ClinicalTrials.gg
CompletedNCT05798585Updated Feb 28, 2025

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

An interventional study of ESP block in Surgery and Thoracic, sponsored by Andrea Saporito. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Andrea Saporito · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Surgery
  • Thoracic
03

In context

Lead sponsor

Andrea Saporito is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with inability to consent, 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureESP 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

06

What researchers measure

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

    Time frame: 48 hours

Secondary outcomes

  1. 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

    Time frame: 48 hours

  2. Hypotension

    we will compare the systolic pressure before anesthesia and after the block have been performed

    Time frame: 48 hours

  3. Cardio-pulmonary complications

    we will check if any cardio-pulmonary complication is present after surgery during the hospital stay

    Time frame: 48 hours

  4. Procedure time and complications

    we will observe the time necessary to perform the block and the complications after it

    Time frame: 48 hours

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

    We will observe if the patient need any type of anti-nausea medication

    Time frame: 48 hours

  6. Episodes of vomiting

    We will observe if any episode of vomiting is present

    Time frame: 48 hours

  7. Episodes of urinary retention

    We will observe if any episode of urinary retention is present

    Time frame: 48 hours

  8. Length of hospital stay

    We will observe how long the hospital stay is

    Time frame: 48 hours

  9. Need for epidural catheter

    We will observe if the patient needs for an epidural catheter

    Time frame: 48 hours

07

Study locations

1 site
  • Ente Ospedaliero Cantonale, Bellinzona
    Bellinzona, Bellinzona 6500, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05798585
Lead sponsor
Andrea Saporito
Responsible party
Andrea Saporito (Head of Anesthesiology, PD DR MED, Ente Ospedaliero Cantonale, Bellinzona) — Sponsor-investigator
First posted
Apr 4, 2023
Start date
Mar 31, 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 28, 2025

Study contacts

Andrea Saporito, Anesth
study chair · Ente Ospedaliero Cantonale, Bellinzona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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