Postoperative PainPhase 2ROPAL-1NCT00210132
Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
A Phase 2 study testing Ropivacaine and Reference in people with Postoperative Pain and Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain. There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Cancer
- What is being tested?
- Ropivacaine and Reference
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2003to 28 Feb 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Thoracotomy for oncology thoracic surgery
- Secondary or primary cancer
- American Society of Anesthesiology (ASA) class 1 or 2
Who cannot join
- Ropivacaine hypersensibility
- Psychiatric disorders
- Incapacity of using visual analog scale
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, 33076
About this study
Official title: Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain.
There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare but serious, and should be reserved for trained teams or patients with high morbidity.
Read more
Intrapleural analgesia is a simple method, performed by the surgeon intraoperatively.
Its effectiveness is controversial and the results remain inconsistent. Ropivacaine is a recently marketed local anesthetic with a modest vasoconstrictive effect. The variation in plasma levels of ropivacaine obtained by this technique has not yet been evaluated.
The purposes of this study are:
- To determine the efficacy of inter pleural analgesia
- To determine the plasmatic concentration of ropivacaine by inter pleural road
- Conditions
- Postoperative Pain, Cancer
- Being tested
- Ropivacaine, Reference
- Keywords
- Thoracic surgery, postoperative pain, ropivacaine, inter pleural analgesia
- Medical subject headings
- Pain, Postoperative, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours.
Treatment administration = every 6 hours for 48 hours.
ReferenceDrug
8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine Arm | Experimental | ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours.
Treatment administration = every 6 hours for 48 hours. Receives: Drug: Ropivacaine |
| Reference Arm | Sham comparator | 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Receives: Drug: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever).
A participant is considered to have major pain if VAS score is >= 70.
Measured: Between surgery and up to 48 hours
Secondary outcomes (1)
Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy
Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg).
Measured: between surgery and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study start1 Oct 2003
- Primary completion30 Jun 2006
- Study completion28 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre GEKIERE, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210132
- Sponsor's protocol ID
- IB2003-23
- Acronym
- ROPAL-1
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2005
- Last updated
- 8 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
- ClinicalTrials.gov ID
- NCT00210132
- Acronym / sponsor ID
- ROPAL-1 / IB2003-23
- Conditions
- Postoperative Pain, Cancer
- Keywords
- Thoracic surgery, postoperative pain, ropivacaine, inter pleural analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 30 Jun 2006 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 8 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracic surgery via posterolateral thoracotomy causes significant postoperative pain.
There are several methods of postoperative pain relief, including intravenous analgesics and local-regional analgesia techniques. Although thoracic epidural remains the gold standard, it is not without complications, which are rare but serious, and should be reserved for trained teams or patients with high morbidity.
Intrapleural analgesia is a simple method, performed by the surgeon intraoperatively.
Its effectiveness is controversial and the results remain inconsistent. Ropivacaine is a recently marketed local anesthetic with a modest vasoconstrictive effect. The variation in plasma levels of ropivacaine obtained by this technique has not yet been evaluated.
The purposes of this study are:
- To determine the efficacy of inter pleural analgesia
- To determine the plasmatic concentration of ropivacaine by inter pleural road
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine Arm | Experimental | Drug: Ropivacaineropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. |
| Reference Arm | Sham comparator | Drug: Reference8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Thoracotomy for oncology thoracic surgery
- Secondary or primary cancer
- American Society of Anesthesiology (ASA) class 1 or 2
Key exclusion criteria (3 listed)
- Ropivacaine hypersensibility
- Psychiatric disorders
- Incapacity of using visual analog scale
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 |
|---|---|---|
| Ropivacaineropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. | Drug | Ropivacaine Arm |
| Reference8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. | Drug | Reference Arm |
Primary outcome
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy
Time frame: Between surgery and up to 48 hours
Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have major pain if VAS score is >= 70.
1 secondary outcome
Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy
Time frame: between surgery and 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jean-Pierre GEKIERE, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine and Reference in people with Postoperative Pain and Cancer, run by Institut Bergonié 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 3 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 8 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy (time frame: Between surgery and up to 48 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 8 Sep 2025.