Pain, PostoperativePhase 3PARAVINCT01082744
Thoracic Paravertebral Block for Postoperative Analgesia After Video-assisted Thoracic Surgery.
A Phase 3 study testing Ropivacaine + Sufentanil and Ropivacaine in people with Pain, Postoperative, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine + Sufentanil and Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2014
- 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 scheduled for planned video-assisted thoracic surgery
- Patient that consent to participate
- Planned placement of paravertebral catheter
- Patient having a medical insurance
Who cannot join
- Patient less than 18 years
- Refusal to participate
- Known pregnancy
- Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material
- Intolerance to sufentanil and/or morphine
- Chronic consumption of opiates
- Preoperative chronic pain syndrome
- Patient having a contraindication to placement of paravertebrtal catheter
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon, Hopital Louis Pradel, Department of Anesthesiology
Bron, 69500
About this study
Official title: Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.
The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine + Sufentanil, Ropivacaine
- Keywords
- Paravertebral Block, Regional Anesthesia, Anesthetics Local, Ropivacaine, Sufentanil, Pain Postoperative, Chronic Pain, Thoracic Surgery Video-Assisted.
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + SufentanilDrug
Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
RopivacaineDrug
Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Continuous paravertebral block with ropivacaine | Active comparator | Not described Receives: Drug: Ropivacaine |
| Continuous paravertebral block with ropivacaine and sufentanil | Experimental | Not described Receives: Drug: Ropivacaine + Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption during the first 48 hours
Measured: 48 hours
Secondary outcomes (4)
Acute pain
using the Visual Analogue Scale (VAS) score
Measured: 48 hours
Biological measurements
Oxygen saturation, level of sedation, respiratory rate, nausea, vomiting, itching, urine retention, blood pressure, heart rate
Measured: 48 hours
Patient satisfaction
Measured: 48 hours
Chronic pain
assessed with the Saint-Antoine Pain Questionnaire (French version of the Mac Gill Pain Questionnaire) and the DN4 questionnaire.
Measured: 3 and 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2014
- Study completionDec 2014
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 Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian BAUER, MD, Principal investigator, Hospices Civils de Lyon, Hopital Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082744
- Sponsor's protocol ID
- 2009.558
- Other IDs
- 2009-014832-38, 2009
- Acronym
- PARAVI
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2010
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauer C, Pavlakovic I, Mercier C, Maury JM, Koffel C, Roy P, Fellahi JL. Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.
PubMed 29373333
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block: a Comparative Study of Ropivacaine With Ropivacaine and Sufentanil for Treating Pain After Video-assisted Thoracic Surgery.
- ClinicalTrials.gov ID
- NCT01082744
- Acronym / sponsor ID
- PARAVI / 2009.558
- Conditions
- Pain, Postoperative
- Keywords
- Paravertebral Block, Regional Anesthesia, Anesthetics Local, Ropivacaine, Sufentanil, Pain Postoperative, Chronic Pain, Thoracic Surgery Video-Assisted.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Mar 2010 (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.
The use of paravertebral catheters is a recommended technique to achieve postoperative analgesia after thoracic surgery. To date there is no consensus on which drug regime (local anesthetics with or without opioid) is best. The aim of this prospective clinical trial is to determine wether the use of ropivacaine and sufentanil injected through a thoracic paravertebral catheter results in decreased acute postoperative pain compared with plain ropivacaine in patients after thoracoscopic lung surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous paravertebral block with ropivacaine | Active comparator | Drug: Ropivacaine |
| Continuous paravertebral block with ropivacaine and sufentanil | Experimental | Drug: Ropivacaine + Sufentanil |
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 scheduled for planned video-assisted thoracic surgery
- Patient that consent to participate
- Planned placement of paravertebral catheter
- Patient having a medical insurance
Key exclusion criteria (8 listed)
- Patient less than 18 years
- Refusal to participate
- Known pregnancy
- Known allergies to local anesthetics, sufentanil and /or to iodinated contrast material
- Intolerance to sufentanil and/or morphine
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 |
|---|---|---|
| Ropivacaine + SufentanilSufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours | Drug | Continuous paravertebral block with ropivacaine and sufentanil |
| RopivacaineRopivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours | Drug | Continuous paravertebral block with ropivacaine |
Primary outcome
morphine consumption during the first 48 hours
Time frame: 48 hours
4 secondary outcomes
Acute pain
Time frame: 48 hours
Biological measurements
Time frame: 48 hours
Patient satisfaction
Time frame: 48 hours
Chronic pain
Time frame: 3 and 6 monthes
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 19 Dec 2025.
- Results publication: PubMed 29373333Bauer C, Pavlakovic I, Mercier C, Maury JM, Koffel C, Roy P, Fellahi JL. Adding sufentanil to ropivacaine in continuous thoracic paravertebral block fails to improve analgesia after video-assisted thoracic surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):766-773. doi: 10.1097/EJA.0000000000000777.
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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.
Christian BAUER, MD principal investigator
Hospices Civils de Lyon, Hopital Louis Pradel
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 Ropivacaine + Sufentanil and Ropivacaine in people with Pain, Postoperative, run by Hospices Civils de Lyon 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 19 Dec 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?
morphine consumption during the first 48 hours (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 NCT01082744, 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 19 Dec 2025.