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Completed

NCT Number: NCT06731010

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

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

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain After Thoracic Surgery Postoperative Pain, Chronic Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Evangelismos General Hospital, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Severe psychiatric conditions such as major depression, schizophrenia, or active drug abuse.
  • Preoperative analgesic therapy, which may alter EEG signals (Boord et al. 2008).
  • Diabetes mellitus 5) Chronic pain of any etiology 6) Acute pain from any cause

Treatment and study plan

Primary outcomes

  1. Postoperative pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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