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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03761576
Other study ID # 2018PHB191-02
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 21, 2018
Est. completion date October 31, 2023

Study information

Verified date October 2022
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date October 31, 2023
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Yi Feng, MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary acute pain numerical rating scale(NRS)>3 the third day of the surgery
Primary chronic pain numerical rating scale(NRS)>3 the second month of the surgery
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