NCT05798585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.8 years

First QC Date

January 13, 2023

Last Update Submit

February 26, 2025

Conditions

SurgeryThoracic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough

    48 hours

  • Hypotension

    48 hours

  • Cardio-pulmonary complications

    48 hours

  • Procedure time and complications

    48 hours

  • Need for anti-nausea medication (dosage, doses and time points)

    48 hours

  • +4 more secondary outcomes

Study Arms (2)

US-guided ESP block + sham US-guided TPV block

EXPERIMENTAL

ESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution

Procedure: ESP block

sham US-guided ESP block + US-guided TPV block

SHAM COMPARATOR

ESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic

Procedure: ESP block

Interventions

ESP blockPROCEDURE

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

US-guided ESP block + sham US-guided TPV blocksham US-guided ESP block + US-guided TPV block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 year of age undergoing elective VATS lung resection at ORBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ente Ospedaliero Cantonale, Bellinzona

Bellinzona, Bellinzona, 6500, Switzerland

Location

Study Officials

  • Andrea Saporito, Anesth

    Ente Ospedaliero Cantonale, Bellinzona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Anesthesiology, PD DR MED

Study Record Dates

First Submitted

January 13, 2023

First Posted

April 4, 2023

Study Start

March 31, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)