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

December 11, 2024 updated by: Chrysanthi Barba, National and Kapodistrian University of Athens

Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in 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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 10676
        • Evangelismos General Hospital
      • Athens, Attiki, Greece, 11527
        • National and Kapodistrian University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to Evangelismos General Hospital in Athens, Greece, for lung cancer treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 298792022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in publications: Only the individual-level data that directly support the published results or findings (e.g., data used in statistical analyses that led to conclusions). Anonymized data .

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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