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

Sponsor

Andrea Saporito (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05798585

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgery Thoracic	Procedure: ESP block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

cumulative dose of opioids at 24 and 48 h [48 hours]
by using a PCA we will see how many times the patient asked for analgesia

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ente Ospedaliero Cantonale, Bellinzona	Bellinzona		Switzerland	6500

Sponsors and Collaborators

Andrea Saporito

Investigators

Study Chair: Andrea Saporito, Anesth, Ente Ospedaliero Cantonale, Bellinzona

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrea Saporito, Head of Anesthesiology, PD DR MED, Ente Ospedaliero Cantonale, Bellinzona

ClinicalTrials.gov Identifier:

NCT05798585

Other Study ID Numbers:

TVPESP trial

First Posted:

Apr 4, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm, Dissecting

Study Results

No Results Posted as of Apr 4, 2023