PainPhase 4NCT01698203
Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy
A Phase 4 study testing ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) and ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) in people with Pain and Thoracotomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Thoracotomy
- What is being tested?
- ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) and ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2012to 11 Oct 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for thoracotomy who presented with contraindications to TEA.
- Contraindications to TEA are :
- Patient's refusal after informations about advantages and risks of the technique
- Anti platelets treatment that can't be discontinued
- Anticoagulants at a curative dosage
- haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75%
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- Systemic or local infection of the puncture point
- 2 and 3 grade atrio-ventricular heart block without pacing
- Severe aortic valve stenosis
- Kyphoscoliosis
- certain neurological disorders
Who cannot join
- Patient's refusal to participate in the study
- Psychiatric disorder (impossibility to collect the informed consent)
- Patient under juridical protection
- On going an other study
- Pregnancy, breastfeeding
- Non balanced epilepsy
Show all 12Show fewer
- 3 grade auriculo-ventricular heart block without pacing
- Severe hepatocellular insufficiency
- Anti arrhythmic treatment : class III of the Vaughan William's classification
- Skin infection of the puncture point
- Allergy to aminoamides local anaesthetic
- Surgical difficulties to insert paravertebral catheter
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Civil - NHC Département d'Anesthésiologie
Strasbourg, Alsace, 67091
About this study
Official title: Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)
Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.
- Conditions
- Pain, Thoracotomy
- Being tested
- ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun), Placebo, ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)Drug
The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.
PlaceboDrug
In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.
ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)Drug
The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | Not described Receives: Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun); Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intravenous morphine consumption (mg)
Measured: the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study start14 Oct 2012
- Primary completion14 Oct 2012
- Study completion11 Oct 2018
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 PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Helms, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698203
- Sponsor's protocol ID
- 5277
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2012
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.
PubMed 21377888
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
- Postoperative Analgesia After Thoracotomy Without Thoracic Epidural Analgesia: Continuous Wound Catheter Analgesia Associated With Intravenous Morphine Patient-Controlled-Analgesia (PCA)
- ClinicalTrials.gov ID
- NCT01698203
- Acronym / sponsor ID
- 5277
- Conditions
- Pain, Thoracotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Oct 2012 (actual)
- Primary completion
- 14 Oct 2012 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 2 Oct 2012 (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.
Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Drug: ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun), Drug: ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients scheduled for thoracotomy who presented with contraindications to TEA.
- Patient's refusal after informations about advantages and risks of the technique
- Anti platelets treatment that can't be discontinued
- Anticoagulants at a curative dosage
- haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75%
Key exclusion criteria (12 listed)
- Patient's refusal to participate in the study
- Psychiatric disorder (impossibility to collect the informed consent)
- Patient under juridical protection
- On going an other study
- 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 |
|---|---|---|
| ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter. | Drug | ropivacaine |
| PlaceboIn the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour. | Drug | placebo |
| ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour | Drug | ropivacaine |
Primary outcome
Total intravenous morphine consumption (mg)
Time frame: the first 48 hours after surgery
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 21377888Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.
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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.
Olivier Helms, MD principal investigator
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 ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) and ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun) in people with Pain and Thoracotomy, run by University Hospital, Strasbourg, France 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 11 inclusion and 12 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. 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.
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?
Total intravenous morphine consumption (mg) (time frame: the first 48 hours after surgery). 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 NCT01698203, 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; AzTrials last refreshed its copy on 7 Nov 2026.