Using the Nociception Level Index to guide opioid dosing during combined regional and general anesthesia
Official title: Nociception Level Index-Guided Intraoperative Opioids in Patients With a Combination of General and Regional Anesthesia
Run by Universitätsklinikum Hamburg-Eppendorf · NCT06905340 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Status | Recruiting |
| Started | May 12, 2025 |
| Main results expected | December 2025 |
| Study ends | January 2026 |
| Registry record updated | June 8, 2025 |
| Trial ID | NCT06905340 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Dexa vs Dexmedetomidine with Bupivacaine in TAP Block for Laparotomy Analgesia
This study tests whether adding dexamethasone or dexmedetomidine to bupivacaine in a TAP block improves postoperative pain control after laparotomy.
-
Autonomic Nerve Blockade to Reduce Pain and Nausea After Bariatric Surgery
This study tests whether an autonomic nerve block given during bariatric surgery can lessen pain and nausea and decrease the need for anti-nausea and pain medicines in the first 72 hours after sleeve gastrectomy or gastric bypass.
-
Comparing pain relief methods after knee surgery
This study is testing which pain relief method, Adductor Canal Block or Genicular Nerve Block, works better for people aged 18-72 after knee surgery.
-
Comparing ketamine delivery methods for postoperative pain management in orthopedic surgery
This study is testing whether giving ketamine through an IV or a patient-controlled pump works better for managing pain after major orthopedic surgery in adults.
-
Comparing pain relief methods after lumbar fusion surgery
This study tests whether a new way of giving local anesthesia during lumbar fusion surgery can help patients feel less pain and use fewer opioids compared to the traditional method.
-
Smart opioid dispenser and app for patients having a one-level lumbar discectomy or laminectomy
This test tries a locked opioid-dispensing device plus a smartphone app to help adults having a one-level lumbar discectomy or laminectomy who are opioid-naive or occasional users take oxycodone more safely after discharge.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.