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One Lung Ventillation (OLV)NCT07432230

Effect of Erector Spinae Plane Block on Cerebral Oxygenation During One-Lung Ventilation

A study testing Erector Spinae Plane Block and A preoperative erector spinae plane block will not be administered in people with One Lung Ventillation (OLV) and Erector Spina Plan Block, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Erector Spinae Plane Block and A preoperative erector spinae plane block will not be administered
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kayseri City Hospital

    Kayseri, Kocasinan/KAYSERİ, 38080

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Erector Spinae Plane Block on Cerebral Perfusion in Patients Undergoing One-Lung Ventilation in the Lateral Decubitus Position

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.

Read the detailed description

Pulmonary resection is one of the most frequently performed procedures in thoracic surgery. Lung resections are primarily carried out for the diagnosis and treatment of pulmonary malignancies and, less commonly, for the management of pulmonary bullae, bronchiectasis, complicated infectious lung diseases, and traumatic lung injuries.

During surgery, patients are placed in the lateral decubitus position, and one-lung ventilation (OLV) is employed during both open and endoscopic thoracic procedures to restrict lung movement and to improve surgical exposure and operative conditions.

Thoracotomy is considered one of the most painful surgical procedures in thoracic surgery. It is well established that inadequately controlled intraoperative and postoperative pain adversely affects functional recovery. Despite the use of potent analgesics, patients may experience severe postoperative pain. Consequently, significant hemodynamic instability may occur even under general anesthesia during thoracotomy. In addition, pain may impair respiratory mechanics, leading to atelectasis and other postoperative pulmonary complications.

In the erector spinae plane block (ESPB), anatomical landmarks are identified under ultrasound guidance, and a local anesthetic is administered beneath the erector spinae muscle at the level just above the transverse process of the vertebra, providing thoracic anesthesia. ESPB is frequently used to provide postoperative analgesia in patients undergoing pulmonary surgery in thoracic practice.

It is well recognized that ESPB offers several advantages over traditional techniques performed close to the neuraxis. First, the target structure is easily visualized with ultrasound, and needle advancement toward the target is relatively simple, making the technique easy to perform. In addition, the complication rate associated with this block is relatively low. Critical structures that may result in serious complications if injured-such as the pleura, vascular structures, and the spinal cord-are located away from the needle trajectory. Considering its technical simplicity and relative safety, several authors have suggested that ESPB may be incorporated as a component of multimodal analgesia during the perioperative period.

In anesthesiology and critical care practice, pulse oximetry is the most commonly used standard method for assessing oxygenation. In pulse oximetry, a probe is typically placed on the distal extremities to measure oxygen-saturated hemoglobin levels. However, in conditions predisposed to hypoxemia-such as one-lung ventilation, cardiac surgery, or hypotensive anesthesia-pulse oximetry may be insufficient for accurately reflecting cerebral oxygenation. Therefore, cerebral oximeters have been specifically designed to assess cerebral oxygenation. Near-infrared spectroscopy (NIRS) reliably reflects changes in cerebral oxygenation. rSO₂ index values obtained during periods of hypercapnia, hypocapnia, hypoxemia, and arterial hypotension provide valuable information regarding cerebral oxygenation status.

NIRS is a noninvasive optical technique used to assess tissue oxygenation and was first introduced by Jobsis in 1977 . Similar to pulse oximetry, NIRS utilizes light wavelengths between 700 and 1000 nm and measures the difference between oxyhemoglobin and deoxyhemoglobin through transcutaneous probes, thereby reflecting oxygen uptake in the underlying tissue. This measurement is interpreted as regional oxygen saturation (rSO₂).

Since venous blood volume in the frontal region of the brain accounts for approximately 70-75% of total cerebral blood volume, monitoring this region is considered meaningful for the assessment of cerebral oxygenation. Studies investigating NIRS have demonstrated a significant reduction in oxygenation of the prefrontal cortex-an area critical for higher-order and central cognitive functions-during hypoxic exposure.

A cerebral rSO₂ value below 50% or a reduction greater than 20% from baseline has been associated with postoperative cognitive dysfunction and prolonged hospital stays. Furthermore, cerebral oxygen desaturation episodes have been shown to be associated with postoperative neurocognitive dysfunction, and monitoring and treating these episodes may reduce the incidence of postoperative neurocognitive impairment.

Using the NIRS technique, regional cerebral tissue oxygen saturation can be assessed continuously during the intraoperative period. When rSO₂ values fall below critical thresholds, clinicians are alerted, allowing corrective interventions to be implemented to ensure adequate cerebral oxygenation.

During thoracic surgery, the use of OLV and the lateral decubitus position leads to multiple changes in oxygenation, ventilation, and overall physiology. Even when effective hypoxic pulmonary vasoconstriction occurs to improve oxygenation during OLV, intrapulmonary shunting still develops, resulting in alterations in systemic oxygenation and hypoxia. Therefore, close monitoring of oxygenation and ventilation during OLV is of vital importance in thoracic anesthesia.

The primary aim of this study is to evaluate the effect of preoperatively administered ESPB on intraoperative NIRS values. The secondary aim is to compare hemodynamic parameters and intraoperative remifentanil requirements between patients

Being tested
Erector Spinae Plane Block, A preoperative erector spinae plane block will not be administered
Keywords
Erector Spinae Plane Block, One Lung Ventilation, Near İnfrared Spectroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane BlockProcedure or surgery

    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 administeredProcedure or surgery

    A preoperative erector spinae plane block will not be administered

Study groups in NCT07432230
Study groupRoleWhat they receive
Study GroupActive comparatorPatients who received a preoperative erector spinae plane block
Receives: Procedure: Erector Spinae Plane Block
Control GroupPlacebo comparatorPatients who did not receive a preoperative erector spinae plane block
Receives: Procedure: A preoperative erector spinae plane block will not be administered

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Pre-intubation; intraoperatively at 0, 5, 10, 20, 30, and 60 minutes following intubation; and immediately before and after extubation

Secondary outcomes (2)
  1. Incidence of Right Cerebral Desaturation During OLV

    Cerebral desaturation is defined as a ≥20% decrease from baseline rSO₂-R/L and/or an absolute rSO₂-R/L value <50%, measured by NIRS.

    Measured: Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation

  2. Instantaneous remifentanil requirement during one-lung ventilation (OLV)

    Instantaneous remifentanil requirement is defined as the remifentanil infusion rate at the time of each predefined intraoperative assessment during OLV, recorded from the anesthesia infusion system, and expressed in mcg/min

    Measured: Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start1 Mar 2025
  3. Primary completion30 Oct 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective Randomized Controlled Study
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07432230
Sponsor's protocol ID
2025-KAEK-038
Status last verified
Feb 2026
First submitted
14 Jan 2026
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data were not shared due to ethical and privacy considerations

Publications

  • 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.

    PubMed 32861541
  • 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.

    PubMed 28836009

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane Block and A preoperative erector spinae plane block will not be administered in people with One Lung Ventillation (OLV) and Erector Spina Plan Block, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in cerebral oxygen saturation (ΔrSO₂) during one-lung ventilation (OLV) (time frame: Pre-intubation; intraoperatively at 0, 5, 10, 20, 30, and 60 minutes following intubation; and immediately before and after extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07432230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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