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Completed

NCT Number: NCT03401801

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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