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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4 ml of 1% lidocaine; 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; 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.
Active Comparator: 6 ml of 1% lidocaine; 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; 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.
Active Comparator: 8 ml of 1% lidocaine; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Study Director: Jee Youn Moon, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): July 21, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 1705-101-856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No