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NCT Number: NCT07182695

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

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.

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Key information

Conditions

Acute Respiratory Failure (ARF) Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Primary outcomes

  1. Change in Dyspnea by Visual Analog Scale (D-VAS)

    Time frame: 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 outcomes

  1. Respiratory Distress Observation Scale (RDOS) Score

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    Observer-rated RDOS (higher scores indicate more severe respiratory distress); standard scoring per instrument.

  2. Intensive Care Respiratory Distress Observation Scale (IC-RDOS) Score

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    Observer-rated IC-RDOS (higher scores worse); standard scoring per instrument.

  3. Diaphragm Excursion Amplitude on Ultrasound

    Time frame: Baseline (pre-block), 30 minutes

    Peak-to-peak diaphragm excursion amplitude measured bilaterally with bedside ultrasound/M-mode.

  4. Arterial Blood Gas Parameters: pH, PaO₂, PaCO₂ , SaO₂, HCO₃-

    Time frame: Baseline (pre-block), 30 minutes, 8 hours, 16 hours, and 24 hours after the ESP block.

    Abstracted from ABGs

  5. Adverse Events Related to ESP Block

    Time frame: From block through 24 hours.

    Number of participants with any block-related AE within 24 hours, per chart review/clinical documentation.

  6. Respiratory Rate (Breaths/minute)

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    Respiratory Rate recorded per routine monitoring.

  7. Heart Rate (Beats/minute)

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    Heart rate recorded per routine monitoring.

  8. SpO₂ (%)

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    SpO₂ recorded per routine monitoring.

  9. Blood Pressure (mm-Hg)

    Time frame: Baseline, 30 minutes, 8 hours, 16 hours, 24 hours post-block.

    Blood Pressure recorded per routine monitoring.

Study contacts

Contact information is provided by the study sponsor or research team.

Çağrı Arslan, Resident

CONTACT

[email protected]

+90 551 722 26 60

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

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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