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NCT Number: NCT05865366

Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients

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.

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Key information

Conditions

Acute Postoperative Pain Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Trajectory

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Acute pain trajectories after surgery

    Time frame: Seven days 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).

  2. Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.

    Time frame: 3 months after surgery

    Yes/No

  3. Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.

    Time frame: 6 months after surgery

    Yes/No

Secondary outcomes

  1. consumption of analgesic drugs

    Time frame: Seven days after surgery

    the amount of analgesic drugs will be recorded

  2. cumulative illness rating scale for geriatrics，CIR S-G

    Time frame: day1 before surgery

    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.

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

    Time frame: day1 before surgery

    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.

  4. The douleur neuropathique 4 questionnaire(DN4)

    Time frame: day1 before surgery

    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.

  5. Mini-cog

    Time frame: day1 before surgery

    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.

  6. The anxiety score assessed using Amsterdam preoperative anxiety and information scale

    Time frame: day1 before surgery

    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.

  7. Geriatrie depression scale，GDS-15

    Time frame: day1 before surgery

    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.

  8. Complications within 7 days after surgery

    Time frame: Seven days after surgery

    Complications will be recorded.

  9. Presence of pain before surgery assessed using the Brief Pain Inventory.

    Time frame: day1 before surgery

    Yes/No

Sponsors and collaborators

Lead sponsor

Feng Gao

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 18, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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