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

Seoul National University102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Neuropathic Pain

Interventions

Stellate ganglion blockPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: thirty minute after US-guided SGB

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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