Post-mastectomy Pain SyndromeNCT05771103
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
A study testing thermal Radiofrequency neurolysis of Stellate ganglion in people with Post-mastectomy Pain Syndrome, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy. Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- thermal Radiofrequency neurolysis of Stellate ganglion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Jul 2023
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patient 20-65yrs underwent surgery for breast cancer
- Pain duration of more than 6 months
- Pain is moderate to severe pain (visual analog scale [VAS] ≥ 4 cm),
- Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective
- Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4
Who cannot join
- Refusal of the patient
- Recent myocardial infarction
- Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio)
- Glaucoma
- Pre-existing counter lateral nerve palsy
- Severe emphysema
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- Cardiac conduction block
- Local and systemic sepsis
- Local anatomical distortion (which may render the block technically difficult or hazardous.
- Psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
Read the detailed description
Breast cancer is the most common cause of cancer death for women . Postmastectomy pain syndrome (PMPS) is a frequent complication of breast surgery, and is considered a chronic neuropathic pain in the side of surgery which persists more than 3 months.
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.
The stellate ganglion (SG), also known as the cervico-thoracic ganglion, is part of the sympathetic nervous system.
After assessment of eligibility criteria a predetermined randomization list and will be generated using random blocks.
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice has to be 0.5 cm apart from each other . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
- Group A ,The procedure will be started by placing the needle tip аntеrоlаteral to the lоngusсоlli muscle, dееp to the prеvеrtebrаlfаsсia in оrdеr tо аvоid spread along the carotid sheath, but superficial to the fascia investing the longus colli muscle (to prevent injecting into the muscle). Identifying the correct fascial plane achieved with portable ultrasound guidance thus facilitating the caudal spread of the injectate to reach the stellate ganglion at the C7-T1 level. This allowed for a more effective and stable sympathetic block with the use of a small injected volume. As an injection, we firstly used 1%-2.0 ml of lidocaine. The procedure will be continued by the injection of ethanol 50%, in quantity 1.5 ml for a lasting effect.
- Group B, thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
- Conditions
- Post-mastectomy Pain Syndrome
- Being tested
- thermal Radiofrequency neurolysis of Stellate ganglion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal Radiofrequency neurolysis of Stellate ganglionDevice
Also called Stellate ganglion block with alcohol injection
Stellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion block with alcohol injection | Active comparator | Stellate ganglion block with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy. Receives: Device: thermal Radiofrequency neurolysis of Stellate ganglion |
| thermal RF neurolysis of Stellate ganglion | Active comparator | Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance Receives: Device: thermal Radiofrequency neurolysis of Stellate ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in VAS
assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks . A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 100 mm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
Measured: 12 WEEKS
Secondary outcomes (1)
patient satisfaction by patient satisfaction score and the analgesic concomitant medications consumption will be assessed before and 1,4,8 and 12 weeks after block
satisfaction score where 0 dissatisfied ,10 very satisfied
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 posted16 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Pain SyndromeStudies 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
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- suzan adlan, lecturer, Principal investigator, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771103
- Sponsor's protocol ID
- AP2212-501-027
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
- ClinicalTrials.gov ID
- NCT05771103
- Acronym / sponsor ID
- AP2212-501-027
- Conditions
- Post-mastectomy Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 16 Mar 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.
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
Detailed description
Breast cancer is the most common cause of cancer death for women . Postmastectomy pain syndrome (PMPS) is a frequent complication of breast surgery, and is considered a chronic neuropathic pain in the side of surgery which persists more than 3 months.
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.
The stellate ganglion (SG), also known as the cervico-thoracic ganglion, is part of the sympathetic nervous system.
After assessment of eligibility criteria a predetermined randomization list and will be generated using random blocks.
- Group A: SGB with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy.
- Group B: Thermal RF; thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice has to be 0.5 cm apart from each other . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
- Group A ,The procedure will be started by placing the needle tip аntеrоlаteral to the lоngusсоlli muscle, dееp to the prеvеrtebrаlfаsсia in оrdеr tо аvоid spread along the carotid sheath, but superficial to the fascia investing the longus colli muscle (to prevent injecting into the muscle). Identifying the correct fascial plane achieved with portable ultrasound guidance thus facilitating the caudal spread of the injectate to reach the stellate ganglion at the C7-T1 level. This allowed for a more effective and stable sympathetic block with the use of a small injected volume. As an injection, we firstly used 1%-2.0 ml of lidocaine. The procedure will be continued by the injection of ethanol 50%, in quantity 1.5 ml for a lasting effect.
- Group B, thermal RF neurolysis will be applied with a time of 60 seconds at 80º C, and then will be repeated twice . Stellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion block with alcohol injection | Active comparator | Device: thermal Radiofrequency neurolysis of Stellate ganglionStellate ganglion block with alcohol injection by ultrasound guidance and C7 level confirmation by fluoroscopy. |
| thermal RF neurolysis of Stellate ganglion | Active comparator | Device: thermal Radiofrequency neurolysis of Stellate ganglionStellate ganglion RF therapy will be done under fluoroscopy, integrated by ultrasound guidance |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patient 20-65yrs underwent surgery for breast cancer
- Pain duration of more than 6 months
- Pain is moderate to severe pain (visual analog scale [VAS] ≥ 4 cm),
- Pain described as a refractory one that is defined as pain for which classic biomedical therapy has proven ineffective
- Pain is of positive neuropathic character as detected by the grading system for neuropathic pain (GSNP), with a score of 3 or 4
Key exclusion criteria (10 listed)
- Refusal of the patient
- Recent myocardial infarction
- Anti-coagulated patients or coagulopathy (evaluate risk/benefit ratio)
- Glaucoma
- Pre-existing counter lateral nerve palsy
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 |
|---|---|---|
| thermal Radiofrequency neurolysis of Stellate ganglionAlso: Stellate ganglion block with alcohol injectionStellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate ganglion | Device | Stellate ganglion block with alcohol injection, thermal RF neurolysis of Stellate ganglion |
Primary outcome
Changes in VAS
Time frame: 12 WEEKS
assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks . A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 10 cm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain). Changes in VAS for assessment of pain relief pre and post neuro destruction of stellate ganglion 1, 4, 8 and 12 weeks. A 100 mm horizontal line version was used with 2 ends (left-end means no pain and right-end means the worst pain).
1 secondary outcome
patient satisfaction by patient satisfaction score and the analgesic concomitant medications consumption will be assessed before and 1,4,8 and 12 weeks after block
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Post-mastectomy Pain Syndrome
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Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
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Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
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Super-voltage PRF of Stellate Ganglion Versus Super-voltage PRF of T2 T3 Sympathetic Ganglia in Managing PMPS.
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Dex & Mastectomy Pain
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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.
suzan adlan, lecturer principal investigator
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal Radiofrequency neurolysis of Stellate ganglion in people with Post-mastectomy Pain Syndrome, 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 5 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 2 Aug 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 suzan adlan, lecturer (01111068300, dr_s.adlan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 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 2 Aug 2023.