Assessment of Diaphragmatic Function After Stellate Ganglion Block

NCT07722052 | Completed DMC

• 1 other identifier: 2024.442
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stellate Ganglion Block; Diaphragm Ultrasound; Hemidiaphragmatic Paralysis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (4)

• Forced vital capacity (FVC)

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

• Forced expiratory volume in 1 second (FEV1)

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

• Tiffeneau index (FEV1/FVC ratio)

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

• Peripheral oxygen saturation (SpO2)

  Measured at baseline and 1 hour after US-SGB.

Study Arms (1)

US-SGB

Patients with sympathetic nervous system-mediated disorders of the upper limb undergoing a first diagnostic ultrasound-guided stellate ganglion block (US-SGB).

Procedure: Ultrasound-guided stellate ganglion block

Interventions

Ultrasound-guided stellate ganglion block PROCEDURE

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

US-SGB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jose Manuel López González: lead

Study Sites (1)

FINBA

Oviedo, Principality of Asturias, 33001, Spain

Location

Related Publications (6)

• 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.

  PMID: 41035293 RESULT

• Santana 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.

  PMID: 33237154 RESULT

• Sferrazza 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.

  PMID: 27216909 RESULT

• Tsai 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.

  PMID: 41027820 RESULT

• Motazedian 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.

  PMID: 39433834 RESULT

• Kirkpatrick 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.

  PMID: 36949968 RESULT

Study Officials

• Daniel García Iglesias, MD, PhD

  Central University Hospital of Asturias, 33001, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD. Consultant Anesthesiologist and Pain Physician

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 23, 2026
• Study Start: December 1, 2024
• Primary Completion: December 10, 2025
• Study Completion: June 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

ES (1)