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Cervical Erector Spinae Plane Block for Dyspnea in Acute Respiratory Failure: A Prospective Cohort

Effect of Bilateral Cervical Erector Spinae Plane Block on Dyspnea in Patients With Acute Respiratory Failure: A Prospective Single-Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07182695
Enrollment
30
Registered
2025-09-19
Start date
2025-09-15
Completion date
2026-03-15
Last updated
2025-09-19

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

Conditions

Acute Respiratory Failure (ARF), Dyspnea

Keywords

Cervical ESP block, Diaphragm ultrasound, Intensive care, Ultrasound-guided regional anesthesia

Brief summary

Dyspnea is common and distressing in patients with acute respiratory failure. In our intensive care unit, some patients receive a cervical erector spinae plane (ESP) block to help relieve dyspnea. This study will observe patients who receive bilateral cervical ESP blocks and measure changes in dyspnea using validated scales at predefined time points over 24 hours. We will also track vital signs, arterial blood gas values, and diaphragm movement on ultrasound.

Detailed description

Prospective, single-cohort observational study in an adult ICU. Consecutive eligible patients with acute respiratory failure who receive bilateral cervical ESP block will be enrolled. Dyspnea severity will be measured using a 100-mm Dyspnea Visual Analog Scale (D-VAS), the Respiratory Distress Observation Scale (RDOS), and the Intensive Care RDOS (IC-RDOS) before the block (baseline) and at 30 minutes, 8 hours, 16 hours, and 24 hours after the block. Vital signs (respiratory rate, heart rate, peripheral oxygen saturation, blood pressure) will be recorded at the same time points. From arterial blood gases, pH, PaO₂, PaCO₂, SaO₂, and HCO₃- will be abstracted. Bilateral diaphragm excursion amplitude will be measured with bedside ultrasound. Statistical plan includes normality checks; repeated-measures ANOVA for parametric data or Friedman test for nonparametric data; paired t-test or Wilcoxon as needed; chi-square or Fisher's exact for categorical variables. Planned sample size: 30 (power analysis for repeated measures with effect size 0.25, α=0.05, power=0.90).

Interventions

None listed

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* ICU admission with acute respiratory failure. * Patient or legally authorized representative provides consent. * Cervical ESP block performed for dyspnea treatment

Exclusion criteria

* Infection at block site. * Known diaphragm paralysis. * Known allergy to local anesthetics. * Refusal of consent (patient or representative).

Design outcomes

Primary

MeasureTime frameDescription
Change in Dyspnea by Visual Analog Scale (D-VAS)Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.Patient-reported dyspnea on a 100-mm line (0=no dyspnea, 100=worst imaginable); measured in mm from 0 anchor to the patient's mark.

Secondary

MeasureTime frameDescription
Intensive Care Respiratory Distress Observation Scale (IC-RDOS) ScoreBaseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.Observer-rated IC-RDOS (higher scores worse); standard scoring per instrument.
Diaphragm Excursion Amplitude on UltrasoundBaseline (pre-block), 30 minutesPeak-to-peak diaphragm excursion amplitude measured bilaterally with bedside ultrasound/M-mode.
Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃-Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.Abstracted from ABGs
Adverse Events Related to ESP BlockFrom block through 24 hours.Number of participants with any block-related AE within 24 hours, per chart review/clinical documentation.
Respiratory Distress Observation Scale (RDOS) ScoreBaseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.Observer-rated RDOS (higher scores indicate more severe respiratory distress); standard scoring per instrument.
Heart Rate (Beats/minute)Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.Heart rate recorded per routine monitoring.
SpO₂ (%)Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.SpO₂ recorded per routine monitoring.
Blood Pressure (mm-Hg)Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.Blood Pressure recorded per routine monitoring.
Respiratory Rate (Breaths/minute)Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.Respiratory Rate recorded per routine monitoring.

Contacts

Primary ContactÇağrı Arslan, Resident
cagriarslan96@gmail.com+90 551 722 26 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026