AzTrials
AzTrials

Neuropathic PainNCT03401801

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

A study testing Stellate ganglion block in people with Neuropathic Pain, run by Seoul National University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neuropathic Pain
What is being tested?
Stellate ganglion block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteSouth Korea
Study dates
21 Nov 2017to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.)
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Stellate ganglion block
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stellate ganglion blockProcedure or surgery

    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.

Study groups in NCT03401801
Study groupRoleWhat they receive
4 ml of 1% lidocaineActive comparatorProcedure: 4 ml of 1% lidocaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level.
Receives: Procedure: Stellate ganglion block
6 ml of 1% lidocaineActive comparatorProcedure: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Receives: Procedure: Stellate ganglion block
8 ml of 1% lidocaineActive comparatorProcedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
Receives: Procedure: Stellate ganglion block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: thirty minute after US-guided SGB

Secondary outcomes (9)

  1. 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.

    Measured: 10 and 20 min after US-guided SGB

  2. Temperature changes in ipsilateral face

    Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.

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

  3. Temperature changes in contralateral face

    Temperature is measured with a laser thermometer on a junction between the extended lines from pupil and nostril.

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

  4. Temperature changes in ipsilateral medial elbow

    Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).

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

  5. Temperature changes in contralateral medial elbow

    Temperature is measured with a laser thermometer on the forearm area (3 cm above the medial epicondyle).

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

  6. 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.

    Measured: Time before block and time of block to 30 minutes after the block

  7. 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.

    Measured: 30 minutes after the block

  8. 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.

    Measured: 30 minutes after the block

  9. Proportion of patients with ptosis

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

    Measured: 30 minutes after the block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start21 Nov 2017
  3. Primary completion21 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401801
Sponsor's protocol ID
1705-101-856
Status last verified
Jun 2019
First submitted
4 Jan 2018
Last updated
25 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 7577781

  • 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.

    PubMed 11289093

  • 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.

    PubMed 21490819

  • 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.

    PubMed 9613538

Questions about this trial

What is this clinical trial studying?

A study testing Stellate ganglion block in people with Neuropathic Pain, run by Seoul National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature change(°C) in ipsilateral arm (time frame: thirty minute after US-guided SGB). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03401801, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in