Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients

Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients: a Prospective and Observational Cohort Study

This study will use group-based trajectory modeling to identify the different postoperative pain trajectory groups that exist in a mixed surgical population (non-cardiac surgery) of elderly patients during the first seven days after surgery. The aim of this study is to explore the diversity in the development of postoperative pain among elderly patients and to identify the risk factors for acute pain trajectory after surgery by investigating demographic, psychological, and clinical variables. The predictive effect of different trajectories of early postoperative acute pain on postoperative chronic pain will also be explored.

Study Overview

• Status: Completed
• Conditions: Acute Postoperative Pain; Trajectory

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

elderly patients scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, and major orthopedic surgeries under general anesthesia

Description

Inclusion Criteria:

1. Scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, or major orthopedic surgery under general anesthesia
2. Age ≥ 65 years
3. The American Society of Anaesthesiologists(ASA) I to III
4. Duration of hospitalization ≥ 72 hours

Exclusion Criteria:

1. Language disorder;
2. Hearing impairment;
3. Visual impairment;
4. The expected postoperative intubation time is more than 24 hours;
5. Critical events occurred during the perioperative period.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute pain trajectories after surgery	The acute pain trajectories are vectors of 7 numerical pain scores (ranging from 0 ,which indicates "no pain," to 10 , which indicates "pain as bad as you can imagine") taken over 7 days (days 1, 2, 3, 4, 5, 6, 7).	Seven days after surgery.
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.	Yes/No	3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.	Yes/No	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of analgesic drugs	the amount of analgesic drugs will be recorded	Seven days after surgery
cumulative illness rating scale for geriatrics，CIR S-G	The Cumulative Illness Rating Scale (CIRS) is utilized to assess comorbidities and comprises of 14 components, each with a severity score ranging from 0 to 4. A score of 0 indicates no damage, while a score of 1 denotes minor damage that does not impede normal activity and has a positive prognosis without treatment. A score of 2 indicates moderate damage, while a score of 3 denotes severe damage that may result in disability and necessitates immediate treatment with a poor prognosis. A score of 4 indicates fatal damage that requires urgent treatment and has a severe prognosis.	day1 before surgery
The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index，FRAIL)	The scale includes fatigue, resistance, ability to walk a block, concomitant illness, and weight loss. Frailty is defined by the presence of three or more of the criteria.	day1 before surgery
The douleur neuropathique 4 questionnaire(DN4)	This questionnaire serves as a diagnostic tool for identifying neuropathic pain. It comprises 10 options, consisting of 7 self-assessment items that evaluate symptoms. The total score is 10 points, and a score of ≥ 4 indicates the possibility of neuropathic pain, while a score < 4 rules out neuropathic pain.	day1 before surgery
Mini-cog	The Mini-Cog uses recall and clock-drawing tests to determine whether patients have cognitive impairments. A score of 0-2 indicates a positive dementia screening, while a score of 3-5 implies a negative screening, necessitating further evaluation.	day1 before surgery
The anxiety score assessed using Amsterdam preoperative anxiety and information scale	The Amsterdam preoperative anxiety and information scale is a tool utilized to assess the level of anxiety and the amount of information patients possess before undergoing surgery.The items can be categorized into three groups - anesthesia-related anxiety score (item 1+item 2), surgery-related anxiety score (item 3+item 4), and information needs score (item 5+item 6). The total anxiety score is the sum of the scores for anesthesia-related anxiety and surgery-related anxiety, with higher scores indicating greater levels of anxiety.	day1 before surgery
Geriatrie depression scale，GDS-15	This scale serves as a diagnostic tool to screen for depression in the elderly population. A rating of 0 to 5 is within the normal range, while a score of 5 or above is indicative of a possible depression. If the total score exceeds 10, it may be appropriate to refer the individual to a psychiatric specialist for further assessment and diagnosis.	day1 before surgery
Complications within 7 days after surgery	Complications will be recorded.	Seven days after surgery
Presence of pain before surgery assessed using the Brief Pain Inventory.	Yes/No	day1 before surgery

Collaborators and Investigators

• Sponsor: Feng Gao

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: April 22, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: acute postoperative pain, pain trajectory, chronic pain, elderly patient
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: TJ-IRB202303136

Drug and device information, study documents

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