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

NCT06731010 | Completed

• 1 other identifier: 298792022
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

Postoperative Pain, Acute; Postoperative Pain, Chronic; Postoperative Pain After Thoracic Surgery

Keywords

Postoperative pain; Pupillometry; EEG; Peak alpha frequency (PAF); Nociception Level Index (NOL)

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (2)

Evangelismos General Hospital

Athens, Attica, 10676, Greece

Location

National and Kapodistrian University of Athens

Athens, Attica, 11527, Greece

Location

Related Publications (5)

• Koschmieder KC, Funcke S, Shadloo M, Pinnschmidt HO, Greiwe G, Fischer M, Nitzschke R. Validation of three nociception indices to predict immediate postoperative pain before emergence from general anaesthesia: a prospective double-blind, observational study. Br J Anaesth. 2023 Apr;130(4):477-484. doi: 10.1016/j.bja.2022.11.024. Epub 2023 Jan 4.

  PMID: 36609057 BACKGROUND

• Fang PP, Wu JQ, Tang LL, Gao S, Liu XS. The association between perioperative pupillary parameters and postoperative acute pain: A pilot cross-sectional study. Pain Pract. 2022 Mar;22(3):322-328. doi: 10.1111/papr.13084. Epub 2021 Oct 26.

  PMID: 34662477 BACKGROUND

• Furman AJ, Prokhorenko M, Keaser ML, Zhang J, Chen S, Mazaheri A, Seminowicz DA. Sensorimotor Peak Alpha Frequency Is a Reliable Biomarker of Prolonged Pain Sensitivity. Cereb Cortex. 2020 Nov 3;30(12):6069-6082. doi: 10.1093/cercor/bhaa124.

  PMID: 32591813 BACKGROUND

• Furman AJ, Meeker TJ, Rietschel JC, Yoo S, Muthulingam J, Prokhorenko M, Keaser ML, Goodman RN, Mazaheri A, Seminowicz DA. Cerebral peak alpha frequency predicts individual differences in pain sensitivity. Neuroimage. 2018 Feb 15;167:203-210. doi: 10.1016/j.neuroimage.2017.11.042. Epub 2017 Nov 21.

  PMID: 29175204 BACKGROUND

• Millard SK, Furman AJ, Kerr A, Seminowicz DA, Gao F, Naidu BV, Mazaheri A. Predicting postoperative pain in lung cancer patients using preoperative peak alpha frequency. Br J Anaesth. 2022 Jun;128(6):e346-e348. doi: 10.1016/j.bja.2022.03.006. Epub 2022 Apr 4. No abstract available.

  PMID: 35393099 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anaesthesiology Resident GH Evangelismos

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GR (2)