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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Elderly; Model; Pain Assessment

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.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Feng Yi, MD, PhD; Phone Number: 86-010-88325590; Email: yifeng65@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Yi Feng, MD; Phone Number: 08601088325590; Email: yifeng65@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
The elders; Patients aged over 59 years old
The young adults; Patients aged from 18 to 59 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	within 6 months
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	within 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Chinese PLA General Hospital; Zhejiang University; First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Feng Yi, MD, PhD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Anticipated): December 12, 2020
• Study Completion (Anticipated): December 12, 2020

Study Registration Dates

• First Submitted: January 12, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019PHB258-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No