NCT00210132

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

Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Postoperative Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Ropivacaine	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.
DRUG	Reference	8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.

Timeline

• Start date: 2003-10-01
• Primary completion: 2006-06-30
• Completion: 2008-02-28
• First posted: 2005-09-21
• Last updated: 2025-09-08
• Results posted: 2025-09-08

Locations

1 site across 1 country: France