Ex vivo animal-model assessment of a non-invasive system for loss of resistance detection during epidural blockade

During recent decades epidural analgesia has gained widespread recognition in many applications. In this complex procedure, anaesthetist uses a specific needle to inject anesthetic into the epidural space. It is crucial the appropriate insertion of the needle through inhomogeneous tissues placed between the skin and the epidural space to minimize anesthetic-related complications (e.g., nausea, headache, and dural puncture). Usually, anaesthetists perform the procedure without any supporting tools, and stop pushing the syringe when they sense a loss of resistance (LOR). This phenomenon is caused by the physical properties of the epidural space: the needle breaks the ligamentum flavum and reaches the epidural space, in this stage the anaesthetist perceives a LOR because the epidural space is much softer than the ligamentum flavum. To support the clinician in this maneuver we designed a non-invasive system able to detect the LOR by measuring the pressure exerted on the syringe plunger to push the needle up to the epidural space. In a previous work we described the system and its assessment during in vitro tests. This work aims at assessing the feasibility of the system for LOR detection on a more realistic model (ex vivo pig model). The system was assessed by analyzing: its ability to hold a constant value (saturation condition) during the insertion of the needle, and its ability to detect the entrance within the epidural space by a decrease of the system's output. Lastly, the anaesthetist was asked to assess how the ex vivo procedure mimics a clinical scenario. The system reached the saturation condition during the needle insertion; this feature is critical to avoid false positive during the procedure. However, it was not easy to detect the entrance within the epidural space due to its small volume in the animal model. Lastly, the practitioner found real the model, and performed the procedures in a conventional manner because the system did not influence his actions.