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

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401801
• Other study ID #: 1705-101-856
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2019
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 31, 2018
• Est. primary completion date: July 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Procedure:
• Stellate 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View Citation

Schürmann 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients with ptosis	Check the distance between upper lid margin and light reflex(MRD).	30 minutes after the block