SurgeryNCT05798585
Comparing Erector Spinae Plane (ESP) and Thoracic Paravertebral (TPV) Block Analgesic Effect After Elective VATS
A study testing ESP block in people with Surgery and Thoracic, run by Andrea Saporito at 1 site in Switzerland.
Trial summary
The aim of the study is to compare two different locoregional techniques in VATS. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ESP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 year of age undergoing elective VATS lung resection at ORBV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ente Ospedaliero Cantonale, Bellinzona
Bellinzona, Bellinzona, 6500
About this study
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
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
- Being tested
- ESP block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative dose of opioids at 24 and 48 h
by using a PCA we will see how many times the patient asked for analgesia
Measured: 48 hours
Secondary outcomes (9)
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
Measured: 48 hours
Hypotension
we will compare the systolic pressure before anesthesia and after the block have been performed
Measured: 48 hours
Cardio-pulmonary complications
we will check if any cardio-pulmonary complication is present after surgery during the hospital stay
Measured: 48 hours
Procedure time and complications
we will observe the time necessary to perform the block and the complications after it
Measured: 48 hours
Need for anti-nausea medication (dosage, doses and time points)
We will observe if the patient need any type of anti-nausea medication
Measured: 48 hours
Episodes of vomiting
We will observe if any episode of vomiting is present
Measured: 48 hours
Episodes of urinary retention
We will observe if any episode of urinary retention is present
Measured: 48 hours
Length of hospital stay
We will observe how long the hospital stay is
Measured: 48 hours
Need for epidural catheter
We will observe if the patient needs for an epidural catheter
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start31 Mar 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Saporito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Saporito, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Andrea Saporito, Anesth, Study chair, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798585
- Sponsor's protocol ID
- TVPESP trial
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05798585
- Acronym / sponsor ID
- TVPESP trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Andrea SaporitoUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare two different locoregional techniques in VATS.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided ESP block + sham US-guided TPV block | Experimental | Procedure: ESP blockESP block will be performed with local anesthetic under US guide; instead TPV block with physiological solution |
| sham US-guided ESP block + US-guided TPV block | Sham comparator | Procedure: ESP blockESP block will be performed with physiological solution under US guide; instead TPV block with local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over 18 year of age undergoing elective VATS lung resection at ORBV
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESP blockUS 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 | Procedure or surgery | US-guided ESP block + sham US-guided TPV block, sham US-guided ESP block + US-guided TPV block |
Primary outcome
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
9 secondary outcomes
Pain scores at 4h, 8h, 24h, 48h via numeric rating scale (NRS) at rest and during cough
Time frame: 48 hours
Hypotension
Time frame: 48 hours
Cardio-pulmonary complications
Time frame: 48 hours
Procedure time and complications
Time frame: 48 hours
Need for anti-nausea medication (dosage, doses and time points)
Time frame: 48 hours
Episodes of vomiting
Time frame: 48 hours
Episodes of urinary retention
Time frame: 48 hours
Length of hospital stay
Time frame: 48 hours
Need for epidural catheter
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Saporito, Anesth study chair
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP block in people with Surgery and Thoracic, run by Andrea Saporito at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative dose of opioids at 24 and 48 h (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.