Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers.

Abstract

Analgesia might be evaluated with simple changes in vital signs, a non-specific and non-sensitive method. Heart rate variability (HRV) correlates with autonomous nervous system activity and can be used to evaluate painful stimuli. Heart rate variability is then transformed into a numeric scale called the analgesia nociception index (ANI), where higher values represent predominant parasympathetic tone, thus low nociception. Under general anesthesia, the ANI decreases following painful stimuli and increases after administration of analgesia, but significant interindividual variability is present. The goal of the present study was to evaluate the ANI as a pain index in healthy awake volunteers. Following research ethics board approval, participants were positioned supine in a calm operating room. The participants' vital signs and ANI were monitored. After evaluation of all parameters without any stimulation, 23 volunteers received a 2Hz electrical stimulus at the wrist with increasing current intensity from 0-30mA (5mA increments). The current was kept constant for three minutes at each level, and the volunteers rated their pain on a numeric rating scale (NRS) every minute. The Pearson correlation coefficient and linear regression were used to analyze the relationship between the ANI and the NRS score. The ANI absolute values and the variations from baseline were both analyzed. There was a very weak negative correlation between the NRS score and ANImean (Pearson, -0.089; 95% confidence interval [CI], -0.192 to -0.014; P=0.045) and between the NRS score and ∆ANImean (Pearson, -0.174; 95% CI, -0.272 to -0.072; P<0.001; regression slope, -0.586; 95% CI, -0.930 to -0.243; P<0.001). Heart rate, blood pressure, and respiratory rate did not vary significantly throughout the study. These findings provide little evidence to support use of the ANI in awake subjects or in awake patients such as those in the emergency room or in the intensive care unit. Nevertheless, based on an important difference between the expected correlation and the real correlation between the ANI and the NRS scores found in our results, the present study might be underpowered. Studies with a larger sample size would be required to enable firm conclusions about the clinical utility of the ANI in this population of awake volunteers as well as in awake patients. This study was registered with ClinicalTrials.gov (NCT02589093).