Comparison of Loco-regional Analgesic Techniques in Patients Undergoing Video Assisted Thoracoscopic Surgery (VATS)
NCT07102173 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2025-08-03
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 intercostal spaces.
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.
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.
Conditions
- Loco-regional Anesthesia
Interventions
- PROCEDURE
-
Intercostal nerve block
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
-
Ultrasound-guided ESPB
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.
Sponsors & Collaborators
-
ASST Sette Laghi
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2026-04-30
- Completion
- 2026-04-30
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