ThoracotomyVAP BLOCKNCT04579276
Different Approaches to Thoracic Paravertebral Block
A study testing Thoracic paravertebral block and thoracic epidural analgesia in people with Thoracotomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracotomy
- What is being tested?
- Thoracic paravertebral block and thoracic epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2020to 8 Dec 2021
- 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
- Male or female ≥ 18 years of age.
- VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
- Signed consent.
- Scheduled surgeries.
Who cannot join
- Patient refusing to sign the consent form.
- Minors.
- Patients under any guardianship.
- All surgeries with pleura intervention: talc, pleurectomy, wall resection.
- Non trained anesthesiologist to ultrasound TPB.
- Presence of pain or daily use of painkillers prior to surgery.
- Medical history of homolateral thoracic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method
Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).
Read the detailed description
A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).
Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.
- Conditions
- Thoracotomy
- Being tested
- Thoracic paravertebral block, thoracic epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockProcedure or surgery
Intrathoracic method undergone through video assisted surgery (VATS
thoracic epidural analgesiaProcedure or surgery
locoregional analgesia under ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| "surgical" method | Experimental | Not described Receives: Procedure: Thoracic paravertebral block |
| "anesthetic" method | Active comparator | Not described Receives: Procedure: thoracic epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
Measured: 48 HOURS
Secondary outcomes (4)
Time occupancy of the operating room
Measured: 1 MONTH
visual analog scale of pain (VAS)
Measured: 12 HOURS
visual analog scale of pain (VAS)
Measured: 48HOURS
visual analog scale of pain (VAS)
Measured: 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start8 Sep 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThoracotomyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO- PRADALIE, Study director, Assistance Publique Hopitaux De MarseilleJOSEPHINE CHENESSEAU, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579276
- Sponsor's protocol ID
- 2020-11
- Other IDs
- 2020-A00483-36
- Acronym
- VAP BLOCK
- Status last verified
- Aug 2022
- First submitted
- 4 Sep 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chenesseau J, Fourdrain A, Pastene B, Charvet A, Rivory A, Baumstarck K, Bouabdallah I, Trousse D, Boulate D, Brioude G, Gust L, Vasse M, Braggio C, Mora P, Labarriere A, Zieleskiewicz L, Leone M, Thomas PA, D'Journo XB. Effectiveness of Surgeon-Performed Paravertebral Block Analgesia for Minimally Invasive Thoracic Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1255-1263. doi: 10.1001/jamasurg.2023.5228.
PubMed 37878299
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method
- ClinicalTrials.gov ID
- NCT04579276
- Acronym / sponsor ID
- VAP BLOCK / 2020-11
- Conditions
- Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 8 Oct 2020 (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.
Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).
Detailed description
A randomized prospective mono-centric non-inferiority controlled and simple blinded study comparing the "surgical" method (experimental group) to the "anesthetic" method (control group) for patients operated in thoracic minimally invasive surgery (VATS or RATS).
Recruitment: Patients undergoing therapeutic or diagnostic surgery in the thoracic ward of the university hospital of Marseille.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "surgical" method | Experimental | Procedure: Thoracic paravertebral block |
| "anesthetic" method | Active comparator | Procedure: thoracic epidural analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female ≥ 18 years of age.
- VATS or RATS with lung resection including wedges, segmentectomies or lobectomies.
- Signed consent.
- Scheduled surgeries.
Key exclusion criteria (7 listed)
- Patient refusing to sign the consent form.
- Minors.
- Patients under any guardianship.
- All surgeries with pleura intervention: talc, pleurectomy, wall resection.
- Non trained anesthesiologist to ultrasound TPB.
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 |
|---|---|---|
| Thoracic paravertebral blockIntrathoracic method undergone through video assisted surgery (VATS | Procedure or surgery | "surgical" method |
| thoracic epidural analgesialocoregional analgesia under ultrasound control | Procedure or surgery | "anesthetic" method |
Primary outcome
total morphine consumption
Time frame: 48 HOURS
4 secondary outcomes
Time occupancy of the operating room
Time frame: 1 MONTH
visual analog scale of pain (VAS)
Time frame: 12 HOURS
visual analog scale of pain (VAS)
Time frame: 48HOURS
visual analog scale of pain (VAS)
Time frame: 30 DAYS
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 8 May 2026.
- Results publication: PubMed 37878299Chenesseau J, Fourdrain A, Pastene B, Charvet A, Rivory A, Baumstarck K, Bouabdallah I, Trousse D, Boulate D, Brioude G, Gust L, Vasse M, Braggio C, Mora P, Labarriere A, Zieleskiewicz L, Leone M, Thomas PA, D'Journo XB. Effectiveness of Surgeon-Performed Paravertebral Block Analgesia for Minimally Invasive Thoracic Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Dec 1;158(12):1255-1263. doi: 10.1001/jamasurg.2023.5228.
Related trials for Thoracotomy
RecruitingPhase 2/3
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
Pain, Postoperative
Not yet recruitingObservational study
Preoperative Nutritional Status and Postoperative Outcomes in Geriatric Lung Resection
Thoracotomy, Toracosurgery
RecruitingObservational study
Continuous Erector Spinae Block Versus Thoracic Epidural Analgesia for the Prevention of Chronic Pain Following Thoracotomy: a Retrospective Study
Thoracic Surgery
Not yet recruiting
The Clinical Impact of Serratus Anterior VS. Erector Spinae Plane Block on Pain Management of Tube Thoracostomy in Emergency Department Patients.
Thoracostomy Pain Management, Pain Management
RecruitingPhase 2/3
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
Nerve Block/Methods
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.
Emilie GARRIDO- PRADALIE study director
Assistance Publique Hopitaux De Marseille
JOSEPHINE CHENESSEAU principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic paravertebral block and thoracic epidural analgesia in people with Thoracotomy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 7 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 8 May 2026. 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 France. 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. 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?
total morphine consumption (time frame: 48 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579276, which also lists 1 linked publication.
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 8 May 2026.