Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS

Study Overview
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Brief Summary
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The aim of the study is to compare two different locoregional techniques in VATS.

Detailed Description
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There are clear clinical and logistic reasons for pursuing the best possible post-operative pain management avoiding the negative side effects of opioid treatment; in order to garantee an enhanced recovery after surgery. A short hospital stay is fundamental to reduce patient morbidity and costs. Regional anesthetic nerve blocks are an ideal option to achieve this goal. Paravertebral block serves as an ideal approach for thoracic and abdominal surgery through delivering segmental anesthesia of operative sites. Thoracic paravertebral block has superior analgesia as well as fewer complications than systemic opioids. It has been successfully applied in sternotomy, breast surgery, abdominoplasty, and laparoscopic cholecystectomy. ESP block is a recently described technique, with promising results in different scenarios. It probabily has a better risk profile than PVB, for its lower possibility of accidental pleural puncture and reabsorption of local anesthtetic than PVB one

Official Title
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Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective Video Assisted Thoracic Surgery (VATS): a Single Center, Randomized, Multiple-blinded, Controlled, Non Inferiority Trial

Conditions
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Surgery, Thoracic

Intervention / Treatment
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* Procedure: ESP block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 18 year of age undergoing elective VATS lung resection at ORBV Exclusion Criteria: patients with inability to consent, contraindications to standard care, or factors that can cause bias in interpretation, absolute contraindications to the regional anesthesia techniques studied (patient's refusal, allergy to local anesthetics, infections in the site of injection). Pregnant women are not a target study-group so they are excluded for design simplification. Conversion to the open technique will be a post-randomization exclusion factor concerning the main outcomes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US-guided ESP block + sham US-guided TPV block<br>ESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution | Procedure: ESP block<br>* US guided ESP infiltration (saline solution vs Ropivacaine 0.375% according to randomization): unilateral injection of 0,4 ml kg -1 (ideal weight)2 under US guidance between the deep fascia of erector spinae muscle and the two transverse processes at the level of the 5th thoracic vertebrae. Duration approximately 10-15 minutes<br>|
| Sham Comparator: sham US-guided ESP block + US-guided TPV block<br>ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic | Procedure: ESP block<br>* US guided ESP infiltration (saline solution vs Ropivacaine 0.375% according to randomization): unilateral injection of 0,4 ml kg -1 (ideal weight)2 under US guidance between the deep fascia of erector spinae muscle and the two transverse processes at the level of the 5th thoracic vertebrae. Duration approximately 10-15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative dose of opioids at 24 and 48 h | by using a PCA we will see how many times the patient asked for analgesia | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough | we will test pain score in several moment by asking the NRS scale at rest and during cough | 48 hours | 
| Hypotension | we will compare the systolic pressure before anesthesia and after the block have been performed | 48 hours | 
| Cardio-pulmonary complications | we will check if any cardio-pulmonary complication is present after surgery during the hospital stay | 48 hours | 
| Procedure time and complications | we will observe the time necessary to perform the block and the complications after it | 48 hours | 
| Need for anti-nausea medication (dosage, doses and time points) | We will observe if the patient need any type of anti-nausea medication | 48 hours | 
| Episodes of vomiting | We will observe if any episode of vomiting is present | 48 hours | 
| Episodes of urinary retention | We will observe if any episode of urinary retention is present | 48 hours | 
| Length of hospital stay | We will observe how long the hospital stay is | 48 hours | 
| Need for epidural catheter | We will observe if the patient needs for an epidural catheter | 48 hours |