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Completed

NCT Number: NCT05798585

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ente Ospedaliero Cantonale, Bellinzona

Bellinzona, 6500, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block

Procedure

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

Primary outcomes

  1. cumulative dose of opioids at 24 and 48 h

    Time frame: 48 hours

    by using a PCA we will see how many times the patient asked for analgesia

Secondary outcomes

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

    Time frame: 48 hours

    we will test pain score in several moment by asking the NRS scale at rest and during cough

  2. Hypotension

    Time frame: 48 hours

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

  3. Cardio-pulmonary complications

    Time frame: 48 hours

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

  4. Procedure time and complications

    Time frame: 48 hours

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

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

    Time frame: 48 hours

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

  6. Episodes of vomiting

    Time frame: 48 hours

    We will observe if any episode of vomiting is present

  7. Episodes of urinary retention

    Time frame: 48 hours

    We will observe if any episode of urinary retention is present

  8. Length of hospital stay

    Time frame: 48 hours

    We will observe how long the hospital stay is

  9. Need for epidural catheter

    Time frame: 48 hours

    We will observe if the patient needs for an epidural catheter

Sponsors and collaborators

Lead sponsor

Andrea Saporito

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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