NCT07432230

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 14, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

Erector Spinae Plane BlockOne Lung VentilationNear İnfrared Spectroscopy

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 COMPARATOR

Patients who received a preoperative erector spinae plane block

Procedure: Erector Spinae Plane Block

Control Group

PLACEBO COMPARATOR

Patients who did not receive a preoperative erector spinae plane block

Procedure: A preoperative erector spinae plane block will not be administered

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.

Study Group

A preoperative erector spinae plane block will not be administered

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

  • Mukaihara 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.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective Randomized Controlled Study
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

Locations