Saint Die Des Vosges

Researchers are evaluating the long-term safety and effectiveness of DISCOGEL4, a gelified ethanol device, compared with intradiscal steroid infiltration for treating refractory lumbar discogenic pain. This study is designed as a randomized, prospective, single-blind clinical trial involving patients who have chronic discogenic pain not responding to conservative treatments. The trial aims to confirm previous clinical data from over 600 patients by monitoring a larger group over two years. Participants will be randomly assigned to receive either a single intradiscal injection of DISCOGEL4 0.6 to 2.2 ml or a single injection of the authorized steroid drug Hydrocortancyl 2.5% 0.2 to 2.0 ml. Both treatments are used according to their approved instructions. The study includes a comparison of short-term efficacy at 3 months and long-term efficacy and safety up to 24 months. Economic data and procedure durations will also be collected. During the study, participants will undergo various assessments including questionnaires Oswestry and MacNab, radiography, and magnetic resonance imaging at multiple time points 3, 12, and 24 months. Researchers will monitor both short-term and long-term safety and efficacy, as well as procedure-related factors. The total follow-up period extends to two years, ensuring comprehensive evaluation of treatment effects and participant well-being throughout the study.

Intraoperative hypotension, a common issue during surgery, increases the risk of complications and death after surgery, especially in patients who are older and at high postoperative risk. This trial evaluates whether carefully monitoring and optimizing both sedation and pain relief during surgery can reduce organ dysfunction and mortality in these high-risk patients. The study specifically focuses on patients aged 75 and older undergoing high-risk surgery under general anesthesia involving hypnotics and opioids. Participants will be randomly assigned to one of two groups. One group will receive anesthesia guided by advanced monitoring systems that track sedation levels and pain responses using devices like BIS17, SedLine4, Entropy Sensor17, and PMD-2004. The other group will receive standard anesthesia based on the anesthetists clinical judgment without these monitoring tools. The study aims to compare the impact of these approaches on intraoperative hypotension and postoperative outcomes. During the study, researchers will monitor doses of hypnotics and opioids used, the number and duration of hypotensive episodes, and the time spent within target sedation and analgesia ranges. They will also assess postoperative complications such as acute kidney injury, cardiovascular and neurological problems, delirium, respiratory failure, length of intensive care and hospital stays, and mortality within 30 days after surgery. Pain levels and opioid use will be evaluated 48 hours after surgery. The total study duration extends through the postoperative period up to 30 days.