intraoIntraoperative nociception and patient outcomeInvestigation of the NOL (Nociception Level Index) in patients with surgical, urological, gynecological, or orthopedic/trauma surgery procedures under general anesthesiaperative nociception and patient-outcome

Recruiting

• Conditions: R52; Pain, not elsewhere classified

• Registration Number: DRKS00032578
• Lead Sponsor: niklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Consenting adults (age = 18)
- signed declaration of consent
- planned surgical intervention under general anesthesia

Exclusion Criteria

- insufficient knowledge of German
- Surgery under regional anesthesia
- Current pregnancy
- Patient is confused/has difficulties in understanding
- Cardiac arrhythmias (including absolute arrhythmia in atrial fibrillation, pacemaker-dependent patients)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to analyze the association between intraoperative nociception (Nociception Level Index, NOL index; PMD200, Medasense Biometrics Ltd.) and patient outcome (pain intensity, pain interference, side effects) as a composite score on postoperative day 1

Secondary Outcome Measures

Name	Time	Method
Influence of intraoperative nociception on chronic postoperative pain (FU 3 months, FU 6 months).<br>Individual domains of the QUIPS questionnaire (pain intensity, impairment, side effects)