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Completed

NCT Number: NCT07722052

Assessment of Diaphragmatic Function After Stellate Ganglion Block

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.

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Key information

Conditions

Stellate Ganglion Block Diaphragm Ultrasound Hemidiaphragmatic Paralysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FINBA

Oviedo, Principality of Asturias, 33001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Ultrasound-Guided Stellate Ganglion Block

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Forced vital capacity (FVC)

    Time frame: 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.

  2. Forced expiratory volume in 1 second (FEV1)

    Time frame: 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

  3. Tiffeneau index (FEV1/FVC ratio)

    Time frame: 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.

  4. Peripheral oxygen saturation (SpO2)

    Time frame: Measured at baseline and 1 hour after US-SGB.

    Peripheral blood oxygen saturation (SpO2) expressed in percentage (%), measured using a digital pulse oximeter.

Sponsors and collaborators

Lead sponsor

Jose Manuel López González

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

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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