NCT00210132: ROPAL-1

Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

Completed Phase 2 Results posted Last updated 8 September 2025

What this trial tests

Phase 2 trial testing Ropivacaine in Postoperative Pain in 90 participants. Completed in 28 February 2008.

Timeline

1 October 2003

Primary endpoint
30 June 2006

28 February 2008

Quick facts

Lead sponsor	Institut Bergonié
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	90
Start date	1 October 2003
Primary completion	30 June 2006
Estimated completion	28 February 2008
Sites	1 location across France

Drugs / interventions tested

• Ropivacaine (ROPIVACAINE) — full drug profile →
• Reference

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Cancer — all drugs for Cancer →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Postoperative Pain or Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy Primary · 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.

Group	Value	95% CI
Ropivacaine Arm	4
Reference Arm	3

Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy Secondary · between surgery and 48 hours

Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg).

Group	Value	95% CI
Ropivacaine Arm	29.9	± 23.5
Reference Arm	15.6	± 17.4

Sponsor's own description

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:

1. To determine the efficacy of inter pleural analgesia
2. To determine the plasmatic concentration of ropivacaine by inter pleural road

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.