Clinical trial NCT05372406: Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders
Official title: Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders: Retrospective Analysis of A Multi-Center Prospective Database in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Postsurgical Pain
Keywords: elderly
Chronic Postsurgical Pain
Prediction
risk factors
Validation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: First Affiliated Hospital of Guangxi Medical University
name: Sun Yat-sen University
name: The Affiliated Hospital Of Guizhou Medical University
name: Peking University People's Hospital
name: China-Japan Friendship Hospital
name: Fudan University
First posted: 2022-05-12
Enrollment: 7770
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based group

Brief 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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain trajectories after surgery (Numerical Rating Scale)
timeFrame: Up to 3 months postoperation
measure: The Brief Pain Inventory-short form
timeFrame: Up to 3 months postoperation
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: within 30 days prior to surgery
measure: The trajectories of health related quality of life(HRQoL)
timeFrame: within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation
measure: The Hospital Anxiety and Depression Scale
timeFrame: within 30 days prior to surgery , Up to 3 months postoperation
measure: FRAIL Scale
timeFrame: within 30 days prior to surgery ,Up to 3 months postoperation
measure: Complications within 30 days after surgery
timeFrame: Up to 3 months postoperation
measure: Postoperative duration of stay in hospital
timeFrame: Up to 3 months postoperation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Mi Weidong, PhD
role: STUDY_CHAIR
References: