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

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ClinicalTrials.gov Identifier: NCT03401801
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : November 21, 2017
Actual Primary Completion Date : July 21, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Temperature change(°C) in ipsilateral arm [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 minutes after the block ]
    Check the distance between upper lid margin and light reflex(MRD).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03401801


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University
Investigators
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Study Director: Jee Youn Moon, MD, PhD Seoul National University Hospital

Publications of Results:
Other Publications:
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Responsible Party: Jeeyoun Moon, Clinical Associate Professor, Seoul National University
ClinicalTrials.gov Identifier: NCT03401801     History of Changes
Other Study ID Numbers: 1705-101-856
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action