Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial

Rivka Fuica, Carlos Krochek, Rachel Weissbrod, Dimitri Greenman, Andres Freundlich, Yaacov Gozal, Rivka Fuica, Carlos Krochek, Rachel Weissbrod, Dimitri Greenman, Andres Freundlich, Yaacov Gozal

Abstract

The Nociception Level index (NOL™) is a multiparameter index, based on artificial intelligence for the monitoring of nociception during anesthesia. We studied the influence of NOL-guided analgesia on postoperative pain scores in patients undergoing major abdominal surgery during sevoflurane/fentanyl anesthesia. This study was designed as a single-center, prospective randomized, controlled study. After Institutional Review Board approval and written informed consent, 75 ASA 1-3 adult patients undergoing major abdominal surgery, were randomized to NOL-guided fentanyl dosing (NOL) or standard care (SOC) and completed the study. The sevoflurane target MAC range was 0.8-1.2. In the NOL-guided group (N = 36), when NOL values were > 25 for at least 1 min, a weight adjusted fentanyl bolus was administered. In the control group (N = 39) fentanyl administration was based on hemodynamic indices and clinician judgement. After surgery, pain, was evaluated using the Numerical Rating Scale (NRS) pain scale, ranging from 0 to 10, at 15 min intervals for 180 min or until patient discharge from the PACU. Median postoperative pain scores reported were 3.0 [interquartile range 0.0-5.0] and 5.0 [3.0-6.0] at 90 min in NOL-guided and control groups respectively (Bootstrap corrected actual difference 1.5, 95% confidence interval 0.4-2.6). There was no difference in postoperative morphine consumption or intraoperative fentanyl consumption. Postoperative pain scores were significantly improved in nociception level index-guided patients. We attribute this to more objective fentanyl dosing when timed to actual nociceptive stimuli during anesthesia, contributing to lower levels of sympathetic activation and surgical stress. Clinicaltrials.gov identifier: NCT03970291 date of registration May 31, 2019.

Keywords: Artificial Intelligence; Nociception; Nociception level-guided analgesia; Opioid; Personalized Anesthesia; Postoperative pain.

Conflict of interest statement

RW is an employee of Medasense Biometrics. None of the other authors report any conflicts of interest.

Rivka Fuica, Carlos Krochek, Dimitri Greenman, Andres Freundlich and Yaacov Gozal declare no competing interests. Rachel Weissbrod is a fulltime employee of Medasense Biometrics, the study sponsor.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The PMD-200 Monitor
Fig. 2
Fig. 2
Patient flow chart
Fig. 3
Fig. 3
PACU pain Scores at 90 minutes with breakdown by surgery type
Fig. 4
Fig. 4
PACU pain score trajectories in the NOL guided and SOC groups

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Source: PubMed

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