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

NCT05372406 | Completed

• 1 other identifier: PLAGH-CPSP-001
• Study Type: observational
• Target: 7,770
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Postsurgical Pain

Keywords

elderly; Chronic Postsurgical Pain; Prediction; risk factors; Validation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pain Catastrophizing Scale

  within 30 days prior to surgery

• The trajectories of health related quality of life(HRQoL)

  within 30 days prior to surgery , 1, 3, 7, 30, 90 days postoperation

• The Hospital Anxiety and Depression Scale

  within 30 days prior to surgery , Up to 3 months postoperation

• FRAIL Scale

  within 30 days prior to surgery ,Up to 3 months postoperation

• Complications within 30 days after surgery

  Up to 3 months postoperation

Study Arms (2)

training group

elderly patients (aged ≥ 65 years) elderly patients undergo surgeries

Other: • no intervention

external validation group

elderly patients (aged ≥ 65 years) elderly patients undergo surgeries

Other: • no intervention

Interventions

• no intervention OTHER

• no intervention

external validation group; training group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hospital based group

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Sun Yat-sen University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Peking University People's Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mi Weidong, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of administration, Anesthesiology

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

CN (1)