PainPhase 3PVBS-USguidedNCT02865226
Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)
A Phase 3 study testing paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) and paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual). in people with Pain, run by CHU de Reims at 1 site in France.
Trial summary
Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality. The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) and paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2016to 1 Sep 2021
- Phase
- Phase 3
- 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
- patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Who cannot join
- patient with neuropathy
- patient with body mass index superior to 35 kg/m2
- patient with contraindication for paravertebral block or local analgesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)
Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.
The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.
The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.
Read the detailed description
Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).
- Conditions
- Pain
- Being tested
- paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound), paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).
- Keywords
- thoracic surgery, thoracotomy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)Other
paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).Other
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) Receives: Other: paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) |
| control group | Active comparator | paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual) Receives: Other: paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual). |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Pain evaluated using a visual analog pain scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start16 Aug 2016
- Primary completion10 Oct 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865226
- Sponsor's protocol ID
- PA15082
- Acronym
- PVBS-USguided
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2016
- Last updated
- 18 Feb 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Efficacy of 2 Paravertebral Block Strategies in Thoracic Surgery by Thoracotomy: : by the Anesthetist (Paravertebral Block Guided by Ultrasound) and by the Thoracic Surgeon (Paravertebral Block Visual)
- ClinicalTrials.gov ID
- NCT02865226
- Acronym / sponsor ID
- PVBS-USguided / PA15082
- Conditions
- Pain
- Keywords
- thoracic surgery, thoracotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
Post-thoracotomy pain is one of the most severe. The local analgesia allows its effective control and a reduction of postoperative morbidity and mortality.
The gold standard for local analgesia is the thoracic epidural. However, this technique can be dangerous with severe complications.
The paravertebral block showed comparable efficacy to the thoracic epidural for local analgesia . In addition, it has a better safety profile. There are several installation techniques. The difference in efficiency of these laying techniques is unknown.
Detailed description
Compare the clinical effectiveness of two strategies of realization of paravertebral block: by the anesthetist before incision (paravertebral block guided by ultrasound) and by the thoracic surgeon at chest closure (paravertebral block visual).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) |
| control group | Active comparator | Other: paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient with thoracotomy indication for segmentectomy (s), lobectomy (s) lung or pulmonary wedge resection
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Key exclusion criteria (3 listed)
- patient with neuropathy
- patient with body mass index superior to 35 kg/m2
- patient with contraindication for paravertebral block or local analgesia
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 |
|---|---|---|
| paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) | Other | experimental group |
| paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual). | Other | control group |
Primary outcome
pain
Time frame: 24 hours
Pain evaluated using a visual analog pain scale
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 18 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound) and paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual). in people with Pain, run by CHU de Reims 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 3 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 18 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
pain (time frame: 24 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 18 Feb 2025.