Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
NCT Number: NCT05372406
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 chronic postsurgical pain in elderly patients and to establish an early-warning models 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.
Based on the database, the investigators intend to explore:
* Perioperative risk assessment methods and early warning models for elderly patients; * Practical, safe, and effective risk prevention and control system through subsequent studies.
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Notify Me65 year and older
All sexes
Observational
Beijing, Beijing Municipality, 100853, China
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 chronic postsurgical pain in elderly patients and to establish an early-warning model of chronic postsurgical pain in elderly patients, so as to improve the ability of assessing the risks of chronic postsurgical pain in elderly patients and providing an early warning.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 3 months postoperation
Pain intensity was assessed using a numerical rating scale (NRS) from 0 to 10, with zero representing no pain and 10 representing worst imaginable pain. The worst pain intensity was then categorized into two groups: no or mild pain (NRS from 0 to 3) and moderate to severe pain (NRS from 4 to 10).
Time frame: Up to 3 months postoperation
It measured pain location in the body; pain intensity on an 11-point numerical rating scale (NRS; 0 represents "no pain" and 10 the "worst pain imaginable"); analgesic intake; perception of analgesic relief; and pain interference with daily life on an 11-point NRS (0 "does not interfere and 10"completely interferes") indistinct dimensions (general activity, mood, walking, work, relations with others, sleep, and enjoyment of life). Higher scores represent higher levels of pain interference.
Time frame: within 30 days prior to surgery
The PCS consists of 13 items, and each item is answered with a numeric value between 0 and 4; 0 corresponding to "not at all", and four corresponded to "all the time". Higher scores indicate a higher level of pain catastrophizing, the Chinese version of the PCS has demonstrated a good reliability and validity (Cronbach's alpha was 0.87 and the ICC was 0.97)
Time frame: within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation
The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D-5L)taken over 3 months(days 1, 3, 7, 30, 90;Day 0 is the day of surgery). The EQ-5D-5L 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'.
Time frame: within 30 days prior to surgery , Up to 3 months postoperation
Comprised by 2 subscales used to measure anxiety and depression through 7 items each. Subscale scores range from 0 to 21 and result from the sum of each item (Likert scale ranging from 0 to 3). Higher scores correspond to higher levels of anxiety and depression.
Time frame: within 30 days prior to surgery ,Up to 3 months postoperation
Frailty was assessed within 30 days prior to surgery using the FRAIL Scale assessment. The FRAIL Scale assessment is a validated 5-item scale comprising components from the Cardiovascular Health Frailty Index and Rockwood Scale.The five components measured include fatigue, resistance, ambulation, illness and loss of weight. The scale was dichotomized into two frailty categories based on prior literature on pain and frailty.16 Patients were classified as frail if they scored 3 or more on the 5-point scale and not frail if they scored below 3 .
Time frame: Up to 3 months 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).
Time frame: Up to 3 months postoperation
The duration when patients stay in hospital after surgery.
Chinese PLA General Hospital
Other
Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders: Retrospective Analysis of A Multi-Center Prospective Database in China
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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