Stellate GanglionNCT06033456
Combining Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post-mastectomy Complex Regional Pain Syndrome
A study testing Radiofrequency stellate ganglion block using ultrasound guidance (SGB), Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) and Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block in people with Stellate Ganglion and Radiofrequency Ablation, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Stellate Ganglion, Radiofrequency Ablation, Complex Regional Pain Syndromes
- What is being tested?
- Radiofrequency stellate ganglion block using ultrasound guidance (SGB), Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) and Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2023to 15 Mar 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients.
- Type of surgery: Modified Radical Mastectomy MRM.
- Physical status ASA II, III.
- Duration of more than 6 months and less than 2 years.
- Moderate and severe pain (visual analog scale [VAS] ≥ 40 mm).
- Pain described as a refractory to strong opioids (oxycodone) and adjuvant therapy such as(pregabalin) for which more invasive interventions could be tried.
Who cannot join
- Patient refusal.
- Patient with local and systemic sepsis.
- Local anatomical distortion.
- History of contralateral chest disease or pneumonectomy.
- Known sensitivity or contraindication to the drug used in the study.
- History of psychological disorders.
Show all 10Show fewer
- Contraindication to regional anesthesia, e.g., pre-existing peripheral neuropathies and coagulopathy.
- Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
- Pregnancy.
- Physical status ASA IV and Male patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Mary S Gerges, MD, 00201222610774, Marysabry136@gmail.com
Mahmoud A Kamel, MD
About this study
Official title: Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
The aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).
Read the detailed description
Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.
Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.
- Being tested
- Radiofrequency stellate ganglion block using ultrasound guidance (SGB), Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB), Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency stellate ganglion block using ultrasound guidance (SGB)Procedure or surgery
Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8).
Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning
Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)Procedure or surgery
Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location.
Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral blockProcedure or surgery
Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency stellate ganglion block using ultrasound guidance (SGB) | Experimental | Visualization of the C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex.
Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning . Receives: Procedure: Radiofrequency stellate ganglion block using ultrasound guidance (SGB) |
| Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance | Experimental | Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location. Receives: Procedure: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) |
| Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block | Experimental | Combination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block. Receives: Procedure: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain relief
Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention.
Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.
Measured: 3 months after intervention
Secondary outcomes (5)
Patient satisfaction
Patient satisfaction by patient satisfaction score (0 very satisfied and 10 dissatisfied)
Measured: 3 months after intervention
Oxycodone consumption
The analgesic concomitant medications (oxycodone) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Measured: 3 months after intervention
Pregabalin consumption
The analgesic concomitant medications (pregabalin) consumption will be assessed prior to the block and at 1st day, 1,3 months.
Measured: 3 months after intervention
neuropathic pain
Neuropathic pain will be evaluated according to the Grading System for Neuropathic Pain (GSNP).
Positive neuropathic cases are those with GSNP 3 (probable) or GSNP 4 (definite) .
The grading system for neuropathic pain (GSNP) is as follows: Grade 1 (unlikely), Grade 2 (possible), Grade 3 (probable), and Grade 4 (definite)
Measured: 3 months
Patient's Quality of life
Patient's Quality of life according to WHOQOL(who measure quality of life)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Oct 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate GanglionStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Sabry, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033456
- Sponsor's protocol ID
- AP2302-301-0001
- Status last verified
- Oct 2023
- First submitted
- 5 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination of Stellate Ganglion and T2 and T3 Radiofrequency Ablation on Post Mastectomy Complex Regional Pain Syndrome, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06033456
- Acronym / sponsor ID
- AP2302-301-0001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 13 Sep 2023 (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 aim of this study is to evaluate the efficacy of the combination of Ultra Sound (US) guided radiofrequency stellate ganglion block (SGB) and radiofrequency Thoracic Paravertebral block (TPVB) comparing to US-guided SGB or TPVB alone on the post-mastectomy pain syndrome (PMPS).
Detailed description
Breast cancer is the most common malignancy among females, with an incidence of about 2.1 million women each year. It is the most common cause of cancer-related deaths among women. Modified Radical Mastectomy (MRM) is one of the main surgical treatments for breast cancer. It accounts for 31% of all breast surgery cases. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post-mastectomy pain syndrome.
Complex regional pain syndrome (CRPS) is a clinical diagnosis with a highly variable presentation and prognosis. CRPS type I, previously known as reflex sympathetic dystrophy (RSD), is not associated with direct nerve injury. CRPS type II, or causalgia, is associated with direct injury of a specific nerve, often from surgical intervention or trauma. Symptoms include severe pain, sensitivity to light touch, burning, sweating, skin discoloration, edema, temperature changes, loss of motor function, and decreased range of motion of the affected limb. The mechanism of CRPS is not fully understood with central and peripheral sensitization involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency stellate ganglion block using ultrasound guidance (SGB) | Experimental | Procedure: Radiofrequency stellate ganglion block using ultrasound guidance (SGB)Visualization of the C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex. Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning . |
| Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance | Experimental | Procedure: Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location. |
| Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block | Experimental | Procedure: Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral blockCombination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients.
- Type of surgery: Modified Radical Mastectomy MRM.
- Physical status ASA II, III.
- Duration of more than 6 months and less than 2 years.
- Moderate and severe pain (visual analog scale [VAS] ≥ 40 mm).
Key exclusion criteria (10 listed)
- Patient refusal.
- Patient with local and systemic sepsis.
- Local anatomical distortion.
- History of contralateral chest disease or pneumonectomy.
- Known sensitivity or contraindication to the drug used in the study.
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 |
|---|---|---|
| Radiofrequency stellate ganglion block using ultrasound guidance (SGB)Visualization of C6-C7 level will be targeted under fluoroscopic posterior-anterior (PA) guidance. Skin will be infiltrated with 1% lidocaine using a 25-gauge needle. Next, the RF needle will be inserted under a trajectory approach toward the target. Then, with ultrasound guidance, using a superficial linear ultrasound probe to guide further needle penetration so that the needle-tip will lie anterior to the longus colli muscle, the exclusion of vascular structures will be confirmed by duplex(8). Then, 5 to 1 mL of omnipaque dye (iohexol) will be injected. Subsequently, a 100 mm length Baily RF electrode will be inserted and connected to the generator. The RF needle will be positioned alongside the stellate ganglion in the thermal RF technique. With repeated sensory and motor stimulation before RF lesioning | Procedure or surgery | Radiofrequency stellate ganglion block using ultrasound guidance (SGB) |
| Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB)Radiofrequency sympathectomy will be performed with the patient in the prone position. Under fluoroscopic guidance, the T2, T3 vertebral bodies will be identified in an anteroposterior view. For radiofrequency sympathectomy, 10 cm curved, sharp radiofrequency insulated needle with an active tip of 10 mm, needle entry will be performed, and the final placement of the needle tip will be located at the posterior third of the vertebral body in lateral view and just lateral to the body in the anteroposterior view. Once the correct position is confirmed, 0.5 to 1 ml of Omnipaque will be injected, then a 10 cm electrode will be introduced through the RF needle. Before lesioning, a sensory and motor test stimulation is performed to verify the location. | Procedure or surgery | Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance |
| Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral blockCombination between radiofrequency of stellate ganglion block and thoracic T2, T3 paravertebral block. | Procedure or surgery | Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block |
Primary outcome
The degree of pain relief
Time frame: 3 months after intervention
Pain relief is assessed by the change in Visual Analogue Scale (VAS) score at 1st day then 1 and 3 months after intervention. Complete response VAS 0-3. • Partial response VAS 4-6. • No response VAS 7-10.
5 secondary outcomes
Patient satisfaction
Time frame: 3 months after intervention
Oxycodone consumption
Time frame: 3 months after intervention
Pregabalin consumption
Time frame: 3 months after intervention
neuropathic pain
Time frame: 3 months
Patient's Quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 study testing Radiofrequency stellate ganglion block using ultrasound guidance (SGB), Radiofrequency thoracic (T2, T3) paravertebral block under fluoroscopic guidance (TPVB) and Combined radiofrequency of stellate ganglion block plus thoracic T2, T3 paravertebral block in people with Stellate Ganglion and Radiofrequency Ablation, 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 6 inclusion and 10 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 10 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary S Gerges (00201222610774, Marysabry136@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain relief (time frame: 3 months after intervention). 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 10 Oct 2023.