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

Recruiting now · Not applicable

Conditions studied: Nociceptive Pain, Pain, Postoperative, Analgesia, Postoperative, Anesthesia Recovery Period, Opioid Use

In brief

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.

Key facts

Study ID

NCT06905340

Run by

Universitätsklinikum Hamburg-Eppendorf

People needed

240

Starts

2025-05-12

Expected to finish

2026-01-01

Last updated by the study team

2025-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing elective trauma or orthopedic surgery with a combination of general and regional anesthesia

You may not qualify if…

• Preexisting therapy with cardiac glycosides or pacemakers
• Cardiac arrhythmia (atrial fibrillation, atrioventricular block > I°)
• Chronic opioid misuse
• Intraoperative treatment with ketamine, beta-adrenergic agonists, or clonidine
• Serious peripheral or cardiac autonomic neuropathy
• Inability to specify the postoperative pain level
• Postoperative treatment in an ICU

Where it is running

• Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg Eppendorf — Hamburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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