Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771103
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2023-02-21
Brief Title:
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
Sponsor:
National Cancer Institute Egypt
Organization:
National Cancer Institute Egypt
Study Overview
Official Title:
Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 05 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 1-20 ml of lidocaine The procedure will be continued by the injection of ethanol 50 in quantity 15 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
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 05 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 1-20 ml of lidocaine The procedure will be continued by the injection of ethanol 50 in quantity 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None