NCT06905340 Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia
| NCT ID | NCT06905340 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Nociceptive Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-05-12 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Rainer Nitzschke, MD
PRINCIPAL INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Frequently Asked Questions
Who can join the NCT06905340 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nociceptive Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06905340 currently recruiting?
Yes, NCT06905340 is actively recruiting participants. Contact the research team at r.nitzschke@uke.de for enrollment information.
Where is the NCT06905340 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT06905340 clinical trial?
NCT06905340 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Rainer Nitzschke, MD at Universitätsklinikum Hamburg-Eppendorf. The trial plans to enroll 240 participants.