Assessment of Diaphragmatic Function After Stellate Ganglion Block

N/ACompletedNCT07722052

Jose Manuel López González15 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Stellate Ganglion Block Diaphragm Ultrasound Hemidiaphragmatic Paralysis

Interventions

Ultrasound-guided stellate ganglion blockPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

FINBA

Oviedo, Principality of Asturias, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: The diaphragmatic thickening, assessed by diaphragm ultrasound before and 30 minutes after US-SGB.

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: Spirometric parameters measured at baseline and 1 hour after US-SGB.

Data from ClinicalTrials.gov

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