Actively Recruiting
Using the Nociception Level Index to Guide Opioid Use During Combined General and Regional Anesthesia in Trauma and Orthopedic Surgery
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-06-08
240
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate whether using the Nociception Level Index NOL to guide opioid administration during surgery can improve pain control and reduce opioid use after trauma and orthopedic surgeries performed with combined general and regional anesthesia. The study focuses on balancing effective pain relief while minimizing opioid overdose risks and side effects. It compares the NOL-guided approach to standard clinical practice in a randomized controlled trial. Participants are assigned to one of two groups in the experimental group, sufentanil doses are adjusted based on NOL readings derived from heart rate variability, skin conductance, temperature, and pulse measurements using a non-invasive finger sensor. The control group receives sufentanil according to usual clinical signs of pain and anesthesia adequacy. Both groups undergo elective trauma or orthopedic surgery combining general and regional anesthesia. During the study, participants postoperative pain levels in the recovery unit PACU and opioid use within 24 hours after surgery are carefully monitored. Researchers also assess intraoperative opioid and norepinephrine use, time to extubation, nausea and vomiting, recovery quality, and length of stay in recovery. The total study period includes the day of surgery and up to two days of post-surgery follow-up to capture these outcomes.
CONDITIONS
Brief Title
Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia
Research Team
R
Rainer Nitzschke, MD
A
Annika Zoller
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