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).
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
- Conditions the study is for
- One Lung Ventillation (OLV), Erector Spina Plan Block, Near Infrared Spectroscopy
- 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
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
- Conditions
- One Lung Ventillation (OLV), Erector Spina Plan Block, Near Infrared Spectroscopy, Cerebral Desaturation, Intraoperative Analgesic Use
- 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 group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Patients who received a preoperative erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
| Control Group | Placebo comparator | Patients 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.
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)
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
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.
- First posted25 Feb 2026
- Study start1 Mar 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for One Lung Ventillation (OLV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ferhunde Yalçın Akçakaya, Kayseri City Hospital
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 32861541Mukaihara 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07432230
- Acronym / sponsor ID
- 2025-KAEK-038
- Conditions
- One Lung Ventillation (OLV), Erector Spina Plan Block, Near Infrared Spectroscopy, Cerebral Desaturation, Intraoperative Analgesic Use
- Keywords
- Erector Spinae Plane Block, One Lung Ventilation, Near İnfrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Procedure: Erector Spinae Plane BlockPatients who received a preoperative erector spinae plane block |
| Control Group | Placebo comparator | Procedure: A preoperative erector spinae plane block will not be administeredPatients who did not receive a preoperative erector spinae plane block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockIn 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. | Procedure or surgery | Study Group |
| A preoperative erector spinae plane block will not be administeredA preoperative erector spinae plane block will not be administered | Procedure or surgery | Control Group |
Primary outcome
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
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
2 secondary outcomes
Incidence of Right Cerebral Desaturation During OLV
Time frame: 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)
Time frame: Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Results publication: PubMed 32861541Roberts 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.
- Results publication: PubMed 28836009Mukaihara 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.
- Evaluation of Cerebral Oxygenation During One-lung Ventilation in Diabetic Patients Undergoing Lung Resection: A Prospective and Observational StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data were not shared due to ethical and privacy considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.