At a glance
ClinicalIndex Comparison Record- ✓Undergoing thoracotomy for oncologic thoracic surgery
- ✓Primary or secondary (metastatic) cancer
- ✓ASA class 1 or 2
- ✕Ropivacaine hypersensitivity or allergy
- ✕Psychiatric disorders
- ✕Unable to use visual analog scale for pain assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery
In Brief
A Phase 2 clinical trial evaluating Ropivacaine and Reference for Postoperative Pain and Cancer. Completed, enrolled 90 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.
8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.