Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema

Study Overview
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Brief Summary
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Lymphedema is a condition characterized by generalized or regional accumulation of protein-rich interstitial fluid as a result of impaired lymphatic circulation due to congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical criteria. Lymphedema is mostly evaluated through arm circumference measurements, water displacement measurements, tonometry, bioimpedance analysis, ultrasonography (US), computed tomography, lymphoscintigraphy and magnetic resonance imaging (MRI). Targets in the treatment of lymphedema include controlling the symptoms and preventing complications. A multimodal technique called complete decongestive therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the literature, there are also studies showing that stellate ganglion block in breast cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI, there has been increasing interest in ultrasound-guided technique since it has been fast, easy and cost-effective for the last few years. However, there are limited studies to provide sufficient evidence for the use of stellate ganglion block as an alternative treatment for lymphedema and detailed studies are needed in this area. The aim of this study is ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of patients with breast cancer related lymphedema that is resistant to conservative treatment methods .

Detailed Description
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Lymphedema is a condition characterized by generalized or regional accumulation of protein-rich interstitial fluid as a result of impaired lymphatic circulation due to congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical criteria. In addition to swelling of the affected extremities, certain symptoms, such as pain, fatigue, tightness, heaviness, tingling, weakness, and movement restriction, can also be seen in cases of lymphedema. Arm circumference measurements and volumetric methods are the most commonly used methods for calculating limb volume. In addition, soft tissue edema can be quantitatively measured by ultrasonography (US), computed tomography, lymphoscintigraphy and magnetic resonance imaging (MRI). Among these, US has been used more frequently in the evaluation of lymphedema. Ultrasonographic evaluation of the skin and subcutaneous tissue helps to determine the severity of lymphedema and the effectiveness of treatment. The reliability and utility of ultrasound in subcutaneous echogenicity grade (SEG) and subcutaneous echo-free space (SEFS) grade have been demonstrated in patients with breast cancer-related lymphedema. Targets in the treatment of lymphedema include controlling the symptoms and preventing complications. A multimodal technique called complete decongestive therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the literature, there are also studies showing that stellate ganglion block in breast cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI, there has been increasing interest in ultrasound-guided technique since it has been fast, easy and cost-effective for the last few years. However, there are limited studies to provide sufficient evidence for the use of stellate ganglion block as an alternative treatment for lymphedema and detailed studies are needed in this area. The aim of this study is ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of patients with breast cancer related lymphedema that is resistant to conservative treatment methods. Patients with breast cancer-related lymphedema will be evaluated for the study. For the diagnosis of lymphedema, detailed physical examination and limb circumference measurements will be performed. The patients with stage 2-3 lymphedema according to ISL staging, who had passed at least 3 months after breast surgery and did not response to conservative treatment methods will be included to the study. After obtaining written and oral informed consent of patients, US- guided stellate ganglion block will be applied two times at two-week intervals. Patients will be evaluated before injections (weeks 0 and 2) and 2 weeks after the last injection (week 4) and at 3 months of treatment. Arm circumference will be measured from 5 different areas, shoulder range of motion (ROM) will be evaluated with a goniometer, pain, and tightness and heaviness sensation will be assessed with visual analog scale. Quick-DASH questionnaire and Lymphedema Life Impcat scale will be applied to the patients. SEG and SEFS grade will be performed by evaluating subcutaneous tissue with USG. After data collection, analysis will be performed with the appropriate statistical method.

Official Title
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Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema

Conditions
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Lymphedema of Upper Limb, Breast Cancer Related Lymphedema

Intervention / Treatment
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* Combination Product: bupivacaine and triamcinolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: circumference difference of 2 cm or more between the affected and unaffected arm stage 2-3 lymphedema according to ISL staging aged between 18-70 years at least 3 months of follow-up breast surgery no response to the complete decongestive therapy enough Exclusion Criteria: signs of cellulitis, lymphangitis, fungal infection, metastases to the lymph nodes uncontrolled psychiatric and systemic diseases contraindications for stellate ganglion block

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stellate ganglion block in breast cancer related lymphedema<br>US-guided stellat ganglion block will be applied to the patients with breast cancer related lymphedema twice at two-week intervals. | Combination Product: bupivacaine and triamcinolone<br>* a mixture of 4 mL 0.5% bupivacaine (marcaine) and 1 mL 40 mg triamcinolone (kenacort-a)<br>* Other names: Kenacort-a;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm circumference difference | Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities. | before treatment (T0) | 
| Arm circumference difference | Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities. | 2nd week of treatment (T1) | 
| Arm circumference difference | Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities. | 4th week of treatment (T2) | 
| Arm circumference difference | Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities. | 3rd month of treatment (T3) | 
| Subcutaneous echogenicity grade (SEG) | SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity | before treatment (T0) | 
| Subcutaneous echogenicity grade (SEG) | SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity | 2nd week of treatment (T1) | 
| Subcutaneous echogenicity grade (SEG) | SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity | 4th week of treatment (T2) | 
| Subcutaneous echogenicity grade (SEG) | SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity | 3rd month of treatment (T3) | 
| Subcutaneous echo-free space (SEFS) grade | SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs. | before treatment (T0) | 
| Subcutaneous echo-free space (SEFS) grade | SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs. | 2nd week of treatment (T1) | 
| Subcutaneous echo-free space (SEFS) grade | SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs. | 4th week of treatment (T2) | 
| Subcutaneous echo-free space (SEFS) grade | SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs. | 3rd month of treatment (T3) | 
| shoulder range of motion (ROM) will be evaluated with a goniometer | Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation. | before treatment (T0) | 
| shoulder range of motion (ROM) will be evaluated with a goniometer | Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation. | 2nd week of treatment (T1) | 
| shoulder range of motion (ROM) will be evaluated with a goniometer | Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation. | 4th week of treatment (T2) | 
| shoulder range of motion (ROM) will be evaluated with a goniometer | Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation. | 3rd month of treatment (T3) | 
| Pain, tightness and heaviness sensation | Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from 0 cm (no discomfort) to 10 cm (worst imaginable) | before treatment (T0) | 
| Pain, tightness and heaviness sensation | Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from 0 cm (no discomfort) to 10 cm (worst imaginable) | 2nd week of treatment (T1) | 
| Pain, tightness and heaviness sensation | Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from 0 cm (no discomfort) to 10 cm (worst imaginable) | 4th week of treatment (T2) | 
| Pain, tightness and heaviness sensation | Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from 0 cm (no discomfort) to 10 cm (worst imaginable) | 3rd month of treatment (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity and participation - Quick-DASH | Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al. | before treatment (T0) | 
| Activity and participation - Quick-DASH | Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al. | 2nd week of treatment (T1) | 
| Activity and participation - Quick-DASH | Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al. | 4th week of treatment (T2) | 
| Activity and participation - Quick-DASH | Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al. | 3rd month of treatment (T3) | 
| Quality of life - Lymphedema Life Impact Scale | Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al. | before treatment (T0) | 
| Quality of life - Lymphedema Life Impact Scale | Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al. | 2nd week of treatment (T1) | 
| Quality of life - Lymphedema Life Impact Scale | Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al. | 4th week of treatment (T2) | 
| Quality of life - Lymphedema Life Impact Scale | Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al. | 3rd month of treatment (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphedema, breast cancer, stellate ganglion, treatment, ultrasound