Using the Nociception Level Index to guide opioid dosing during combined regional and general anesthesia
Nociception Level Index-Guided Intraoperative Opioids in Patients With a Combination of General and Regional Anesthesia
This trial tests whether using a Nociception Level Index (NOL) monitor to guide opioid dosing during combined general and regional anesthesia can reduce opioid use and side effects for adults having elective trauma or orthopedic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06905340 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective trauma or orthopedic surgery who receive combined general and regional anesthesia will have intraoperative opioid dosing guided either by the Nociception Level Index (NOL) monitor or by standard clinical judgment. In the NOL arm, anesthesiologists will adjust opioid administration in real time based on the monitor's readings, while the control arm receives usual care. Outcomes include intraoperative and postoperative opioid consumption, postoperative pain levels, recovery markers such as nausea and hemodynamic stability, and length of stay. Patients with pacemakers, significant arrhythmias, chronic opioid misuse, or those requiring postoperative ICU care are excluded.
Who should consider this trial
Good fit: Adults undergoing elective trauma or orthopedic surgery with combined general and regional anesthesia who do not have pacemakers, serious arrhythmias, chronic opioid misuse, or severe autonomic neuropathy are ideal candidates.
Not a fit: Patients with pacemakers, significant cardiac arrhythmias, chronic opioid misuse, severe autonomic neuropathy, those receiving intraoperative ketamine/beta-agonists/clonidine, or those needing postoperative ICU care are excluded and would not be expected to benefit from this approach.
Why it matters
Potential benefit: If successful, NOL-guided dosing could lower intra- and postoperative opioid doses and related side effects while maintaining effective pain control and faster recovery.
How similar studies have performed: Previous trials of nociception monitoring, including NOL, have produced mixed results, with some showing reduced opioid use and fewer side effects and others showing no clear advantage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Rainer Nitzschke, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Rainer Nitzschke, MD
- Email: r.nitzschke@uke.de
- Phone: +4915222815884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.