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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Zhejiang University |
China,
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 |
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