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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Pain Blocks in Awake Thoracic Surgery: A Randomized Prospective Trial to Test the Non-inferiority of Erector Spinae Plane Block (ESPB) in Comparison With Paravertebral Block During Non-intubate, Thoracoscopic Lung Resection.

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Procedure: Paravertebral Block (PVB)
* Procedure: Erector Spinae Plane Block (ESPB)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients will be randomized between two groups according to loco regional pain management: Paravertebral block Erector Spinae Plane Block Allocation to one treatment group or another will be randomized with the aim of create two unbiased groups formed out of the same group of patients. Randomization will be provided by a software.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paravertebral block (PVB)<br>Intraoperative pain management Sedation Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml). Paravertebral Block Post operative pain management Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours | Procedure: Paravertebral Block (PVB)<br>* 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.<br>|
| Experimental: Erector Spinae Plane Block (ESPB)<br>Intraoperative pain management Sedation Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml). Erector Spinae Plane Block Post operative pain management Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours | Procedure: Erector Spinae Plane Block (ESPB)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Escalation of systemic anesthetics during the procedure | Percentage of patients who need sedation escalation | 1 hour from the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 8, 16, 24 hours from the end of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Awake Thoracic Surgery, Erector Spinae Plane Block