Video Assisted ThoracoscopyPhase 4DRAVATSNCT03852862
Double Regional Anesthesia in Video Assisted Thoracoscopy
A Phase 4 study testing Serratus plane block and paravertebral block and paravertebral block in people with Video Assisted Thoracoscopy and Anesthesia, run by University Hospital, Rouen at 1 site in France.
Trial summary
Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Video Assisted Thoracoscopy, Anesthesia
- What is being tested?
- Serratus plane block and paravertebral block and paravertebral block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 8 May 2019to 10 Nov 2020
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 75 years;
- Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy);
- Subject affiliated to a social security scheme;
- Subject having signed an informed consent
Who cannot join
- Chronic treatment with opiates;
- Contraindication to administration of morphine;
- Allergy to local anesthetics or contraindications to the use of ropivacaine;
- Contraindication to the realization of paravertebral blocks and serratus;
- Pregnancy, breastfeeding;
- Severe obesity (BMI > 40 kg/m²);
- Renal impairment (GFR < 30 mL/min) or known severe hepatic impairment;
- Difficulties of comprehension preventing the collection of consent and the realization of the study;
Trial locations and contacts
1 site in 1 country.
About this study
Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone
- Conditions
- Video Assisted Thoracoscopy, Anesthesia
- Being tested
- Serratus plane block and paravertebral block, paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus plane block and paravertebral blockDrug
Single Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection)
paravertebral blockDrug
Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)
| Study group | Role | What they receive |
|---|---|---|
| Serratus plane block with paravertebral block | Experimental | Association of Serratus plane block and paravertebral block for anesthesia Receives: Drug: Serratus plane block and paravertebral block |
| paravertebral block alone | Active comparator | Paravertebral block for anesthesia Receives: Drug: paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of opioids drug administrated
Measured: 24 hours postoperatively
Secondary outcomes (2)
Length of stay in recovery room
Measured: 24 hours postoperatively
Total duration of hospitalization
Measured: during the 28 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start8 May 2019
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
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 Video Assisted ThoracoscopyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Melody DUSSEAUX, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852862
- Sponsor's protocol ID
- 2017/182/HP
- Acronym
- DRAVATS
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2019
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dusseaux MM, Grego V, Baste JM, Besnier E, Boujibar F, Koscianski G, Ben Yahia MM, Compere V, Clavier T, Vannier M, Selim J. Paravertebral block combined with serratus anterior plane block after video-assisted thoracic surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2023 Jul 3;64(1):ezad170. doi: 10.1093/ejcts/ezad170.
PubMed 37094177
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Regional Anesthesia in Video Assisted Thoracoscopy
- ClinicalTrials.gov ID
- NCT03852862
- Acronym / sponsor ID
- DRAVATS / 2017/182/HP
- Conditions
- Video Assisted Thoracoscopy, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 25 Feb 2019 (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.
Monocentric, randomized, controlled, single-blind study who's aim is to demonstrate the efficacy of the association of paravertebral block and serratus plane block with paravertebral block alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus plane block with paravertebral block | Experimental | Drug: Serratus plane block and paravertebral blockAssociation of Serratus plane block and paravertebral block for anesthesia |
| paravertebral block alone | Active comparator | Drug: paravertebral blockParavertebral block for anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 to 75 years;
- Programmed for unilateral videothoracoscopy for anatomical resection (segmentectomy, lobectomy);
- Subject affiliated to a social security scheme;
- Subject having signed an informed consent
Key exclusion criteria (8 listed)
- Chronic treatment with opiates;
- Contraindication to administration of morphine;
- Allergy to local anesthetics or contraindications to the use of ropivacaine;
- Contraindication to the realization of paravertebral blocks and serratus;
- Pregnancy, breastfeeding;
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 |
|---|---|---|
| Serratus plane block and paravertebral blockSingle Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection) | Drug | Serratus plane block with paravertebral block |
| paravertebral blockSingle Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection) | Drug | paravertebral block alone |
Primary outcome
Number of opioids drug administrated
Time frame: 24 hours postoperatively
2 secondary outcomes
Length of stay in recovery room
Time frame: 24 hours postoperatively
Total duration of hospitalization
Time frame: during the 28 days postoperatively
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 17 Apr 2026.
- Results publication: PubMed 37094177Dusseaux MM, Grego V, Baste JM, Besnier E, Boujibar F, Koscianski G, Ben Yahia MM, Compere V, Clavier T, Vannier M, Selim J. Paravertebral block combined with serratus anterior plane block after video-assisted thoracic surgery: a prospective randomized controlled trial. Eur J Cardiothorac Surg. 2023 Jul 3;64(1):ezad170. doi: 10.1093/ejcts/ezad170.
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.
Marie-Melody DUSSEAUX, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serratus plane block and paravertebral block and paravertebral block in people with Video Assisted Thoracoscopy and Anesthesia, run by University Hospital, Rouen 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 8 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 17 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of opioids drug administrated (time frame: 24 hours postoperatively). 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 NCT03852862, 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 17 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.