Status:

RECRUITING

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

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Conditions:

Nociceptive Pain

Pain, Postoperative

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Detailed Description

Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side effects of opioid administration. Underdosing of ...

Eligibility Criteria

Inclusion

  • \- Patients undergoing elective trauma or orthopedic surgery with a combination of general and regional anesthesia

Exclusion

  • 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

Key Trial Info

Start Date :

May 12 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2026

Estimated Enrollment :

240 Patients enrolled

Trial Details

Trial ID

NCT06905340

Start Date

May 12 2025

End Date

January 1 2026

Last Update

June 8 2025

Active Locations (1)

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1

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

Hamburg, Germany, 20246