Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)

NCT07102173 | Not Yet Recruiting

• 1 other identifier: 209/2024
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare two loco-regional analgesic techniques:

1. 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 intercostal spaces.
2. 2.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.

Conditions

Loco-regional Anesthesia

Keywords

VATS; post-operative analgesia; loco-regional anesthesia; ESPB; Intercostal nerve block

Outcome Measures

Primary Outcomes (1)

• QoR Score at Day 1

  From end surgery to Day 1 after surgery

Secondary Outcomes (1)

• Intraoperative NOL (Nociception Level Index®)

  From start to end surgery

Study Arms (2)

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.

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.

Procedure: Ultrasound-guided ESPB

Interventions

Intercostal nerve block PROCEDURE

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.

Intercostal nerve block

Ultrasound-guided ESPB PROCEDURE

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.

Ultrasound-guided ESPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• Signed informed consent
• Elective unilateral surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• ASST Sette Laghi: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE