NCT03761576

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

November 30, 2018

Last Update Submit

October 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • acute pain

    numerical rating scale(NRS)\>3

    the third day of the surgery

  • chronic pain

    numerical rating scale(NRS)\>3

    the second month of the surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100

You may qualify if:

  • surgery were planned to be performed under general anesthesia
  • Educational attainment beyond high school
  • Require postoperative analgesia and sign the informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (2)

  • 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.

  • Han 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.

MeSH Terms

Conditions

Acute PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yi Feng, MD

    Peking University People's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director of department of anesthesiology and painmanagement

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 3, 2018

Study Start

December 21, 2018

Primary Completion

March 31, 2021

Study Completion

October 31, 2023

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations