Loco-regional AnesthesiaPRoGEVATSNCT07102173
Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)
A study testing Intercostal nerve block and Ultrasound-guided ESPB in people with Loco-regional Anesthesia, run by ASST Sette Laghi.
Trial summary
This study aims to compare two loco-regional analgesic techniques: 1. Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loco-regional Anesthesia
- What is being tested?
- Intercostal nerve block and Ultrasound-guided ESPB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Signed informed consent
- Elective unilateral surgery
Who cannot join
- Minor patients
- BMI > 40
- Unstable neurological disorders
- Known allergy to acetaminophen and NSAIDs
- Chronic renal failure (stage > 4, whith GFR between 29 and 15 mL/min)
- Patient refusal
- Chronic use of NSAIDs and opioids in the 3 months prior to surgery
- Contraindications to peripheral block (infection al the insertion site, allergy to local anesthetics, severe coagulation disorders)
About this study
Official title: Management Protocol for Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)
This study aims to compare two loco-regional analgesic techniques:
- Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.
- Ultrasound-guided ESPB: Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
Read more
This protocol is intended for patients undergoing video-assisted thoracoscopic surgery (VATS) for pneumonectomies, lobectomies, wedge resections, and bullectomies.
Primary Endpoint:QoR Score at 24 hours (validated questionnaires. Secondary Endpoints: Intraoperative NOL, QoR at 48-72 hours, opioid consumption at 12-24-48 hours, NLR at 24 hours, CPSP incidence at 3 months.
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure that offers numerous advantages over traditional thoracotomy, including reduced surgical stress, lower postoperative pain, improved postoperative pulmonary function, reduced mortality, and shorter hospital stays.
Although VATS is less painful than open surgery, patients may still experience significant postoperative pain. Therefore, effective pain management is crucial to reducing postoperative complications and preventing acute postoperative pain from progressing to chronic pain.
Thoracic epidural analgesia and thoracic paravertebral blocks provide adequate pain control for thoracic surgery but may be associated with complications that can prolong hospital stays and increase morbidity.
Thus, recent trends favor less invasive regional analgesic techniques combined with systemic analgesia. Systemic analgesia follows a multimodal approach, incorporating intravenous medications such as acetaminophen, NSAIDs, lidocaine, and α2-adrenergic agonists.
Recent PROSPECT (PROcedure SPECific Postoperative Pain ManagemenT) guidelines recommend the erector spinae plane block (ESP) or paravertebral block (PVB) for postoperative analgesia following VATS.
Given the variety of available techniques, it is essential to determine the most effective analgesic strategy for postoperative pain management in VATS. Additionally, a standardized method for assessing both acute and chronic postoperative pain is necessary.
Furthermore, adopting an Enhanced Recovery After Surgery (ERAS) approach in thoracic surgery may be beneficial. ERAS is a perioperative care program involving multiple evidence-based interventions aimed at reducing surgical stress and accelerating patient recovery. Postoperative recovery is influenced by several factors, including the patient's general health status, anesthesia, and surgical techniques. One critical aspect of postoperative recovery assessment is the patient;s perception of their recovery quality, encompassing well-being, overall quality of life, and recovery from anesthesia. One of the most widely used tools for assessing perceived recovery quality is the Quality of Recovery-40 (QoR-40) questionnaire, developed by Myles in 2020. It evaluates five dimensions: pain, physical comfort, physical independence, emotional state, and psychological support. A shorter 15-item version (QoR-15) was later developed, which maintains good validity, reliability, and feasibility, as most patients can complete it in under three minutes.
Intraoperatively, technological advancements have led to the development of highly sophisticated analgesic monitoring tools. The Nociception Level Index (NOL®) is an innovative technology developed by Medasense Biometrics Ltd. that objectively measures nociception by analyzing multiple physiological parameters through artificial intelligence algorithms. A non-invasive fingertip probe with four sensors (photoplethysmography, galvanic skin response, peripheral temperature, and accelerometry) extracts multiple pain- related physiological signals. The algorithms analyze the data in real-time to identify the patient's pain patterns, translating them into a numerical scale. This device enables precise nociception monitoring in anesthetized patients, allowing for personalized analgesic treatment.
Postoperative pain remains a challenge in patients undergoing VATS, as inadequate acute pain control increases the risk of immediate complications and contributes to the development of chronic pain, leading to prolonged postoperative opioid use.
Balancing the efficacy of loco-regional analgesic techniques with their invasiveness and risk of procedural complications is essential. Recent literature suggests that both intraoperative intercostal nerve blocks and ultrasound-guided erector spinae plane blocks (ESPB) provide effective analgesia while being clinically safe and technically simple.
ESPB, in particular, allows anesthetic spread to both dorsal and ventral spinal nerve branches, covering approximately four dermatomes above and below the injection site.
Few comparative studies exist between these two techniques, indicating non-inferiority in terms of postoperative pain scores (NRS) and opioid consumption at 48 hours. However, further research is needed to assess intraoperative efficacy, postoperative complications, quality of recovery, and chronic pain development in patients receiving these techniques.
Chronic post-surgical pain (CPSP) is defined by the International Classification of Diseases (ICD-11) as \"pain that develops or increases in intensity following a surgical procedure and persists beyond the healing process for at least three months postoperatively; it is localized to the surgical area or the nerve distribution area in that region; other identifiable causes of pain must be excluded, and it may present with neuropathic characteristics.\" Given that CPSP affects 10%-50% of surgical patients, even a modest reduction in its prevalence could significantly improve many patients; quality of life. Inflammation plays a key role in acute pain generation and in mediating the transition from acute to chronic postoperative pain. The postoperative release of pro-inflammatory cytokines and chemokines contributes to peripheral and central sensitization, which are critical mechanisms underlying CPSP. Elevated absolute neutrophil counts, high neutrophil-to-lymphocyte ratio (NLR), or low absolute lymphocyte counts postoperatively have been associated with an increased risk of CPSP. A modified NLR ratio (postoperative/preoperative) ≥ 5 has been significantly correlated with CPSP in orthopedic procedures, shoulder arthroscopy, dental surgery, and laparoscopic cholecystectomy.
However, its correlation with CPSP in thoracic surgery remains unclear.
- Conditions
- Loco-regional Anesthesia
- Being tested
- Intercostal nerve block, Ultrasound-guided ESPB
- Keywords
- VATS, post-operative analgesia, loco-regional anesthesia, ESPB, Intercostal nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal nerve blockProcedure or surgery
Before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.
Ultrasound-guided ESPBProcedure or surgery
After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal nerve block | Active comparator | Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces. Receives: Procedure: Intercostal nerve block |
| Ultrasound-guided ESPB | Active comparator | Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered. Receives: Procedure: Ultrasound-guided ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR Score at Day 1
Measured: From end surgery to Day 1 after surgery
Secondary outcomes (1)
Intraoperative NOL (Nociception Level Index®)
NOL (Nociception Level) is the technology and index to objectively quantify a patient's physiological pain response (nociception). The Nociception Level index (NOL™) is a multiparameter index, based on artificial intelligence for the monitoring of nociception during anesthesia. We record the NOL number to assess nociceptive stimulation during surgery.
Measured: From start to end surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loco-regional AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASST Sette Laghi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Guzzetti, Ospedale di Circolo - Fondazione Macchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102173
- Sponsor's protocol ID
- 209/2024
- Acronym
- PRoGEVATS
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Protocol for Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT07102173
- Acronym / sponsor ID
- PRoGEVATS / 209/2024
- Conditions
- Loco-regional Anesthesia
- Keywords
- VATS, post-operative analgesia, loco-regional anesthesia, ESPB, Intercostal nerve block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- ASST Sette LaghiUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Aug 2025 (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.
This study aims to compare two loco-regional analgesic techniques:
- Intercostal nerve block: Performed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces.
- Ultrasound-guided ESPB: Performed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered.
This protocol is intended for patients undergoing video-assisted thoracoscopic surgery (VATS) for pneumonectomies, lobectomies, wedge resections, and bullectomies.
Primary Endpoint:QoR Score at 24 hours (validated questionnaires. Secondary Endpoints: Intraoperative NOL, QoR at 48-72 hours, opioid consumption at 12-24-48 hours, NLR at 24 hours, CPSP incidence at 3 months.
Detailed description
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure that offers numerous advantages over traditional thoracotomy, including reduced surgical stress, lower postoperative pain, improved postoperative pulmonary function, reduced mortality, and shorter hospital stays.
Although VATS is less painful than open surgery, patients may still experience significant postoperative pain. Therefore, effective pain management is crucial to reducing postoperative complications and preventing acute postoperative pain from progressing to chronic pain.
Thoracic epidural analgesia and thoracic paravertebral blocks provide adequate pain control for thoracic surgery but may be associated with complications that can prolong hospital stays and increase morbidity.
Thus, recent trends favor less invasive regional analgesic techniques combined with systemic analgesia. Systemic analgesia follows a multimodal approach, incorporating intravenous medications such as acetaminophen, NSAIDs, lidocaine, and α2-adrenergic agonists.
Recent PROSPECT (PROcedure SPECific Postoperative Pain ManagemenT) guidelines recommend the erector spinae plane block (ESP) or paravertebral block (PVB) for postoperative analgesia following VATS.
Given the variety of available techniques, it is essential to determine the most effective analgesic strategy for postoperative pain management in VATS. Additionally, a standardized method for assessing both acute and chronic postoperative pain is necessary.
Furthermore, adopting an Enhanced Recovery After Surgery (ERAS) approach in thoracic surgery may be beneficial. ERAS is a perioperative care program involving multiple evidence-based interventions aimed at reducing surgical stress and accelerating patient recovery. Postoperative recovery is influenced by several factors, including the patient's general health status, anesthesia, and surgical techniques. One critical aspect of postoperative recovery assessment is the patient;s perception of their recovery quality, encompassing well-being, overall quality of life, and recovery from anesthesia. One of the most widely used tools for assessing perceived recovery quality is the Quality of Recovery-40 (QoR-40) questionnaire, developed by Myles in 2020. It evaluates five dimensions: pain, physical comfort, physical independence, emotional state, and psychological support. A shorter 15-item version (QoR-15) was later developed, which maintains good validity, reliability, and feasibility, as most patients can complete it in under three minutes.
Intraoperatively, technological advancements have led to the development of highly sophisticated analgesic monitoring tools. The Nociception Level Index (NOL®) is an innovative technology developed by Medasense Biometrics Ltd. that objectively measures nociception by analyzing multiple physiological parameters through artificial intelligence algorithms. A non-invasive fingertip probe with four sensors (photoplethysmography, galvanic skin response, peripheral temperature, and accelerometry) extracts multiple pain- related physiological signals. The algorithms analyze the data in real-time to identify the patient's pain patterns, translating them into a numerical scale. This device enables precise nociception monitoring in anesthetized patients, allowing for personalized analgesic treatment.
Postoperative pain remains a challenge in patients undergoing VATS, as inadequate acute pain control increases the risk of immediate complications and contributes to the development of chronic pain, leading to prolonged postoperative opioid use.
Balancing the efficacy of loco-regional analgesic techniques with their invasiveness and risk of procedural complications is essential. Recent literature suggests that both intraoperative intercostal nerve blocks and ultrasound-guided erector spinae plane blocks (ESPB) provide effective analgesia while being clinically safe and technically simple.
ESPB, in particular, allows anesthetic spread to both dorsal and ventral spinal nerve branches, covering approximately four dermatomes above and below the injection site.
Few comparative studies exist between these two techniques, indicating non-inferiority in terms of postoperative pain scores (NRS) and opioid consumption at 48 hours. However, further research is needed to assess intraoperative efficacy, postoperative complications, quality of recovery, and chronic pain development in patients receiving these techniques.
Chronic post-surgical pain (CPSP) is defined by the International Classification of Diseases (ICD-11) as \"pain that develops or increases in intensity following a surgical procedure and persists beyond the healing process for at least three months postoperatively; it is localized to the surgical area or the nerve distribution area in that region; other identifiable causes of pain must be excluded, and it may present with neuropathic characteristics.\" Given that CPSP affects 10%-50% of surgical patients, even a modest reduction in its prevalence could significantly improve many patients; quality of life. Inflammation plays a key role in acute pain generation and in mediating the transition from acute to chronic postoperative pain. The postoperative release of pro-inflammatory cytokines and chemokines contributes to peripheral and central sensitization, which are critical mechanisms underlying CPSP. Elevated absolute neutrophil counts, high neutrophil-to-lymphocyte ratio (NLR), or low absolute lymphocyte counts postoperatively have been associated with an increased risk of CPSP. A modified NLR ratio (postoperative/preoperative) ≥ 5 has been significantly correlated with CPSP in orthopedic procedures, shoulder arthroscopy, dental surgery, and laparoscopic cholecystectomy.
However, its correlation with CPSP in thoracic surgery remains unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercostal nerve block | Active comparator | Procedure: Intercostal nerve blockPerformed by the surgeon intraoperatively before final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces. |
| Ultrasound-guided ESPB | Active comparator | Procedure: Ultrasound-guided ESPBPerformed by an anesthesiologist under surgical asepsis with the patient in a seated position. After identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients
- Signed informed consent
- Elective unilateral surgery
Key exclusion criteria (8 listed)
- Minor patients
- BMI > 40
- Unstable neurological disorders
- Known allergy to acetaminophen and NSAIDs
- Chronic renal failure (stage > 4, whith GFR between 29 and 15 mL/min)
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 |
|---|---|---|
| Intercostal nerve blockBefore final lung re-expansion, involving the administration of 20 mL of 0.5% levobupivacaine using a 27G needle into the subpleural space of the thoracotomy access site and adjacent intercostal spaces. | Procedure or surgery | Intercostal nerve block |
| Ultrasound-guided ESPBAfter identifying the target transverse process, a linear ultrasound probe is placed sagittally approximately 2 cm from the midline. The needle (22G, 50 mm) is inserted in-plane in a cranio-caudal direction until contacting the transverse process. After confirming proper injection by observing anesthetic spread between the erector spinae muscle and transverse process, a total of 30 mL of 0.375% ropivacaine is administered. | Procedure or surgery | Ultrasound-guided ESPB |
Primary outcome
QoR Score at Day 1
Time frame: From end surgery to Day 1 after surgery
1 secondary outcome
Intraoperative NOL (Nociception Level Index®)
Time frame: From start to end surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intercostal nerve block and Ultrasound-guided ESPB in people with Loco-regional Anesthesia, run by ASST Sette Laghi.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
QoR Score at Day 1 (time frame: From end surgery to Day 1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.