Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders

Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders: Retrospective Analysis of A Multi-Center Prospective Database in China

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.

Study Overview

• Status: Completed
• Conditions: Chronic Postsurgical Pain
• Intervention / Treatment: Other: • no intervention

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 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.

• Study Type: Observational
• Enrollment (Actual): 7770

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital based group

Description

Inclusion Criteria:

• Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.
• Geriatric surgical patients ≥65 years old

Exclusion Criteria:

• Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
training group; elderly patients (aged ≥ 65 years) elderly patients undergo surgeries	Other: • no intervention; • no intervention
external validation group; elderly patients (aged ≥ 65 years) elderly patients undergo surgeries	Other: • no intervention; • no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain trajectories after surgery (Numerical Rating Scale)	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).	Up to 3 months postoperation
The Brief Pain Inventory-short form	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.	Up to 3 months postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	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)	within 30 days prior to surgery
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-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'.	within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation
The Hospital Anxiety and Depression Scale	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.	within 30 days prior to surgery , Up to 3 months postoperation
FRAIL Scale	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 .	within 30 days prior to surgery ,Up to 3 months 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 3 months postoperation
Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	Up to 3 months postoperation

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University People's Hospital; Sun Yat-sen University; Fudan University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; China-Japan Friendship Hospital; The Affiliated Hospital Of Guizhou Medical University; First Affiliated Hospital of Guangxi Medical University
• Investigators: Study Chair: Mi Weidong, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Validation; elderly; risk factors; Prediction; Chronic Postsurgical Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PLAGH-CPSP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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