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Trial record 1 of 1 for:    NCT03761576
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The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT03761576
Recruitment Status : Unknown
Verified December 2018 by Yi Feng, MD, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : December 3, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yi Feng, MD, Peking University People's Hospital

Brief 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 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.

Condition or disease
Acute Pain Chronic Pain Thoracic Surgery Electroencephalography Brain Mechanism

Detailed Description:
Patients after thoracic 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 thoracic 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 thoracic 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 thoracic surgery, and give them reasonable intervention in time, and provide effective solutions for the acute pain and chronic pain after thoracic surgery.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Role of Cognitive Function and Electroencephalography on Acute and Chronic Pain After Thoracic Surgery
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  1. acute pain [ Time Frame: the third day of the surgery ]
    numerical rating scale(NRS)>3

  2. chronic pain [ Time Frame: the second month of the surgery ]
    numerical rating scale(NRS)>3



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100
Criteria

Inclusion Criteria:

  • Thoracoscopic mediastinal mass resection,wedge resection or lobectomy 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761576


Contacts
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Contact: Fei Gao, MD 08618588217261 gaofei19780318@sina.com
Contact: Qi Han 08601088325581 hanqi1991@163.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yi Feng, MD    08601088325590    yifeng65@sina.com   
Sponsors and Collaborators
Yi Feng, MD
Investigators
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Study Chair: Yi Feng, MD Peking University People's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yi Feng, MD, director of department of anesthesiology and painmanagement, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03761576    
Other Study ID Numbers: 2018PHB191-01
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Acute Pain
Pain
Neurologic Manifestations