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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 12, 2020

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.

Arms, Groups and Cohorts

  • The elders
    • Patients aged over 59 years old
  • The young adults
    • Patients aged from 18 to 59 years old

Clinical Trial Outcome Measures

Primary Measures

  • Pain trajectories after surgery
    • Time Frame: within 6 months
    • 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)
  • Pain trajectories after surgery
    • Time Frame: within 6 months
    • 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

Secondary Measures

  • Outcome of 6-mins-walking test
    • Time Frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
    • Walking distance of 6 minutes
  • Postoperative duration of stay in hospital
    • Time Frame: 30 days postoperation
    • The duration when patients stay in hospital after surgery.
  • Number of readmission within 30 days after surgery
    • Time Frame: Up to 30 days postoperation
    • Readmission indicates unplanned readmission after hospital discharge.
  • Complications within 30 days after surgery
    • Time Frame: Up to 30 days postoperation
    • 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).
  • The trajectories of health related quality of life(HRQoL)
    • Time Frame: 1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation
    • 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’.
  • Ambulation time
    • Time Frame: Up to 30 days postoperation
    • The first time when patients can get off of bed and walk after surgery
  • Oral feeding time
    • Time Frame: Up to 30 days postoperation
    • The first time when patients begin oral feeding after surgery

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Collaborator
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yi Feng, MD, Director of department of anesthesiology and pain management – Peking University People’s Hospital
  • Overall Official(s)
    • Feng Yi, MD, PhD, Principal Investigator, Peking University People’s Hospital
  • Overall Contact(s)
    • Feng Yi, MD, PhD, 86-010-88325590, yifeng65@sina.com

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