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

NCT03401801 | Completed

• 1 other identifier: 1705-101-856
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Temperature changes(°C) in ipsilateral arm

  10 and 20 min after US-guided SGB

• Temperature changes in ipsilateral face

  10, 20, and 30 min after US-guided SGB

• Temperature changes in contralateral face

  10, 20, and 30 min after US-guided SGB

• Temperature changes in ipsilateral medial elbow

  10, 20, and 30 min after US-guided SGB

• Temperature changes in contralateral medial elbow

  10, 20, and 30 min after US-guided SGB

Study Arms (3)

4 ml of 1% lidocaine

ACTIVE COMPARATOR

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

6 ml of 1% lidocaine

ACTIVE COMPARATOR

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

8 ml of 1% lidocaine

ACTIVE COMPARATOR

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

Interventions

Stellate ganglion block PROCEDURE

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.

4 ml of 1% lidocaine; 6 ml of 1% lidocaine; 8 ml of 1% lidocaine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 85 years
• Patients with a new or known diagnosis of chronic neuropathic pain at the upper extremity or face.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 7577781 BACKGROUND

• 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.

  PMID: 11289093 BACKGROUND

• 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.

  PMID: 21490819 RESULT

• 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.

  PMID: 9613538 RESULT

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jee Youn Moon, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 17, 2018
• Study Start: November 21, 2017
• Primary Completion: July 21, 2018
• Study Completion: July 31, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)