Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections.

IRCCS Sacro Cuore Don Calabria di Negrar7 enrolled

Overview

A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection

A prospective randomized trial which aims to evaluate a new technique of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing minimally invasive lung resection in spontaneous breathing, with intravenous sedation ("non-intubated thoracic surgery"). ESPB will be compared with a largely employed procedure for loco regional pain management: the Paravertebral block (PB). Both procedures are performed under ultrasonographic guidance to allow proper visualization of the target site. Surgery is carried out by means of a minimally invasive approach (Video Assisted thoracic Surgery) with two keyhole incisions on the affected side.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lung Neoplasms

Interventions

Paravertebral Block (PVB)PROCEDURE

PVB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%) in the paravertebral space (defined by the anterior aspect of the ribs, the vertebral body and the parietal pleura. The space is identified under ultrasonographic guidance by a dedicated Anesthesiologist.

Erector Spinae Plane Block (ESPB)PROCEDURE

ESPB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%), in the anatomical plane between the Erector Spinae muscles and deeper surface of Rhomboid muscle. The space is identified under ecographic guidance, laterally to the spinous process of T5. The diffusion of the anesthetic solution along the space can be echographically appreciated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS approach. Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in diameter. Acceptance of awake VATS with written informed consent Exclusion Criteria: Age \< 18 years Patients who are pregnant or lactating Morbid obesity (BMI \> 35 ) Inability to understand and sign the Informed consent Proven allergy to local anesthetic drugs as required by this protocol Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection, redo surgery on the affected side)

Locations (1)

Sacro Cuore - Don Calabria Hospital

Negrar, Verona, Italy

Outcomes

Primary Outcomes

Dose Escalation of systemic anesthetics during the procedure

Percentage of patients who need sedation escalation

Time frame: 1 hour from the end of the procedure

Secondary Outcomes

Post operative pain perception

Peak pain perception in three time frames (eight hours each) starting from the end of the procedure and covering the first 24 hours after the procedure

Time frame: 8, 16, 24 hours from the end of procedure

Post operative pain management

Number of extra doses of rescue analgesia during the first 24 hours after the procedure.

Time frame: 8, 16, 24 hours from the end of procedure

Data from ClinicalTrials.gov

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