Chest Tube with Sustained Release of Local Anesthetic Agents for Pain Reduction in Cardiothoracic Surgeries

Project Summary: Chest tubes are commonly implanted between the ribs and into the pleural space after cardiac surgery and during management of thoracic injury. While these devices are essential for providing drainage of air and fluid from this space, they are exquisitely painful because they mechanically irritate sensitive pleural membranes and intercostal space with normal breathing and upper body movements. In fact, the indwelling chest tube is often listed by patients as one of the most painful and dissatisfying aspects of their post-surgical care. The severity of the pain necessitates serial, systemic administration of opiate medications in approximately 80% of patients with a chest tube. This opioid use produces many deleterious side effects including respiratory depression, sedation, hypotension, urinary retention, and nausea/vomiting that slow patient recovery. In addition, opioid use comes with a risk of dependence, potentially leading to life altering addiction issues for some patients. The overall goal of this proposal is to create and test a drug eluting chest tube to locally manage the pain of the device using a non-narcotic anesthetic agent. Local treatment of the pain of a chest tube would be highly advantageous in reducing or eliminating the need for systemic opioids for controlling pain from the implanted chest tube. This would provide a significant benefit to patients in reducing pain, speeding recovery, and lowering the risk of side effects and addiction.Using a novel, patent pending technique, our preliminary studies have demonstrated that we are able deliver high levels of anesthetic agents locally from a chest tube for several weeks. The overall goal of this proposal is to develop this technology into a clinical device that can be tested in human studies. We propose the following specific aims: Aim 1. Complete GMP/GLP studies of drug release kinetics, drug stability and manufacturing repeatability for the drug releasing chest tube. Aim 2. Perform studies to evaluate mechanical stability over time and clinical usability by cardiothoracic surgeons. Local delivery of a non-narcotic painkiller from the chest tube will reduce or remove the need to treat patients with systemic narcotics. This would reduce healthcare costs by lowering the risk of side effects and addiction potential from narcotic administration and enhancing the time of recovery. In addition, our technology could be easily adapted for delivery of other agents including anti-inflammatory or anti-thrombotic compounds. Thus, it may have wide applicability to other indwelling medical devices.