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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Postoperative Pain, Pain Assessment, Elderly, Model

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The elders<br>Patients aged over 59 years old | |
| The young adults<br>Patients aged from 18 to 59 years old | |

What is the study measuring?
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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 |