Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block

Study Overview
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Brief Summary
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The purpose of this study was to compare the temperature changes of the upper extremities when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided stellate ganglion block.

Detailed Description
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One pain physician performs all US-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4ml, 6ml, and 8ml of 1% lidocaine is injected for the each group, respectively. Syringes are prepared by one nurse who do not involved in other steps of this study. Temperature measurement is conducted 4 times (before US-guided SGB and after 10, 20, and 30m from SGB) at both hands, face, axillar by one person who's not involved in other measuring in the study.

Official Title
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Impact of Local Anesthetic Volume on Temperature Increase in the Upper Extremity During Ultrasound-guided Stellate Ganglion Block: A Prospective Randomized and Comparative Clinical Trial

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Procedure: Stellate ganglion block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 85 years Patients with a new or known diagnosis of chronic neuropathic pain at the upper extremity or face. Exclusion Criteria: Refusal of a patient Any vascular disease in the upper extremities (or face) Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis) Coagulopathy Systemic infection or local infection at the needle injection site Major deformation at the level of the neck (radiotherapy, surgery, etc.) Concomitant chronic pain syndrome at other sites. Post-pneumonectomy on the controlateral side Known allergy to local anesthetics of amide type Inability to understand a numeric rating pain scale (cognitive dysfunction)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4 ml of 1% lidocaine<br>Procedure: 4 ml of 1% lidocaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level. | Procedure: Stellate ganglion block<br>* Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4 ml, 6 ml, and 8 ml of 1% lidocaine is injected for the each group, respectively.<br>|
| Active Comparator: 6 ml of 1% lidocaine<br>Procedure: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level. | Procedure: Stellate ganglion block<br>* Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4 ml, 6 ml, and 8 ml of 1% lidocaine is injected for the each group, respectively.<br>|
| Active Comparator: 8 ml of 1% lidocaine<br>Procedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level. | Procedure: Stellate ganglion block<br>* Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4 ml, 6 ml, and 8 ml of 1% lidocaine is injected for the each group, respectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature change(°C) in ipsilateral arm | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. | thirty minute after US-guided SGB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature changes(°C) in ipsilateral arm | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. | 10 and 20 min after US-guided SGB | 
| Temperature changes in ipsilateral face | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. | 10, 20, and 30 min after US-guided SGB | 
| Temperature changes in contralateral face | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. | 10, 20, and 30 min after US-guided SGB | 
| Temperature changes in ipsilateral medial elbow | Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle). | 10, 20, and 30 min after US-guided SGB | 
| Temperature changes in contralateral medial elbow | Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle). | 10, 20, and 30 min after US-guided SGB | 
| Severity of pain using an 11-pointed numerical rating scale(NRS) pain score | The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., no pain) and 10 representing the other pain extreme (e.g., pain as bad as you can imagine and worst pain imaginable). The NRS will be administered verbally or graphically for self-completion. The respondent is asked to indicate the numeric value on the segmented scale that best describes their pain intensity. The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0-10. Higher scores indicate greater pain intensity. | Time before block and time of block to 30 minutes after the block | 
| Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral arm compared to the contralateral arm | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. | 30 minutes after the block | 
| Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral face compared to the contralateral face | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. | 30 minutes after the block | 
| Proportion of patients with ptosis | Check the distance between upper lid margin and light reflex(MRD). | 30 minutes after the block |