Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia

Condition(s) studied

Investigational drug(s) / intervention(s)

NOL (Nociception Level Index): Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by NOL during general anesthesia in the experimental arm.

Control (Standard treatment): Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist

Study summary

General anesthesia consists of a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high-potency opioids to achieve antinociception during surgery is combining general anesthesia with regional anesthesia. Modern general anesthesia aims to avoid an overdose of opioid analgesics and reduce side effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed.

In current clinical practice, opioid dosage is usually determined by clinical judgment. However, different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the most recent commercially available nociception indices is the Nociception Level Index (NOL). Until today, there is conflicting evidence on whether guiding sufentanil administration by NOL monitoring, which is the intended use of the nociception index, affects postoperative pain level in the postanesthesia care unit (PACU), the amount of postoperatively administered opioids, and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate the clinical performance of intraoperative NOL monitoring and determine whether guiding sufentanil administration by NOL monitoring - compared to routine care - reduces either postoperative pain level in the PACU, postoperative opioid consumption in the PACU or postoperative opioid consumption in the first 24 hours after the operation in patients having trauma and orthopedic surgery with combined general and regional anesthesia.

Eligibility

Primary outcome measure(s)

• Postoperative pain level in the PACU — 1 day
  Compares the proportion of postoperative pain level (NRS=0 vs. NRS\>0) in the postanesthesia care unit (PACU) between the groups.
• Postoperative administration of opioids during the PACU stay — 1 day
  Compares the proportion of postoperative administration of opioids during the PACU stay (none vs. any) between the groups.
• Postoperative administration of opioids in the first 24 hours after the operation — 2 days
  Compares the proportion of postoperative administration of opioids in the first 24 hours after the operation (none vs. any) between the groups.

Trial sites (1)

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