Effect of Erector Spinae Plane Block on Cerebral Oxygenation During One-Lung Ventilation
Evaluation of the Effect of Erector Spinae Plane Block on Cerebral Perfusion in Patients Undergoing One-Lung Ventilation in the Lateral Decubitus Position
1 other identifier
interventional
102
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of the erector spinae plane block, used to reduce postoperative pain, on cerebral oxygenation in thoracic surgery patients undergoing one-lung ventilation in the lateral decubitus position.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedFirst Submitted
Initial submission to the registry
January 14, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedFebruary 25, 2026
February 1, 2026
8 months
January 14, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in cerebral oxygen saturation (ΔrSO₂) during one-lung ventilation (OLV)
Cerebral oxygen saturation (rSO₂, %) will be measured using near-infrared spectroscopy (NIRS). ΔrSO₂ is defined as rSO₂ at each predefined intraoperative time point minus baseline rSO₂
Pre-intubation; intraoperatively at 0, 5, 10, 20, 30, and 60 minutes following intubation; and immediately before and after extubation
Secondary Outcomes (2)
Incidence of Right Cerebral Desaturation During OLV
Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation
Instantaneous remifentanil requirement during one-lung ventilation (OLV)
Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation
Study Arms (2)
Study Group
ACTIVE COMPARATORPatients who received a preoperative erector spinae plane block
Control Group
PLACEBO COMPARATORPatients who did not receive a preoperative erector spinae plane block
Interventions
In the study group, a single ultrasound-guided erector spinae plane block will be administered preoperatively using a total volume of 20 mL, consisting of 5 mL of 2% prilocaine hydrochloride, 10 mL of 0.5% bupivacaine, and 5 mL of 0.9% sodium chloride.
A preoperative erector spinae plane block will not be administered
Eligibility Criteria
You may qualify if:
- Patients aged 18-80 years
- With an American Society of Anesthesiologists (ASA) physical status of I-III
- Glasgow Coma Scale (GCS) score of 13-15
- Scheduled for thoracic surgery requiring one-lung ventilation
You may not qualify if:
- Patients undergoing emergency surgery
- Those younger than 18 years or older than 84 years
- Patients with an American Society of Anesthesiologists (ASA) physical status of IV or V
- Patients who refused to participate in the study
- Those with a history of brain surgery for any reason
- Patients with defects in the frontal region preventing placement of near-infrared spectroscopy probes
- Patients with distorted thoracic vertebral anatomy for any reason resulting in inadequate ultrasonographic imaging for block performance
- Patients with a known allergy to local anesthetics
- Patients with neurological disorders such as Alzheimer's disease or dementia
- Patients who were illiterate and/or unable to establish effective communication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kayseri City Hospital
Kayseri, Kocasinan/KAYSERİ, 38080, Turkey (Türkiye)
Related Publications (2)
Roberts ML, Lin HM, Tinuoye E, Cohen E, Flores RM, Fischer GW, Weiner MM. The Association of Cerebral Desaturation During One-Lung Ventilation and Postoperative Recovery: A Prospective Observational Cohort Study. J Cardiothorac Vasc Anesth. 2021 Feb;35(2):542-550. doi: 10.1053/j.jvca.2020.07.065. Epub 2020 Jul 27.
PMID: 32861541RESULTMukaihara K, Hasegawa-Moriyama M, Kanmura Y. Contralateral cerebral hemoglobin oxygen saturation changes in patients undergoing thoracotomy with general anesthesia with or without paravertebral block: a randomized controlled trial. J Anesth. 2017 Dec;31(6):829-836. doi: 10.1007/s00540-017-2402-7. Epub 2017 Aug 23.
PMID: 28836009RESULT
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Resident, Department of Anesthesiology
Study Record Dates
First Submitted
January 14, 2026
First Posted
February 25, 2026
Study Start
March 1, 2025
Primary Completion
October 30, 2025
Study Completion
October 30, 2025
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Individual participant data were not shared due to ethical and privacy considerations