Acute PainNCT03761576
The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery
An observational study of Acute Pain and Chronic Pain, run by Yi Feng, MD at 1 site in China.
Trial summary
The project will apply the methods of clinical observation experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain, Chronic Pain, Thoracic Surgery
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2018to 31 Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100
Who may be able to join
- surgery were planned to be performed under general anesthesia
- Educational attainment beyond high school
- Require postoperative analgesia and sign the informed consent
Who cannot join
- with mental illness or a family history of mental illness
- Patients with cerebrovascular diseases or cerebrovascular accidents
- Previous head trauma history or craniotomy
- Using central analgesics, opioids addiction
- With a history of alcoholism
- do not understand the numerical rating scale(NRS) score and can not use patient-controlled analgesia(PCA）
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
The project will apply the methods of clinical observation experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after surgery.
Read the detailed description
Patients after surgery are liable to suffer from moderate to severe acute pain and refractory chronic pain, which would lead to serious somatic and psychological suffering. Its successful treatment is a great challenge for pain physicians. To date, the mechanism of pain chronification after surgery remains unclear. Further, it is still lack of efficient preventive and therapeutic measures for this chronic pain. The project will apply the methods of clinical observation and animal experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after thoracic surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after thoracic surgery. The project will be able to determine the relationships between the degree of recovery of early postoperative cognitive function, as well as preoperative resting-state EEG indices and postoperative acute pain and chronic pain, and clarify the neural mechanism of acute pain and chronic pain after surgery. The expected outcomes of this study can contribute to early identification of the patients who are liable to develop into acute pain and chronic pain after surgery, and give them reasonable intervention in time, and provide effective solutions for the acute pain and chronic pain after surgery.
- Medical subject headings
- Acute Pain, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
acute pain
numerical rating scale(NRS)>3
Measured: the third day of the surgery
chronic pain
numerical rating scale(NRS)>3
Measured: the second month of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start21 Dec 2018
- Primary completion31 Mar 2021
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Feng, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Feng, MD, Peking University People's Hospital
- Investigators
- Yi Feng, MD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761576
- Sponsor's protocol ID
- 2018PHB191-02
- Status last verified
- Oct 2022
- First submitted
- 30 Nov 2018
- Last updated
- 18 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang YQ, Li YR, Han Q, Gao F, Feng Y. Evaluation of dynamic brain function in patients with different degrees of chronic pain by EEG microstate analysis. BMC Anesthesiol. 2025 Oct 14;25(1):491. doi: 10.1186/s12871-025-03326-1.
PubMed 41087907Han Q, Yue L, Gao F, Zhang L, Hu L, Feng Y. The Prediction of Acute Postoperative Pain Based on Neural Oscillations Measured before the Surgery. Neural Plast. 2021 Apr 9;2021:5543974. doi: 10.1155/2021/5543974. eCollection 2021.
PubMed 33897775
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery
- ClinicalTrials.gov ID
- NCT03761576
- Acronym / sponsor ID
- 2018PHB191-02
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yi Feng, MDUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 3 Dec 2018 (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 project will apply the methods of clinical observation experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after surgery.
Detailed description
Patients after surgery are liable to suffer from moderate to severe acute pain and refractory chronic pain, which would lead to serious somatic and psychological suffering. Its successful treatment is a great challenge for pain physicians. To date, the mechanism of pain chronification after surgery remains unclear. Further, it is still lack of efficient preventive and therapeutic measures for this chronic pain. The project will apply the methods of clinical observation and animal experiment, (1) to collect the cognitive function data preoperatively and early postoperatively, as well as the pain score data at multiple time points pre- and postoperatively, and to observe the role of the degree of recovery of early postoperative cognitive function on acute pain and chronic pain after thoracic surgery. (2) to collect the resting-state electroencephalography (EEG) preoperatively, and to assess the role of EEG index system on the prediction of the degree of recovery of early postoperative cognitive function as well as the acute pain and chronic pain after thoracic surgery. The project will be able to determine the relationships between the degree of recovery of early postoperative cognitive function, as well as preoperative resting-state EEG indices and postoperative acute pain and chronic pain, and clarify the neural mechanism of acute pain and chronic pain after surgery. The expected outcomes of this study can contribute to early identification of the patients who are liable to develop into acute pain and chronic pain after surgery, and give them reasonable intervention in time, and provide effective solutions for the acute pain and chronic pain after surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100
Key inclusion criteria (3 listed)
- surgery were planned to be performed under general anesthesia
- Educational attainment beyond high school
- Require postoperative analgesia and sign the informed consent
Key exclusion criteria (6 listed)
- with mental illness or a family history of mental illness
- Patients with cerebrovascular diseases or cerebrovascular accidents
- Previous head trauma history or craniotomy
- Using central analgesics, opioids addiction
- With a history of alcoholism
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
acute pain
Time frame: the third day of the surgery
numerical rating scale(NRS)>3
chronic pain
Time frame: the second month of the surgery
numerical rating scale(NRS)>3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 41087907Zhang YQ, Li YR, Han Q, Gao F, Feng Y. Evaluation of dynamic brain function in patients with different degrees of chronic pain by EEG microstate analysis. BMC Anesthesiol. 2025 Oct 14;25(1):491. doi: 10.1186/s12871-025-03326-1.
- Derived from this study: PubMed 33897775Han Q, Yue L, Gao F, Zhang L, Hu L, Feng Y. The Prediction of Acute Postoperative Pain Based on Neural Oscillations Measured before the Surgery. Neural Plast. 2021 Apr 9;2021:5543974. doi: 10.1155/2021/5543974. eCollection 2021.
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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.
Yi Feng, MD study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Chronic Pain, run by Yi Feng, MD at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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?
acute pain (time frame: the third day of the surgery). The study lists 2 primary outcomes in all. 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 NCT03761576, which also lists 2 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 18 Oct 2022.