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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228705
• Other study ID #: 2019PHB258-01
• Status: Recruiting
• Start date: December 13, 2019
• Est. completion date: December 12, 2020

Study information

• Verified date: January 2020
• Source: Peking University People's Hospital
• Contact: Feng Yi, MD, PhD
• Phone: 86-010-88325590
• Email: yifeng65[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly
• Model
• Pain Assessment
• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University People's Hospital	Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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