Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Stellate ganglion block
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
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)
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
4 ml of 1% lidocaine
6 ml of 1% lidocaine
8 ml of 1% lidocaine
Arm Description
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: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Procedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Temperature changes in ipsilateral face
Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.
Temperature changes in contralateral face
Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.
Temperature changes in ipsilateral medial elbow
Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).
Temperature changes in contralateral medial elbow
Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).
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.
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.
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.
Proportion of patients with ptosis
Check the distance between upper lid margin and light reflex(MRD).
Full Information
NCT ID
NCT03401801
First Posted
January 4, 2018
Last Updated
June 23, 2019
Sponsor
Seoul National University
1. Study Identification
Unique Protocol Identification Number
NCT03401801
Brief Title
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
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
July 21, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 ml of 1% lidocaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
6 ml of 1% lidocaine
Arm Type
Active Comparator
Arm Description
Procedure: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Arm Title
8 ml of 1% lidocaine
Arm Type
Active Comparator
Arm Description
Procedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temperature change(°C) in ipsilateral arm
Description
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
Time Frame
thirty minute after US-guided SGB
Secondary Outcome Measure Information:
Title
Temperature changes(°C) in ipsilateral arm
Description
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
Time Frame
10 and 20 min after US-guided SGB
Title
Temperature changes in ipsilateral face
Description
Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.
Time Frame
10, 20, and 30 min after US-guided SGB
Title
Temperature changes in contralateral face
Description
Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.
Time Frame
10, 20, and 30 min after US-guided SGB
Title
Temperature changes in ipsilateral medial elbow
Description
Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).
Time Frame
10, 20, and 30 min after US-guided SGB
Title
Temperature changes in contralateral medial elbow
Description
Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).
Time Frame
10, 20, and 30 min after US-guided SGB
Title
Severity of pain using an 11-pointed numerical rating scale(NRS) pain score
Description
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 Frame
Time before block and time of block to 30 minutes after the block
Title
Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral arm compared to the contralateral arm
Description
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
Time Frame
30 minutes after the block
Title
Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral face compared to the contralateral face
Description
Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.
Time Frame
30 minutes after the block
Title
Proportion of patients with ptosis
Description
Check the distance between upper lid margin and light reflex(MRD).
Time Frame
30 minutes after the block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7577781
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.
Results Reference
background
PubMed Identifier
11289093
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.
Results Reference
background
PubMed Identifier
21490819
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.
Results Reference
result
PubMed Identifier
9613538
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.
Results Reference
result
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Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block
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