NCT05865366

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

April 22, 2023

Last Update Submit

November 15, 2025

Conditions

Keywords

acute postoperative pain, pain trajectory, chronic pain, elderly patient

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • consumption of analgesic drugs

    Seven days after surgery

  • cumulative illness rating scale for geriatrics,CIR S-G

    day1 before surgery

  • The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index,FRAIL)

    day1 before surgery

  • The douleur neuropathique 4 questionnaire(DN4)

    day1 before surgery

  • Mini-cog

    day1 before surgery

  • +4 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 22, 2023

First Posted

May 18, 2023

Study Start

June 1, 2023

Primary Completion

December 25, 2023

Study Completion

June 26, 2024

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations