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

Study on Comprehensive Strategy of Perioperative Pain Prevention and Treatment in Elderly Patients -- Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04228705
Enrollment
6000
Registered
2020-01-14
Start date
2019-12-13
Completion date
2020-12-12
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Model, Pain Assessment, Postoperative Pain

Brief 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.

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.

Interventions

None listed

Sponsors

Chinese PLA General Hospital
CollaboratorOTHER
First Affiliated Hospital of Guangxi Medical University
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain trajectories after surgerywithin 6 monthsThe 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)

Secondary

MeasureTime frameDescription
Outcome of 6-mins-walking test1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperationWalking distance of 6 minutes
Number of readmission within 30 days after surgeryUp to 30 days postoperationReadmission indicates unplanned readmission after hospital discharge.
Complications within 30 days after surgeryUp to 30 days postoperationComplications 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).
Postoperative duration of stay in hospital30 days postoperationThe duration when patients stay in hospital after surgery.
Ambulation timeUp to 30 days postoperationThe first time when patients can get off of bed and walk after surgery
Oral feeding timeUp to 30 days postoperationThe first time when patients begin oral feeding after surgery
The trajectories of health related quality of life(HRQoL)1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperationThe 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'.

Countries

China

Contacts

Primary ContactFeng Yi, MD, PhD
yifeng65@sina.com86-010-88325590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026