Stellate Ganglion BlockNCT07722052
Assessment of Diaphragmatic Function After Stellate Ganglion Block
An observational study of Stellate Ganglion Block and Diaphragm Ultrasound, run by Jose Manuel López González at 1 site in Spain.
Trial summary
The objective of our study was to evaluate the incidence of hemidiaphragmatic paralysis after ultrasound-guided stellate ganglion block (US-SGB) by assessing diaphragmatic excursion and diaphragmatic thickening fraction using diaphragm ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stellate Ganglion Block, Diaphragm Ultrasound, Hemidiaphragmatic Paralysis
- What is being tested?
- Ultrasound-guided stellate ganglion block
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 1 Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: After approval of the study by the Principality of Asturias Drug Research Ethics Committee (CEImPA), Spain, and obtaining informed consent from the participants, all consecutive patients undergoing a first diagnostic US-SGB for sympathetic nervous system-mediated disorders were prospectively included.
Who may be able to join
- patients over 18 years of age.
- patients with sympathetic nervous system-mediated disorders.
Who cannot join
- patients younger than 18 years of age.
- patients with severe chronic obstructive pulmonary disease.
- previous diaphragmatic paralysis or neuromuscular disease.
- inability to undergo diaphragmatic ultrasound.
- patients with neck anatomy considered unsuitable for the procedure (including previous neck surgery, burns, extensive scarring or large goiters resulting in distortion of normal cervical anatomy).
- contraindications to the interventional technique (such as infection at the puncture site, or refusal to provide consent).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragmatic Ultrasound and Spirometry After Ultrasound-guided Stellate Ganglion Block: a Prospective Observational Study
The objective of our study was to evaluate the incidence of hemidiaphragmatic paralysis after ultrasound-guided stellate ganglion block (US-SGB) by assessing diaphragmatic excursion and diaphragmatic thickening fraction using diaphragm ultrasound.
Read the detailed description
A prospective, single-center observational study was designed with the aim of evaluating diaphragmatic excursion and diaphragmatic thickening fraction, measured by ultrasound before and 30 minutes after US-SGB performed with 10 mL of 0.25% levobupivacaíne.
- Being tested
- Ultrasound-guided stellate ganglion block
- Keywords
- stellate ganglion block, diaphragm ultrasound, hemidiaphragmatic paralysis, diaphragmatic excursion, diaphragmatic thickening fraction, spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided stellate ganglion blockProcedure or surgery
US-SGB was performed at the C7 level using 10 ml of 0.25% levobupivacaíne.
| Study group | Role | What they receive |
|---|---|---|
| US-SGB | Patients with sympathetic nervous system-mediated disorders of the upper limb undergoing a first diagnostic ultrasound-guided stellate ganglion block (US-SGB). Receives: Procedure: Ultrasound-guided stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic excursion
Excursion of the diaphragmatic dome was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Once the dome was identified, excursion was measured in M-mode as the distance, in centimeters, between the end-expiratory and end-inspiratory positions during a vital capacity manoeuvre.
Measured: The diaphragmatic excursion, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.
Diaphragmatic thickening fraction
The diaphragmatic thickening fraction was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Diaphragm thickness was measured, in centimeters, at end-inspiration and end-expiration during a vital capacity manoeuvre. Thickening fraction was calculated using the following formula and expressed as a percentaje:
Thickening fraction = [(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration] x 100.
Measured: The diaphragmatic thickening, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.
Secondary outcomes (4)
Forced vital capacity (FVC)
Measure of the maximum exhaled volume of air (in liters, L) after a deep breath, on spirometry performed using a pneumotachograph spirometer.
Measured: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Forced expiratory volume in 1 second (FEV1)
Measure of the exhaled air volume (in liters, L) in the first second of the spirometry, performed using a pneumotachograph spirometer
Measured: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Tiffeneau index (FEV1/FVC ratio)
Ratio between the aforementioned FEV1 and FVC expressed in percentage (%), derived from the parameters obtained on spirometry.
Measured: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Peripheral oxygen saturation (SpO2)
Peripheral blood oxygen saturation (SpO2) expressed in percentage (%), measured using a digital pulse oximeter.
Measured: Measured at baseline and 1 hour after US-SGB.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Dec 2024
- Primary completion10 Dec 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jose Manuel López González
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Manuel López González, Fundación para la Investigación Biosanitaria del Principado de Asturias
- Investigators
- Daniel García Iglesias, MD, PhD, Principal investigator, Central University Hospital of Asturias, 33001, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722052
- Sponsor's protocol ID
- 2024.442
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rafla C, Zitek T, Shalaby M. A systematic review of the respiratory effects of ultrasound-guided phrenic nerve block. Anesth Pain Med (Seoul). 2025 Oct;20(4):371-383. doi: 10.17085/apm.25214. Epub 2025 Sep 26.
PubMed 41035293Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
PubMed 33237154Sferrazza Papa GF, Pellegrino GM, Di Marco F, Imeri G, Brochard L, Goligher E, Centanni S. A Review of the Ultrasound Assessment of Diaphragmatic Function in Clinical Practice. Respiration. 2016;91(5):403-11. doi: 10.1159/000446518. Epub 2016 May 25.
PubMed 27216909Tsai EH, Nunez-Rodriguez E, Cata JP. Stellate ganglion block in perioperative practice: a narrative review. Br J Anaesth. 2026 Jan;136(1):179-196. doi: 10.1016/j.bja.2025.07.095. Epub 2025 Sep 29.
PubMed 41027820Motazedian P, Quinn N, Wells GA, Beauregard N, Lam E, Mathieu ME, Knoll W, Prosperi-Porta G, Ly V, Parlow S, Di Santo P, Abdel-Razek O, Jung R, Simard T, Jentzer JC, Mathew R, Ramirez FD, Hibbert B. Efficacy of stellate ganglion block in treatment of electrical storm: a systematic review and meta-analysis. Sci Rep. 2024 Oct 21;14(1):24719. doi: 10.1038/s41598-024-76663-9.
PubMed 39433834Kirkpatrick K, Khan MH, Deng Y, Shah KB. A Review of Stellate Ganglion Block as an Adjunctive Treatment Modality. Cureus. 2023 Feb 19;15(2):e35174. doi: 10.7759/cureus.35174. eCollection 2023 Feb.
PubMed 36949968
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Ultrasound and Spirometry After Ultrasound-guided Stellate Ganglion Block: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07722052
- Acronym / sponsor ID
- 2024.442
- Keywords
- stellate ganglion block, diaphragm ultrasound, hemidiaphragmatic paralysis, diaphragmatic excursion, diaphragmatic thickening fraction, spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jose Manuel López GonzálezUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of our study was to evaluate the incidence of hemidiaphragmatic paralysis after ultrasound-guided stellate ganglion block (US-SGB) by assessing diaphragmatic excursion and diaphragmatic thickening fraction using diaphragm ultrasound.
Detailed description
A prospective, single-center observational study was designed with the aim of evaluating diaphragmatic excursion and diaphragmatic thickening fraction, measured by ultrasound before and 30 minutes after US-SGB performed with 10 mL of 0.25% levobupivacaíne.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US-SGB | – | Procedure: Ultrasound-guided stellate ganglion blockPatients with sympathetic nervous system-mediated disorders of the upper limb undergoing a first diagnostic ultrasound-guided stellate ganglion block (US-SGB). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- After approval of the study by the Principality of Asturias Drug Research Ethics Committee (CEImPA), Spain, and obtaining informed consent from the participants, all consecutive patients undergoing a first diagnostic US-SGB for sympathetic nervous system-mediated disorders were prospectively included.
Key inclusion criteria (2 listed)
- patients over 18 years of age.
- patients with sympathetic nervous system-mediated disorders.
Key exclusion criteria (6 listed)
- patients younger than 18 years of age.
- patients with severe chronic obstructive pulmonary disease.
- previous diaphragmatic paralysis or neuromuscular disease.
- inability to undergo diaphragmatic ultrasound.
- patients with neck anatomy considered unsuitable for the procedure (including previous neck surgery, burns, extensive scarring or large goiters resulting in distortion of normal cervical anatomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided stellate ganglion blockUS-SGB was performed at the C7 level using 10 ml of 0.25% levobupivacaíne. | Procedure or surgery | US-SGB |
Primary outcome
Diaphragmatic excursion
Time frame: The diaphragmatic excursion, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.
Excursion of the diaphragmatic dome was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Once the dome was identified, excursion was measured in M-mode as the distance, in centimeters, between the end-expiratory and end-inspiratory positions during a vital capacity manoeuvre.
Diaphragmatic thickening fraction
Time frame: The diaphragmatic thickening, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.
The diaphragmatic thickening fraction was assessed by a pulmonologist experienced in diaphragm ultrasound assessment. Diaphragm thickness was measured, in centimeters, at end-inspiration and end-expiration during a vital capacity manoeuvre. Thickening fraction was calculated using the following formula and expressed as a percentaje: Thickening fraction = [(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration] x 100.
4 secondary outcomes
Forced vital capacity (FVC)
Time frame: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Forced expiratory volume in 1 second (FEV1)
Time frame: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Tiffeneau index (FEV1/FVC ratio)
Time frame: Spirometric parameters measured at baseline and 1 hour after US-SGB.
Peripheral oxygen saturation (SpO2)
Time frame: Measured at baseline and 1 hour after US-SGB.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publication: PubMed 41035293Rafla C, Zitek T, Shalaby M. A systematic review of the respiratory effects of ultrasound-guided phrenic nerve block. Anesth Pain Med (Seoul). 2025 Oct;20(4):371-383. doi: 10.17085/apm.25214. Epub 2025 Sep 26.
- Results publication: PubMed 33237154Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.
- Results publication: PubMed 27216909Sferrazza Papa GF, Pellegrino GM, Di Marco F, Imeri G, Brochard L, Goligher E, Centanni S. A Review of the Ultrasound Assessment of Diaphragmatic Function in Clinical Practice. Respiration. 2016;91(5):403-11. doi: 10.1159/000446518. Epub 2016 May 25.
- Results publication: PubMed 41027820Tsai EH, Nunez-Rodriguez E, Cata JP. Stellate ganglion block in perioperative practice: a narrative review. Br J Anaesth. 2026 Jan;136(1):179-196. doi: 10.1016/j.bja.2025.07.095. Epub 2025 Sep 29.
- Results publication: PubMed 39433834Motazedian P, Quinn N, Wells GA, Beauregard N, Lam E, Mathieu ME, Knoll W, Prosperi-Porta G, Ly V, Parlow S, Di Santo P, Abdel-Razek O, Jung R, Simard T, Jentzer JC, Mathew R, Ramirez FD, Hibbert B. Efficacy of stellate ganglion block in treatment of electrical storm: a systematic review and meta-analysis. Sci Rep. 2024 Oct 21;14(1):24719. doi: 10.1038/s41598-024-76663-9.
- Results publication: PubMed 36949968Kirkpatrick K, Khan MH, Deng Y, Shah KB. A Review of Stellate Ganglion Block as an Adjunctive Treatment Modality. Cureus. 2023 Feb 19;15(2):e35174. doi: 10.7759/cureus.35174. eCollection 2023 Feb.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel García Iglesias, MD, PhD principal investigator
Central University Hospital of Asturias, 33001, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stellate Ganglion Block and Diaphragm Ultrasound, run by Jose Manuel López González at 1 site in Spain.
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 6 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 23 Jul 2026. 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 Spain. 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?
Diaphragmatic excursion (time frame: The diaphragmatic excursion, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.). The study lists 2 primary outcomes in all. 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 NCT07722052, which also lists 6 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 23 Jul 2026.