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Trial Title:
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
NCT ID:
NCT05771103
Condition:
Post-mastectomy Pain Syndrome
Conditions: Official terms:
Ganglion Cysts
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
thermal Radiofrequency neurolysis of Stellate ganglion
Description:
Stellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate
ganglion
Arm group label:
Stellate ganglion block with alcohol injection
Arm group label:
thermal RF neurolysis of Stellate ganglion
Other name:
Stellate ganglion block with alcohol injection
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 . 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Cardiac conduction block
- Local and systemic sepsis
- Local anatomical distortion (which may render the block technically difficult or
hazardous.
- Psychiatric illness.
Gender:
Female
Gender based:
Yes
Gender description:
female underwent radical mastectomy because of breast cancetr
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
NCIEgypt IRB office
Address:
City:
Cairo
Zip:
11796
Country:
Egypt
Status:
Recruiting
Start date:
January 1, 2023
Completion date:
July 30, 2023
Lead sponsor:
Agency:
National Cancer Institute, Egypt
Agency class:
Other
Source:
National Cancer Institute, Egypt
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771103
