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

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether using a special device called the Nociception Level Index (NOL) can help doctors give the right amount of pain medication (sufentanil) during surgery. The goal is to see if this approach leads to less pain after the surgery and reduces the need for extra pain medications in the hours following the operation. The trial will focus on patients who are having elective trauma or orthopedic surgery and are receiving both general and regional anesthesia.

To be eligible for the trial, patients should be between the ages of 65 and 74 and must be undergoing specific types of surgery with a combination of anesthesia. However, those with certain heart conditions, chronic opioid misuse, or who need specialized postoperative care in an ICU will not be able to participate. If you join the trial, you can expect to be monitored closely during your surgery to see how well the NOL device works in managing your pain. This could potentially lead to a safer and more comfortable recovery experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Patients undergoing elective trauma or orthopedic surgery with a combination of general and regional anesthesia
• Exclusion Criteria:
• • 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