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

• Sponsor: Seoul National University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03401801
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 3
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain	Procedure: Stellate ganglion block	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 21, 2017
• Actual Primary Completion Date: Jul 21, 2018
• Actual Study Completion Date: Jul 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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).

5. 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).

6. 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.

7. 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.

8. 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.

9. Proportion of patients with ptosis [30 minutes after the block]

   Check the distance between upper lid margin and light reflex(MRD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.

• Responsible Party: Jeeyoun Moon, Clinical Associate Professor, Seoul National University
• ClinicalTrials.gov Identifier: NCT03401801
• Other Study ID Numbers: 1705-101-856
• First Posted: Jan 17, 2018
• Last Update Posted: Jun 25, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuralgia

Study Results

No Results Posted as of Jun 25, 2019