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
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