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

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

The aim of the study is to compare two different locoregional techniques in VATS.

Study Overview

• Status: Completed
• Conditions: Surgery; Thoracic
• Intervention / Treatment: Procedure: ESP block

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bellinzona, Switzerland, 6500
    • Ente Ospedaliero Cantonale, Bellinzona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: US-guided ESP block + sham US-guided TPV block; ESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution	Procedure: ESP block; 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
Sham Comparator: sham US-guided ESP block + US-guided TPV block; ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic	Procedure: ESP block; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Andrea Saporito
• Investigators: Study Chair: Andrea Saporito, Anesth, Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: TVPESP trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No