Acute Postoperative PainNCT05865366
Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients
An observational study of Acute Postoperative Pain and Trajectory, run by Feng Gao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Postoperative Pain, Trajectory
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 26 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly patients scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, and major orthopedic surgeries under general anesthesia
Who may be able to join
- 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
Who cannot join
- Language disorder;
- Hearing impairment;
- Visual impairment;
- The expected postoperative intubation time is more than 24 hours;
- Critical events occurred during the perioperative period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Postoperative Pain, Trajectory
- Keywords
- acute postoperative pain, pain trajectory, chronic pain, elderly patient
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Seven days after surgery.
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
Yes/No
Measured: 3 months after surgery
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
Yes/No
Measured: 6 months after surgery
Secondary outcomes (9)
consumption of analgesic drugs
the amount of analgesic drugs will be recorded
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day1 before surgery
Complications within 7 days after surgery
Complications will be recorded.
Measured: Seven days after surgery
Presence of pain before surgery assessed using the Brief Pain Inventory.
Yes/No
Measured: day1 before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jun 2023
- Primary completion25 Dec 2023
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865366
- Sponsor's protocol ID
- TJ-IRB202303136
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients: a Prospective and Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05865366
- Acronym / sponsor ID
- TJ-IRB202303136
- Conditions
- Acute Postoperative Pain, Trajectory
- Keywords
- acute postoperative pain, pain trajectory, chronic pain, elderly patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patients scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, and major orthopedic surgeries under general anesthesia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Language disorder;
- Hearing impairment;
- Visual impairment;
- The expected postoperative intubation time is more than 24 hours;
- Critical events occurred during the perioperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.
Time frame: 3 months after surgery
Yes/No
Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.
Time frame: 6 months after surgery
Yes/No
9 secondary outcomes
consumption of analgesic drugs
Time frame: Seven days after surgery
cumulative illness rating scale for geriatrics，CIR S-G
Time frame: day1 before surgery
The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index，FRAIL)
Time frame: day1 before surgery
The douleur neuropathique 4 questionnaire(DN4)
Time frame: day1 before surgery
Mini-cog
Time frame: day1 before surgery
The anxiety score assessed using Amsterdam preoperative anxiety and information scale
Time frame: day1 before surgery
Geriatrie depression scale，GDS-15
Time frame: day1 before surgery
Complications within 7 days after surgery
Time frame: Seven days after surgery
Presence of pain before surgery assessed using the Brief Pain Inventory.
Time frame: day1 before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Postoperative Pain and Trajectory, run by Feng Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute pain trajectories after surgery (time frame: Seven days after surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.