Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06905340

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

Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-06-08

240

Participants Needed

1

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective trauma or orthopedic surgery with a combination of general and regional anesthesia
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg Eppendorf

Hamburg, Germany, 20246

Actively Recruiting

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Research Team

R

Rainer Nitzschke, MD

CONTACT

A

Annika Zoller

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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