Intractable Pelvic Cancer PainNCT03606811
Fluoroscopic &Ultrasonographic Guidance of Superior Hypogastric Plexus Neurolysis in Intractable Pelvic Pain
A study testing fluroscopic guided block and double modality (ultrasound and fluroscopic) guided block in people with Intractable Pelvic Cancer Pain, run by Assiut University at 1 site in Egypt.
Trial summary
fluoroscopic group \& includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group \& includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intractable Pelvic Cancer Pain
- What is being tested?
- fluroscopic guided block and double modality (ultrasound and fluroscopic) guided block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2018to 15 Aug 2019
- 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
- Age > 18 years.
- Intractable pelvic cancer pain (VAS > 40 mm)
- Pain is refractory to pharmacotherapy (both opioids and adjuvant therapy) or opioids' side effects are not tolerated.
Who cannot join
- Local or systemic sepsis.
- Uncorrectable coagulopathy.
- Neuropsychiatric illness.
- History of drug abuse.
- Pregnant or lactating patients.
- Distorted local anatomy.
- Patients who are known to be allergic to the used medications.
- Cardiovascular or respiratory instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Double Modality " Fluoroscopic &Ultrasonographic " Guidance of Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: a Comparative Study.
fluoroscopic group \& includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group \& includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position.
- Conditions
- Intractable Pelvic Cancer Pain
- Being tested
- fluroscopic guided block, double modality (ultrasound and fluroscopic) guided block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluroscopic guided blockProcedure or surgery
SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.
double modality (ultrasound and fluroscopic) guided blockProcedure or surgery
SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A \& dead lateral)
| Study group | Role | What they receive |
|---|---|---|
| fluroscopic guided block | Active comparator | Not described Receives: Procedure: fluroscopic guided block |
| double modality guided block | Experimental | Not described Receives: Procedure: double modality (ultrasound and fluroscopic) guided block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief will be assessed by VAS
pain relief will be assessed by VAS (visual Analogue score) which is 100 mscale with left (0) end means no pain \& right (10) end means the worst possible pain
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start5 Aug 2018
- Primary completion1 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed H Othman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606811
- Sponsor's protocol ID
- IORG0003301
- Status last verified
- Jan 2020
- First submitted
- 14 Jul 2018
- Last updated
- 14 Jan 2020
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Double Modality " Fluoroscopic &Ultrasonographic " Guidance of Superior Hypogastric Plexus Neurolysis in Treating Intractable Pelvic Cancer Pain: a Comparative Study.
- ClinicalTrials.gov ID
- NCT03606811
- Acronym / sponsor ID
- IORG0003301
- Conditions
- Intractable Pelvic Cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 31 Jul 2018 (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.
fluoroscopic group \& includes 30 patients where SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.the double modality group \& includes 30 patients where SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluroscopic guided block | Active comparator | Procedure: fluroscopic guided block |
| double modality guided block | Experimental | Procedure: double modality (ultrasound and fluroscopic) guided block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Intractable pelvic cancer pain (VAS > 40 mm)
- Pain is refractory to pharmacotherapy (both opioids and adjuvant therapy) or opioids' side effects are not tolerated.
Key exclusion criteria (8 listed)
- Local or systemic sepsis.
- Uncorrectable coagulopathy.
- Neuropsychiatric illness.
- History of drug abuse.
- Pregnant or lactating patients.
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 |
|---|---|---|
| fluroscopic guided blockSHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique. | Procedure or surgery | fluroscopic guided block |
| double modality (ultrasound and fluroscopic) guided blockSHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A \& dead lateral) | Procedure or surgery | double modality guided block |
Primary outcome
pain relief will be assessed by VAS
Time frame: 12 weeks
pain relief will be assessed by VAS (visual Analogue score) which is 100 mscale with left (0) end means no pain \& right (10) end means the worst possible 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 14 Jan 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluroscopic guided block and double modality (ultrasound and fluroscopic) guided block in people with Intractable Pelvic Cancer Pain, run by Assiut University 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 3 inclusion and 8 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 14 Jan 2020. 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?
pain relief will be assessed by VAS (time frame: 12 weeks). 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 14 Jan 2020.