Saint Die Des Vosges

This research aims to compare the effectiveness and safety of two treatments for lumbar discogenic pain that does not respond to conservative care. The study evaluates a gelified ethanol device called DISCOGEL4, which has been used since 2007 and recently regained its CE mark. Researchers will compare DISCOGEL4 with an intradiscal steroid called Prednisolone acetate in a randomized, single-blind trial involving patients with chronic lumbar disc pain confirmed by MRI. Participants will be randomly assigned to receive either an intradiscal injection of ethanol gel (DISCOGEL4) or an intradiscal steroid injection (Prednisolone acetate). Both treatments are authorized and used according to their intended purposes. The study is conducted across multiple centers in a national setting, with patients and evaluators blinded to the treatment assignment. The primary focus is on short-term effectiveness measured at three months, with economic data also collected. During the study, patients will be monitored for treatment effectiveness and safety over a two-year follow-up. Evaluations include clinical assessments and patient-reported outcomes. The study monitors adherence and records any adverse events. The goal is to provide real-life data on the performance and safety of DISCOGEL4 compared to steroids, helping to inform treatment decisions for patients with refractory lumbar discogenic pain.

Researchers are investigating the effects of monitoring both sedation and pain control medications during surgery on reducing postoperative organ dysfunction and mortality in patients at high risk after surgery. This study focuses on elderly patients aged 75 and older who have additional risk factors and undergo high-risk surgery under general anesthesia, as intraoperative low blood pressure is common and linked to worse outcomes. The goal is to evaluate if carefully adjusting anesthetic medications using specialized monitoring can improve patient safety and recovery. Participants will be divided into two groups: one group will have anesthesia managed with the help of sedation and analgesia monitors that track brain activity and pain levels to guide medication dosing. The other group will receive anesthesia based on the anesthetist's usual clinical judgment without these monitors. The monitored group will have specific targets for sedation and pain scores using devices like BIS™, SedLine®, Entropy Sensor™, and PMD-200® nociception monitor. Both groups will receive hypnotic and opioid drugs as part of their anesthesia during surgery. During the study, patients will be observed for 30 days after surgery for outcomes including death, kidney injury, cardiovascular and neurological complications, and delirium. Researchers will collect and analyze data on these events to assess the impact of monitoring. Participants must have planned hospital stays longer than 48 hours and will be followed through their postoperative period. This multi-center randomized study aims to determine whether combined sedation and analgesia monitoring can reduce complications related to anesthesia in high-risk surgical patients.