relief, but may cause excessive sedation and other side effects. More invasive approaches may thus be needed to control pain and improve the quality of life. Since pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk between these levels. It is an extension of the aortic plexus below the aortic bifurcation, and contains almost exclusively sympathetic fibers and visceral afferents . Afferent pain fibers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami; thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer pain. Several studies examined the use of superior hypogastric plexus block in the treatment of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither the follow-up period nor the proportion with a successful prognostic block were noted. Radiofrequency utilizes a high-frequency alternating current that is passed from the needle electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to the accuracy of lesions produced by radiofrequency ablation, there has been growing interest in the use of this technique for neurolysis of nerves as it offers the potential of accurate nerve destruction ablation, with a predictable and controlled ablative lesion. Another advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and phenol, which may take up to 1 week or 10 days to achieve neurolysis .
- Conditions
- Chronic Pelvic Cancer Pain
- Being tested
- superior hypogastric plexus block, pulsed radiofrequency
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
nerve plexus block
pulsed radiofrequencyRadiation
pulsed radiofrequency on sacral nerve roots 2,3 and 4
| Study group | Role | What they receive |
|---|---|---|
| the study group one | Experimental | 20 patients with superior hypogastric plexus block Receives: Procedure: superior hypogastric plexus block |
| the study group two | Experimental | 20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4 Receives: Procedure: superior hypogastric plexus block; Radiation: pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score for pain
Points on a scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start20 Oct 2019 (estimated)
- Primary completion20 Jun 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Cancer PainStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marina emeel helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228316
- Sponsor's protocol ID
- MEHG
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27208713Hetta 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.
PubMed 32214294
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superior Hypogastric Plexus Block and Pulsed Radiofrequency on Dorsal Root Ganglia of Sacral Nerves for Chronic Pelvic Cancer Pain
- ClinicalTrials.gov ID
- NCT03228316
- Acronym / sponsor ID
- MEHG
- Conditions
- Chronic Pelvic Cancer Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2019 (estimated)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 24 Jul 2017 (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.
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
Detailed description
pelvic cancer is a broad term encompassing malignant tumors of the bladder, prostate, cervix, endometrium, ovaries, and uterus, among others. Pain associated with pelvic cancer is one of the most debilitating symptoms experienced by affected patients. Multiple studies demonstrate that the prevalence of pain in patients with pelvic cancer is >50%, and can be upwards of 60% to 70% in patients with advanced or metastatic disease . Cancer patients with extension of tumor into the pelvis may experience severe pain. Oral or parenteral opioids may not only fail to provide relief, but may cause excessive sedation and other side effects. More invasive approaches may thus be needed to control pain and improve the quality of life. Since pelvic cancer pain is visceral in most cases, this could be achieved with percutaneous chemical neurolytic block of the superior hypogastric plexus . The superior hypogastric plexus is located at the anterior aspect of the L5 and S1 vertebrae, and traverses the disk between these levels. It is an extension of the aortic plexus below the aortic bifurcation, and contains almost exclusively sympathetic fibers and visceral afferents . Afferent pain fibers innervating pelvic organs travel with sympathetic nerves, trunks, ganglia, and rami; thus, interrupting the sympathetic chain at this level can be used to treat pelvic cancer pain. Several studies examined the use of superior hypogastric plexus block in the treatment of pelvic cancer pain. Although the authors reported a mean reduction in pain of 70%, neither the follow-up period nor the proportion with a successful prognostic block were noted. Radiofrequency utilizes a high-frequency alternating current that is passed from the needle electrode into the surrounding tissue, resulting in frictional heating and necrosis. Due to the accuracy of lesions produced by radiofrequency ablation, there has been growing interest in the use of this technique for neurolysis of nerves as it offers the potential of accurate nerve destruction ablation, with a predictable and controlled ablative lesion. Another advantage of radiofrequency ablation is that it has an immediate effect unlike alcohol and phenol, which may take up to 1 week or 10 days to achieve neurolysis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the study group one | Experimental | Procedure: superior hypogastric plexus block20 patients with superior hypogastric plexus block |
| the study group two | Experimental | Procedure: superior hypogastric plexus block, Radiation: pulsed radiofrequency20 patients with superior hypogastric plexus block combined to pulsed radiofrequency on sacral nerve roots 2,3 and 4 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 blocknerve plexus block | Procedure or surgery | the study group one, the study group two |
| pulsed radiofrequencypulsed radiofrequency on sacral nerve roots 2,3 and 4 | Radiation | the study group two |
Primary outcome
Visual analogue score for pain
Time frame: 2 months
Points on a scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 27208713Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004.
- Derived from this study: PubMed 32214294Hetta 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing superior hypogastric plexus block and pulsed radiofrequency in people with Chronic Pelvic Cancer Pain, 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 4 inclusion and 7 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 2 Jul 2019. 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?
Contact Fatma Ahmed Abdel Aal, professor (01113221317 ext. 002, Fatmaabdelal23@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score for pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228316, which also lists 2 linked publications.
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 2 Jul 2019.