Postoperative Pain, AcuteNCT06731010
Application of Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Adult Patients Undergoing Major Thoracic Surgery
An observational study of Postoperative Pain, Acute and Postoperative Pain, Chronic, run by National and Kapodistrian University of Athens at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute, Postoperative Pain, Chronic, Postoperative Pain After Thoracic Surgery
- How many people
- 20 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Nov 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Evangelismos General Hospital in Athens, Greece, for lung cancer treatment.
Who may be able to join
- Patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Evangelismos General Hospital
Athens, Attica, 10676
National and Kapodistrian University of Athens
Athens, Attica, 11527
About this study
Official title: 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
- 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)
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Nov 2022
- Primary completion1 May 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrysanthi Barba, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731010
- Sponsor's protocol ID
- 298792022
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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 .
Publications
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.
PubMed 36609057Fang 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.
PubMed 34662477Furman 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.
PubMed 32591813Furman 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.
PubMed 29175204Millard 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.
PubMed 35393099
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neurophysiological Methods in Predicting and Evaluating Postoperative Pain in Patients Undergoing Major Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06731010
- Acronym / sponsor ID
- 298792022
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Evangelismos General Hospital in Athens, Greece, for lung cancer treatment.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older scheduled for open lung lobectomy due to early-stage lung cancer.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 36609057Koschmieder 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.
- Background: PubMed 34662477Fang 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.
- Background: PubMed 32591813Furman 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.
- Background: PubMed 29175204Furman 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.
- Background: PubMed 35393099Millard 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.
- Individual participant dataSharing planned: Yes. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, Acute and Postoperative Pain, Chronic, run by National and Kapodistrian University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731010, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.