Clinical trial NCT06731010: Application of Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Adult Patients Undergoing Major Thoracic Surgery
Official title: Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Patients Undergoing Major Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Evangelismos General Hospital in Athens, Greece, for lung cancer treatment.

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


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos General Hospital
state: Attiki
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
state: Attiki
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.