Clinical trial NCT03401801: Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Temperature change(°C) in ipsilateral arm
timeFrame: thirty minute after US-guided SGB
Secondary outcomes:
measure: Temperature changes(°C) in ipsilateral arm
timeFrame: 10 and 20 min after US-guided SGB
measure: Temperature changes in ipsilateral face
timeFrame: 10, 20, and 30 min after US-guided SGB
measure: Temperature changes in contralateral face
timeFrame: 10, 20, and 30 min after US-guided SGB
measure: Temperature changes in ipsilateral medial elbow
timeFrame: 10, 20, and 30 min after US-guided SGB
measure: Temperature changes in contralateral medial elbow
timeFrame: 10, 20, and 30 min after US-guided SGB
measure: Severity of pain using an 11-pointed numerical rating scale(NRS) pain score
timeFrame: Time before block and time of block to 30 minutes after the block
measure: Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral arm compared to the contralateral arm
timeFrame: 30 minutes after the block
measure: Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral face compared to the contralateral face
timeFrame: 30 minutes after the block
measure: Proportion of patients with ptosis
timeFrame: 30 minutes after the block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kapral S, Krafft P, Gosch M, Fleischmann D, Weinstabl C. Ultrasound imaging for stellate ganglion block: direct visualization of puncture site and local anesthetic spread. A pilot study. Reg Anesth. 1995 Jul-Aug;20(4):323-8.
citation: Schurmann M, Gradl G, Wizgal I, Tutic M, Moser C, Azad S, Beyer A. Clinical and physiologic evaluation of stellate ganglion blockade for complex regional pain syndrome type I. Clin J Pain. 2001 Mar;17(1):94-100. doi: 10.1097/00002508-200103000-00012.
citation: Jung G, Kim BS, Shin KB, Park KB, Kim SY, Song SO. The optimal volume of 0.2% ropivacaine required for an ultrasound-guided stellate ganglion block. Korean J Anesthesiol. 2011 Mar;60(3):179-84. doi: 10.4097/kjae.2011.60.3.179. Epub 2011 Mar 30.
citation: Stevens RA, Stotz A, Kao TC, Powar M, Burgess S, Kleinman B. The relative increase in skin temperature after stellate ganglion block is predictive of a complete sympathectomy of the hand. Reg Anesth Pain Med. 1998 May-Jun;23(3):266-70. doi: 10.1016/s1098-7339(98)90053-0.