Pain CancerPhase 2NCT05299047
Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
A Phase 2 study testing Group US-guided and Group fluoroscopy-guided in people with Pain Cancer, run by Mansoura University at 1 site in Egypt.
Trial summary
Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Cancer
- What is being tested?
- Group US-guided and Group fluoroscopy-guided
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Sep 2022
- Phase
- Phase 2
- 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
- Patients more than 18 years old of both genders with cancer-related pelvic pain,
- poor pain control or severe side effects with opioid therapy,
- ≥ 4 on a numeric rating scale (NRS) of pain that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- positive diagnostic block day before the procedure by injecting a local anesthetic (0.25% bupivacaine 10 ml)
- Body mass index ˂ 30 were included in this study.
Who cannot join
- patient refusal,
- local or systemic sepsis,
- coagulopathy,
- unstable cardiovascular and respiratory diseases,
- previous neurological deficits,
- history of psychiatric disorders,
Show all 9Show fewer
- history of drug abuse,
- distorted local anatomy,
- those who were allergic to the used medications were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Yahya Wahba
Al Mansurah
yahya wahba, assist prof., 01211313554, yahyawahba@gmail.com
adel abdel ghaffar, pof., 01210101001, adelghaffar49@gmail.com
About this study
Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life
Read the detailed description
The superior hypogastric plexus (SHP) is one of the paravertebral sympathetic ganglia, located in the lower border of the L5 vertebra and upper part of the sacrum in the retroperitoneal space. It is considered as a continuity of the celiac plexus and the lumbar sympathetic ganglia. It is related to the bifurcation of the aorta and the ureters. The SHP has a sympathetic connection (both efferent and afferent fibers) with splanchnic nerves and aortic plexus. It innervates the viscera of the pelvis, including the urinary bladder, ureters, sigmoid colon down to the anal canal, and upper vagina SHP blockade can be performed either by ultrasound (US), fluoroscopic, computed tomography (CT) and Magnetic resonance imaging (MRI) techniques and it is conducted through anterior (transabdominal) or posterior (lateral, paramedian, oblique, transdiscal, or transvaginal) approaches These different imaging modalities and approaches have been described for SHPN to make it easier, safer and more accurate and satisfied to the patients
- Conditions
- Pain Cancer
- Being tested
- Group US-guided, Group fluoroscopy-guided
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group US-guidedOther
An ultrasound system with a 5-2 MHz curved transducer will be used. The division of the abdominal aorta into the common iliac arteries was located using oblique sonography. Then, the transducer will image the body of the fifth lumbar vertebra, at which level bilateral common iliac vessels will be seen leaving a space in the midline. a 20 cm long, 22 gauge Chiba needle will be introduced into the hypogastrium, with out-of-plane technique to access the fifth lumbar vertebral body at its anterior-most point, so that injected drug spreads equally bilaterally along the anterior curvature of the fifth lumbar vertebral body.Suction was applied to the needle to confirm that it was not within a vessel and 10 ml of 50% ethanol will be injected for neurolysis.
Group fluoroscopy-guidedOther
The patient will be placed in the supine position. The L5-S1 inter-discal space was identified under fluoroscopy.After providing local cutaneous and subcutaneous anesthesia with 2% Lignocaine solution nearly 3-4 cm below the umbilicus, a 20 cm long, 22 gauges Chiba needle is advanced to the anterior portion of the 5th vertebral body under ongoing fluoroscopic guidance. Once bony resistance is reached, gently inject 2-5 ml contrast which typical reveals a characteristic triangular blob of contrast with no vascular opacification.Before injection the needle is aspirated to confirm there is no blood. A preliminary test dose of about 3 cc of 0.5% bupivacaine is then injected. If there is no change in heart rate or neurological status, rest of the 20 cc phenol 10% is injected slowly with intermittent aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Group US-guided | Active comparator | will receive superior hypogastric plexus neurolysis by the US-guided anterior approach Receives: Other: Group US-guided |
| - Group fluoroscopy-guided | Active comparator | will receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach Receives: Other: Group fluoroscopy-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia.
Measured: 0ne hour before block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
Measured: 1 month from block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
Measured: 2 months from block
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
Measured: 3 months from block
Secondary outcomes (3)
time of the procedures
time of the procedure
Measured: intraoperative
daily analgesic requirements
dose of opioid
Measured: 3 months from injection
patient satisfaction
0 is very dissatisfied and 10 is very satisfied
Measured: 0ne month after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jan 2022
- Primary completion1 May 2022
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain CancerStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299047
- Sponsor's protocol ID
- R.22.01.1598
- Status last verified
- Aug 2022
- First submitted
- 28 Feb 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelghaffar NA, Farahat TE. Fluoroscopic anterior approach versus ultrasound guided superior hypogastric plexus neurolysis in cancer pelvic pain: a randomized controlled study. BMC Anesthesiol. 2022 Dec 27;22(1):403. doi: 10.1186/s12871-022-01948-3.
PubMed 36575390
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic Anterior Approach Versus Ultrasound Guided Superior Hypogastric Plexus Neurolysis in Cancer Pelvic Pain
- ClinicalTrials.gov ID
- NCT05299047
- Acronym / sponsor ID
- R.22.01.1598
- Conditions
- Pain Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Mar 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.
Cancer related pelvic pain can be debilitating and difficult to treat. Superior hypogastric plexus neurolysis (SHPN) is considered to be an option for adequately relieving pain, with fewer side effects and improving the quality of life
Detailed description
The superior hypogastric plexus (SHP) is one of the paravertebral sympathetic ganglia, located in the lower border of the L5 vertebra and upper part of the sacrum in the retroperitoneal space. It is considered as a continuity of the celiac plexus and the lumbar sympathetic ganglia. It is related to the bifurcation of the aorta and the ureters. The SHP has a sympathetic connection (both efferent and afferent fibers) with splanchnic nerves and aortic plexus. It innervates the viscera of the pelvis, including the urinary bladder, ureters, sigmoid colon down to the anal canal, and upper vagina SHP blockade can be performed either by ultrasound (US), fluoroscopic, computed tomography (CT) and Magnetic resonance imaging (MRI) techniques and it is conducted through anterior (transabdominal) or posterior (lateral, paramedian, oblique, transdiscal, or transvaginal) approaches These different imaging modalities and approaches have been described for SHPN to make it easier, safer and more accurate and satisfied to the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group US-guided | Active comparator | Other: Group US-guidedwill receive superior hypogastric plexus neurolysis by the US-guided anterior approach |
| - Group fluoroscopy-guided | Active comparator | Other: Group fluoroscopy-guidedwill receive superior hypogastric plexus neurolysis by the fluoroscopy-guided anterior approach |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients more than 18 years old of both genders with cancer-related pelvic pain,
- poor pain control or severe side effects with opioid therapy,
- ≥ 4 on a numeric rating scale (NRS) of pain that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- positive diagnostic block day before the procedure by injecting a local anesthetic (0.25% bupivacaine 10 ml)
Key exclusion criteria (9 listed)
- patient refusal,
- local or systemic sepsis,
- coagulopathy,
- unstable cardiovascular and respiratory diseases,
- previous neurological deficits,
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 |
|---|---|---|
| Group US-guidedAn ultrasound system with a 5-2 MHz curved transducer will be used. The division of the abdominal aorta into the common iliac arteries was located using oblique sonography. Then, the transducer will image the body of the fifth lumbar vertebra, at which level bilateral common iliac vessels will be seen leaving a space in the midline. a 20 cm long, 22 gauge Chiba needle will be introduced into the hypogastrium, with out-of-plane technique to access the fifth lumbar vertebral body at its anterior-most point, so that injected drug spreads equally bilaterally along the anterior curvature of the fifth lumbar vertebral body.Suction was applied to the needle to confirm that it was not within a vessel and 10 ml of 50% ethanol will be injected for neurolysis. | Other | Group US-guided |
| Group fluoroscopy-guidedThe patient will be placed in the supine position. The L5-S1 inter-discal space was identified under fluoroscopy.After providing local cutaneous and subcutaneous anesthesia with 2% Lignocaine solution nearly 3-4 cm below the umbilicus, a 20 cm long, 22 gauges Chiba needle is advanced to the anterior portion of the 5th vertebral body under ongoing fluoroscopic guidance. Once bony resistance is reached, gently inject 2-5 ml contrast which typical reveals a characteristic triangular blob of contrast with no vascular opacification.Before injection the needle is aspirated to confirm there is no blood. A preliminary test dose of about 3 cc of 0.5% bupivacaine is then injected. If there is no change in heart rate or neurological status, rest of the 20 cc phenol 10% is injected slowly with intermittent aspiration. | Other | - Group fluoroscopy-guided |
Primary outcome
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Time frame: 0ne hour before block
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia.
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Time frame: 1 month from block
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Time frame: 2 months from block
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS)
Time frame: 3 months from block
It includes the assessment of 10 symptoms experienced by cancer patients with the following 0-10 numeric rating scales: pain, fatigue, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, feeling of well-being, and insomnia
3 secondary outcomes
time of the procedures
Time frame: intraoperative
daily analgesic requirements
Time frame: 3 months from injection
patient satisfaction
Time frame: 0ne month after block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Derived from this study: PubMed 36575390Abdelghaffar NA, Farahat TE. Fluoroscopic anterior approach versus ultrasound guided superior hypogastric plexus neurolysis in cancer pelvic pain: a randomized controlled study. BMC Anesthesiol. 2022 Dec 27;22(1):403. doi: 10.1186/s12871-022-01948-3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group US-guided and Group fluoroscopy-guided in people with Pain Cancer, run by Mansoura 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 6 inclusion and 9 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 16 Aug 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 yahya m wahba (01211313554, yahyawahba@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The symptom burden was evaluated using the Edmonton Symptom Assessment System (ESAS) (time frame: 0ne hour before block). The study lists 4 primary outcomes in all. 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 NCT05299047, which also lists 1 linked publication.
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 16 Aug 2022.