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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorASST Sette Laghi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients

Signed informed consent

Elective unilateral surgery

Disqualifiers

Minor patients

BMI > 40

Unstable neurological disorders

Known allergy to acetaminophen and NSAIDs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intercostal nerve block

    Procedure/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 ESPB

    Procedure/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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Intercostal nerve blockActive comparator 1 intervention
Group B: Ultrasound-guided ESPBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

QoR Score at Day 1

Time frame
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.

Time frame
From start to end surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ASST Sette Laghi

Lead sponsor

Ospedale di Circolo - Fondazione Macchi

Sponsor institution

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