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Assessment of Diaphragmatic Function After Stellate Ganglion Block

Diaphragmatic Ultrasound and Spirometry After Ultrasound-guided Stellate Ganglion Block: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07722052
Enrollment
15
Registered
2026-07-23
Start date
2024-12-01
Completion date
2026-06-01
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragm Ultrasound, Hemidiaphragmatic Paralysis, Stellate Ganglion Block

Keywords

stellate ganglion block, diaphragm ultrasound, hemidiaphragmatic paralysis, diaphragmatic excursion, diaphragmatic thickening fraction, spirometry

Brief 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.

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.

Interventions

US-SGB was performed at the C7 level using 10 ml of 0.25% levobupivacaíne.

Sponsors

Jose Manuel López González
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients over 18 years of age. * patients with sympathetic nervous system-mediated disorders.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic excursionThe 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 fractionThe 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.

Secondary

MeasureTime frameDescription
Forced vital capacity (FVC)Spirometric parameters measured at baseline and 1 hour after US-SGB.Measure of the maximum exhaled volume of air (in liters, L) after a deep breath, on spirometry performed using a pneumotachograph spirometer.
Forced expiratory volume in 1 second (FEV1)Spirometric parameters measured at baseline and 1 hour after US-SGB.Measure of the exhaled air volume (in liters, L) in the first second of the spirometry, performed using a pneumotachograph spirometer
Tiffeneau index (FEV1/FVC ratio)Spirometric parameters measured at baseline and 1 hour after US-SGB.Ratio between the aforementioned FEV1 and FVC expressed in percentage (%), derived from the parameters obtained on spirometry.
Peripheral oxygen saturation (SpO2)Measured at baseline and 1 hour after US-SGB.Peripheral blood oxygen saturation (SpO2) expressed in percentage (%), measured using a digital pulse oximeter.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORDaniel García Iglesias, MD, PhD

Central University Hospital of Asturias, 33001, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026