- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761576
The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Surgery
October 15, 2022 updated by: Yi Feng, MD
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.
Study Overview
Status
Enrolling by invitation
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 Type
Observational
Enrollment (Anticipated)
100
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
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Peking University People's Hospital
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
100
Description
Inclusion Criteria:
- surgery were planned to be performed under general anesthesia
- Educational attainment beyond high school
- Require postoperative analgesia and sign the informed consent
Exclusion Criteria:
- 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)
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 |
---|---|---|
acute pain
Time Frame: the third day of the surgery
|
numerical rating scale(NRS)>3
|
the third day of the surgery
|
chronic pain
Time Frame: the second month of the surgery
|
numerical rating scale(NRS)>3
|
the second month of the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
December 21, 2018
Primary Completion (Actual)
March 31, 2021
Study Completion (Anticipated)
October 31, 2023
Study Registration Dates
First Submitted
November 30, 2018
First Submitted That Met QC Criteria
November 30, 2018
First Posted (Actual)
December 3, 2018
Study Record Updates
Last Update Posted (Actual)
October 18, 2022
Last Update Submitted That Met QC Criteria
October 15, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018PHB191-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device 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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