Asleep or Awake: Rethinking “Safety”

The article by Taenzer et al 1 in this issue of Regional Anesthesia and PainMedicine provides important information concerning the management of pediatric patients undergoing regional anesthesia, prompting us to grapple with the critical question of safety in anesthesia. Although the study strongly supports the fact that performing a block in an anesthetized child is certainly not unsafe, it encourages us to consider these findings in a broader context: The word “safety” refers, of course, to “safety of the patient,” but as human beings, we cannot deny that we constantly consider our own safety, too, especially from a medicolegal point of view. Even the term “patient safety” is ambiguous. All regional anesthetic procedures require the injection of a local anesthetic in the vicinity of sensory nerve fibers, either enclosed in a nerve trunk, a plexus, or near the spinal cord, and this needle puncture necessarily produces some degree of tissue damage and, for those fearing needle punctures, may elicit adverse reactions. Furthermore, concerns about safety apply not only to “histological” lesions but also to emotional lesions. Is the occurrence of long-lasting nightmares, phobias, or occasionally the development of psychiatric disorders resulting from the fear of needles, a minor issue if the technique does not result in any observable anatomical lesions? Neurological lesions, especially paraplegia, are unacceptable, and all possible precautions should be taken to avoid such consequences, but what exactly are “all possible precautions”? Since the end of the 20th century, we have come to believe that evidence-based medicine is the way forward. The individual perception of sound decisions is no longer deemed appropriate, and good practice should be evaluated in large cohorts of patients who are treated in as much the sameway as possible. Evenwith its limitations, evidence-based medicine undoubtedly represents a considerable improvement in evaluating our practice and promoting safety, but it is most fruitful for events occurring frequently, for which well-designed studies involving a rather limited number of patients allow definitive conclusions concerning safety of management. For rare and extremely rare events, definitive statements about the “safest technique” will never be possible due to the needed size of the study population. This is particularly true regarding the eternally asked question about the safety of block procedures performed in fully awake, sedated, or truly anesthetized patients, especially pediatric patients. Still, in 1996 Giaufré et al published amulti-institutional prospective study on 85,412 pediatric anesthetics of which 24,409 involved a regional block, more