NCT05771103

Stellate Ganglion Destruction With Alcohol Versus Thermal Ablation for Chronic Post Mastectomy Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: National Cancer Institute, Egypt · Academic / Other
• Sex: Female
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Post-mastectomy Pain Syndrome

Interventions

Type	Name	Description
DEVICE	thermal Radiofrequency neurolysis of Stellate ganglion	Stellate ganglion block with alcohol injection versus thermal RF neurolysis of Stellate ganglion

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2023-03-16
• Last updated: 2023-08-02

Locations

1 site across 1 country: Egypt