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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05798585
• Other study ID #: TVPESP trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Surgery
• Thoracic

Intervention

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

Locations

Country	Name	City	State
Switzerland	Ente Ospedaliero Cantonale, Bellinzona	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
Andrea Saporito

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Hypotension	we will compare the systolic pressure before anesthesia and after the block have been performed	48 hours
Secondary	Cardio-pulmonary complications	we will check if any cardio-pulmonary complication is present after surgery during the hospital stay	48 hours
Secondary	Procedure time and complications	we will observe the time necessary to perform the block and the complications after it	48 hours
Secondary	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
Secondary	Episodes of vomiting	We will observe if any episode of vomiting is present	48 hours
Secondary	Episodes of urinary retention	We will observe if any episode of urinary retention is present	48 hours
Secondary	Length of hospital stay	We will observe how long the hospital stay is	48 hours
Secondary	Need for epidural catheter	We will observe if the patient needs for an epidural catheter	48 hours