CClinicalTrials.gg
Status unknownNCT04228705Updated Jan 14, 2020

Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders

An observational study in Postoperative Pain, Pain Assessment and Elderly, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
01

Study summary

This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.

Read the detailed description

This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.

02

Conditions studied

  • Postoperative Pain
  • Pain Assessment
  • Elderly
  • Model

Browse trials for

03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients aged 18 years or older undergoing general or regional anesthesia of any procedures, mainly include: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.

Inclusion criteria

  • 18 years or older
  • Undergoing general or regional anesthesia
  • Hospitalized for at least 24 hours after surgery
  • Able to give informed consent
  • Able to read and write

Exclusion criteria

Exclusion Criteria:

  • Existing diagnoses of psychiatric or neurologic pathology
  • A history of substance abuse
  • Admitted to ICU after surgery
  • Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • The elders

    Patients aged over 59 years old

  • The young adults

    Patients aged from 18 to 59 years old

06

What researchers measure

Primary outcomes

  1. Pain trajectories after surgery

    The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)

    Time frame: within 6 months

  2. Pain trajectories after surgery

    The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with Brief Pain Inventory -Short Form (BPI-SF) within 6 months

    Time frame: within 6 months

Secondary outcomes

  1. Outcome of 6-mins-walking test

    Walking distance of 6 minutes

    Time frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation

  2. Postoperative duration of stay in hospital

    The duration when patients stay in hospital after surgery.

    Time frame: 30 days postoperation

  3. Number of readmission within 30 days after surgery

    Readmission indicates unplanned readmission after hospital discharge.

    Time frame: Up to 30 days postoperation

  4. Complications within 30 days after surgery

    Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient).

    Time frame: Up to 30 days postoperation

  5. The trajectories of health related quality of life(HRQoL)

    The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score \< 0 is considered as health state that is 'worse than death'.

    Time frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation

  6. Ambulation time

    The first time when patients can get off of bed and walk after surgery

    Time frame: Up to 30 days postoperation

  7. Oral feeding time

    The first time when patients begin oral feeding after surgery

    Time frame: Up to 30 days postoperation

07

Study locations

1 of 1 sites recruiting
  • Peking University People's Hospital
    Beijing, Beijing 100044, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04228705
Lead sponsor
Peking University People's Hospital
Collaborators
Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University
Responsible party
Yi Feng, MD (Director of department of anesthesiology and pain management, Peking University People's Hospital) — Principal investigator
First posted
Jan 14, 2020
Start date
Dec 13, 2019
Primary completion
Dec 12, 2020 (estimated)
Completion
Dec 12, 2020 (estimated)
Last update
Jan 14, 2020

Study contacts

Feng Yi, MD, PhD
Contact
yifeng65@sina.com
86-010-88325590
Feng Yi, MD, PhD
principal investigator · Peking University People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion