Systemic intravenous lidocaine for perioperative pain management: a call for changing indications in the package sheet.

Obtaining adequate analgesia after major surgery is a problematic issue and postoperative pain still imposes a major burden of suffering on surgical patients [1].

Intravenous patient-controlled opioids and epidural local anesthetics, the mainstay modalities in acute surgical pain treatment, expose the patients to potentially serious side effects [2].

The perioperative administration of systemic intravenous lidocaine has been shown to be an effective method in postoperative pain management with a favorable effect on pain scores, opioid consumption and recovery after surgery without any clear evidence of harm [3, 4]. Although the current literature is univocal about its efficacy and safety [5,6,7], the systemic intravenous use for perioperative pain management is still not mentioned in the lidocaine package sheet.

We believe that this fact, leading health practitioners to deal with the risks of an off-label prescription, hampers the diffusion of an effective, safe, simple, cheap and widely accessible method of perioperative pain control.

With millions of major surgical interventions carried out every year it is reasonable to speculate that pharmaceutical companies will derive a consistent benefit from expanding, with the due warnings of potential side effects, the lidocaine indications as we here propose.

Alternatively, a previous Italian experience in the field of pediatric anesthesia showed that a process leading to formal authorization for off-label uses can be obtained for drugs for which evidence of efficacy and safety in purposes different from the ones cited in the product label exists in the scientific literature [8].

Additionally, researchers, backed by scientific societies, could collaborate with donors in implementing large clinical trials with the aim of definitely consolidate the already existing evidence.

In conclusion, while we advocate further high-quality research on the subject we suggest that regulating bodies, scientific societies and industries should as soon as possible take steps to include the systemic intravenous use for perioperative analgesia among the lidocaine formal indications.