Neuropathic Pain
Conditions
Brief summary
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
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.
Interventions
PROCEDUREStellate ganglion block
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.
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature change(°C) in ipsilateral arm | thirty minute after US-guided SGB | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temperature changes(°C) in ipsilateral arm | 10 and 20 min after US-guided SGB | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. |
| Temperature changes in ipsilateral face | 10, 20, and 30 min after US-guided SGB | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. |
| Temperature changes in contralateral face | 10, 20, and 30 min after US-guided SGB | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. |
| Temperature changes in ipsilateral medial elbow | 10, 20, and 30 min after US-guided SGB | Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle). |
| Temperature changes in contralateral medial elbow | 10, 20, and 30 min after US-guided SGB | Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle). |
| Severity of pain using an 11-pointed numerical rating scale(NRS) pain score | Time before block and time of block to 30 minutes after the block | 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. |
| Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral arm compared to the contralateral arm | 30 minutes after the block | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. |
| Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral face compared to the contralateral face | 30 minutes after the block | Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril. |
| Proportion of patients with ptosis | 30 minutes after the block | Check the distance between upper lid margin and light reflex(MRD). |
Countries
South Korea
Outcome results
None listed