Application of Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Adult Patients Undergoing Major Thoracic Surgery

Completed

• Conditions: Postoperative Pain, Acute; Postoperative Pain, Chronic; Postoperative Pain After Thoracic Surgery

• Registration Number: NCT06731010
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

The primary aim of this study is to explore the relationship between alpha electroencephalographic oscillations, particularly Peak Alpha Frequency (PAF), pupillometry, intraoperative Nociception Level (NOL) and postoperative pain following major thoracic surgeries.

Goals to investigate the use of preoperative EEG as a biomarker for the prediction of postoperative pain to investigate the use of pupillometry in postoperative pain prediction and evaluation to test intraoperative NOL as a predicting factor of postoperative pain

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer.

Exclusion Criteria

• 1. Severe neurological disorders (e.g. dementia) that could interfere with EEG recordings or pain testing.

  2. Severe psychiatric conditions such as major depression, schizophrenia, or active drug abuse.

  3. Preoperative analgesic therapy, which may alter EEG signals (Boord et al. 2008).

  4. Diabetes mellitus 5) Chronic pain of any etiology 6) Acute pain from any cause

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Pain intensity was recorded immediately postoperatively in the Post-Anesthesia Care Unit (PACU), as well as at 24, 48, and 72 hours after the surgery. Chronic postoperative pain was assessed both one month and three months after surgery.	Pain intensity in patients was assessed postoperatively using the Numeric Rating Scale (NRS), specifically the Eleven-point NRS (NRS 0-10). Responses were categorized as follows: 0 : no pain, scores from 1 to 3 indicated mild pain, a score of 4-6 represented moderate pain, and scores of 7 or higher signified severe pain.Patients' postoperative late pain was assessed using NRS and the DN4 index. The DN4 (Douleur Neuropathique 4 questions) is a validated questionnaire used to diagnose neuropathic pain. It is utilized to evaluate postoperative pain and assess symptoms related to neuropathic pain, such as the spread of pain and alterations in sensory perception

Trial Locations

Locations (2)

Evangelismos General Hospital; 🇬🇷 Athens, Attiki, Greece

National and Kapodistrian University of Athens; 🇬🇷 Athens, Attiki, Greece