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Postoperative DepressionNCT07403838

The Impact of Preoperative Chronic Pain on Postoperative Depressive States in Elderly Patients Undergoing Joint Replacement Surgery: A Secondary Analysis Based on Prospective Data

An observational study of Postoperative Depression, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Postoperative depression is a significant complication that hinders recovery in elderly patients undergoing joint replacement surgery. Although preoperative chronic pain is common in this population and pain and depression frequently coexist, the predictive role and underlying mechanisms of preoperative… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Postoperative Depression
How many people
575 participants
Where
1 siteChina
Study dates
30 Apr 2022to 30 Apr 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
  • Healthy volunteers accepted
  • Older adult

Study population: This study is a secondary analysis based on a multicenter prospective database. We included 881 elderly patients who underwent elective joint replacement surgery at multiple medical centers between April 2020 and April 2022. The data were sourced from the Perioperative Database of Elderly Patients in China, which is a multicenter prospective study. The primary aim of this parent study was to identify perioperative risk factors in elderly patients undergoing non-cardiac surgery and to establish a targeted risk prevention and management system, utilizing data collected over a two-year period from 19 hospitals across the nation.

Who may be able to join

  • Age ≥ 65 years.
  • No cognitive impairment or history of mental illness.
  • Underwent elective joint replacement surgery.
  • Completed postoperative assessments, including questionnaires for depression, anxiety, and delirium.

Who cannot join

  • Non-general anesthesia.
  • Patients admitted to the intensive care unit postoperatively.
  • Medical centers with fewer than 50 cases. -

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Anesthesiology, First Medical Center of the People's Liberation Army General Hospital

    Beijing, Haidian, 100853

Other trials in China

About this study

Background:

Postoperative depression is a significant complication that hinders recovery in elderly patients undergoing joint replacement surgery. Although preoperative chronic pain is common in this population and pain and depression frequently coexist, the predictive role and underlying mechanisms of preoperative chronic pain on postoperative depression remain unclear. This study aims to systematically explore the association between the two, providing a basis for optimizing perioperative management and improving patient outcomes.

Read more

Methods:

This study is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective knee or hip replacement surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. The impact of preoperative chronic pain on the occurrence of depressive states within 7 days after surgery was systematically evaluated using univariate and multivariate logistic regression analysis, propensity score matching, and subgroup analysis.

Read the detailed description

Introduction Against the backdrop of the deepening global trend of population aging, the number of elderly individuals undergoing joint replacement surgery has increased significantly. Although this surgery effectively alleviates pain and restores joint function, perioperative mood disorders have become a key factor affecting patient recovery and long-term quality of life [1]. Among common orthopedic surgeries in the elderly, hip and knee replacements hold a prominent position. Since joint function directly impacts patients' basic living abilities such as walking and mobility, the risk of postoperative anxiety and depression is particularly pronounced. Studies indicate that the incidence of depression after joint replacement surgery can reach 33%, while the incidence of anxiety ranges between 25% and 33% [2,3]. Preoperative chronic pain is a prevalent clinical symptom in this patient population; however, whether an association exists between it and postoperative depression remains unclear due to a lack of systematic clinical evidence.

Notably, elderly patients undergoing joint replacement often have a long history of chronic pain, with studies showing a preoperative pain prevalence as high as 43.2% [4]. Known common risk factors for depression in the elderly include gender, age, sleep status, pain, and activities of daily living [5-7]. In the perioperative context, studies have confirmed that postoperative pain exacerbates mood disorders and increases the prevalence of depression [4]. However, compared to postoperative pain, preoperative chronic pain may exert multifaceted effects on postoperative outcomes, including mood and functional recovery [4,8]. Pre-existing chronic pain, as a potential and important predictor, has not been sufficiently explored for its unique impact on postoperative depression.

Based on this background, this study included 575 elderly patients undergoing joint replacement surgery to investigate the effect of preoperative chronic pain on postoperative depression in this population.

II. Research Objectives and Significance

Objectives:

To investigate the impact of preoperative chronic pain on postoperative depressive states in elderly patients undergoing joint replacement surgery, providing evidence to optimize perioperative management, reduce depression risk, and improve patient outcomes.

Significance:

Postoperative depression increases complications and adversely affects prognosis in elderly patients. By analyzing the impact of preoperative chronic pain on postoperative depressive states in elderly joint replacement patients, this study provides evidence to support interventions aimed at reducing postoperative depression. Addressing preoperative chronic pain may help prevent the occurrence of postoperative depressive states in elderly patients undergoing joint replacement surgery.

III. Research Content The correlation between preoperative chronic pain and postoperative depressive states in elderly patients undergoing joint replacement surgery. This study is a retrospective cohort study based on prospectively collected data. It extracts relevant data from the Perioperative Database of Elderly Patients in China for patients aged 65 and older who underwent joint replacement surgery between April 2020 and April 2022. Patients were divided into a no-chronic-pain group and a chronic-pain group based on the presence of preoperative chronic pain. Perioperative data were statistically analyzed to observe the occurrence of depressive states within one week postoperatively, as well as postoperative hospital stay length, postoperative acute pain, anxiety symptoms within one week, and the incidence of delirium.

IV. Study Design

  1. This study is a retrospective cohort study based on prospectively collected data. Sample Size:A post-hoc power analysis was performed using G*Power 3.1 software. Parameters were set as: significance level (α) two-tailed = 0.05, sample size (N) = 575. The results indicated that for correlation analysis (point-biserial correlation), this sample size is sufficient to achieve over 99% power (1-β) to detect an effect size (correlation coefficient r) as low as 0.1. This power far exceeds the commonly accepted standard of 80% in academia [9]. Therefore, the final inclusion of 575 patients in our study is adequate. Study Groups:Patients were divided into two groups based on the exposure factor (presence of preoperative chronic pain): Group 1: No chronic pain group; Group 2: Chronic pain group. Target Population:The data for this study were sourced from the Perioperative Database of Elderly Patients in China. This is a prospective observational cohort study conducted across multiple centers, which prospectively collected perioperative data from patients aged 65 and older undergoing elective non-cardiac, non-neurosurgical surgery at 19 tertiary hospitals between April 1, 2020, and April 30, 2022. This study is a secondary analysis of this database and will retrospectively extract the following existing data from eligible patients who underwent elective joint replacement surgery during the same period: (1) Baseline characteristics: age, gender, body mass index (BMI), American Society of Anesthesiologists physical status (ASA) classification, smoking, alcohol use, preoperative chronic pain history, comorbidities (hypertension, diabetes, coronary heart disease, cerebrovascular disease, hepatic insufficiency, renal insufficiency); (2) Preoperative laboratory tests (most recent before surgery): hemoglobin (Hb), white blood cell count, serum albumin; (4) Intraoperative variables: operation duration, bleeding and transfusion, intraoperative medications (dexmedetomidine, opioids, non-steroidal anti-inflammatory drugs, inhaled anesthetics), anesthesia method, and use of drainage tubes and analgesic pumps. Exposure Factor:The presence of preoperative chronic pain.
  2. Primary and Secondary Outcomes Primary Outcome: Occurrence of depressive states within 7 days postoperatively. Secondary Outcomes: Incidence of anxiety states within 7 days postoperatively; incidence of delirium within 7 days postoperatively; postoperative hospital stay length; incidence of postoperative acute pain. Postoperative Depressive State: Assessed at bedside within 7 days postoperatively by uniformly trained researchers using the Chinese version of the Patient Health Questionnaire-9 (PHQ-9). A PHQ-9 score >5 was defined as the occurrence of a depressive state [10]. Postoperative Anxiety State: Assessed at bedside within 7 days postoperatively by uniformly trained researchers using the Chinese version of the Generalized Anxiety Disorder-7 (GAD-7) scale. A GAD-7 score >5 was defined as the occurrence of an anxiety state [11]. Delirium:Assessed at bedside within 7 days postoperatively by uniformly trained researchers using the Chinese version of the 3D-CAM scale. Assessments were conducted twice daily, in the morning and afternoon. The Chinese version of the 3D-CAM scale is a widely adopted and validated assessment tool [12]. Postoperative Pain: Assessed using the Numerical Rating Scale (NRS). An NRS score ≥4 on the first postoperative day was defined as the occurrence of moderate-to-severe acute pain [13].
  3. Statistical Analysis Models were established based on the collected perioperative indicators. Univariate and multivariate logistic regression analyses, propensity score matching, and subgroup analyses were employed to explore the impact of preoperative chronic pain on postoperative depressive states.
  4. Participant Inclusion/Exclusion Criteria and Withdrawal/Discontinuation Criteria

Clinical data were retrospectively included for patients aged 65 years and older who underwent joint replacement surgery between April 2020 and April 2022 from the Perioperative Database of Elderly Patients in China.

Inclusion Criteria:

  1. Age ≥ 65 years.
  2. No cognitive impairment, defined as a preoperative Mini-Mental State Examination (MMSE) score below the education-adjusted cutoff: ≤17 points for illiterate individuals, ≤20 points for those with incomplete primary education, and ≤23 points for those with incomplete junior high school education.
  3. Underwent elective joint replacement surgery.
  4. Completed postoperative assessments, including questionnaires for depression, anxiety, and delirium.

Exclusion Criteria:

  1. Non-general anesthesia.
  2. Patients admitted to the intensive care unit postoperatively.
  3. Medical centers with fewer than 50 cases.

Data were collected strictly according to the inclusion and exclusion criteria.

VI. Management Plan for Common/Serious Adverse Reactions

This study is a retrospective cohort study and does not involve adverse reactions resulting from experimentation.

VII. Statistical Methods

Normally distributed continuous variables are expressed as mean ± standard deviation (SD) and compared using t-tests. If continuous data are not normally distributed, they are presented as median and interquartile range (IQR) and compared using the Mann-Whitney test. Categorical variables are expressed as frequencies or percentages and compared using the χ2 test or Fisher's exact test. Statistical significance was set at the 0.05 level, and all tests were two-tailed. Logistic regression models were performed using R version 4.0.1.

Keywords
Postoperative Depression Chronic Pain Elderly Patients Joint Replacement, Postoperative Depressive Symptoms, Postoperative Acute Pain, Preoperative Chronic Pain, Elderly
Medical subject headings
Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Severity Classification of Postoperative Depressive States (within 7 days)

    Postoperative depressive states were assessed using the Chinese version of the Patient Health Questionnaire-9 (PHQ-9). This scale was administered at bedside within 7 days after surgery by trained researchers. It is a self-reported tool comprising 9 items and is widely used for the efficient screening of clinical depressive symptoms. The assessment results were interpreted as follows: a total score ≥ 5 indicated the presence of a postoperative depressive state, with scores of 5-9 classified as mild, 10-14 as moderate, and 15-27 as moderately severe to severe.

    Measured: within 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2026
  2. Study start30 Apr 2022
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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
Retrospective
Enrolment
575 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07403838
Sponsor's protocol ID
PLAGH-PSD-001
Status last verified
Feb 2026
First submitted
1 Feb 2026
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) generated in this study are not planned to be shared publicly. The data contain sensitive personal health information and are subject to confidentiality protections under the ethical approval and data management regulations governing this research. Data access is restricted to the immediate research team for the purposes outlined in the approved study protocol

Publications

  • Li L, Wu P, Wang Z, Meng X, Zha C, Li Z, Qi T, Zhang Y, Han B, Li S, Jiang C, Zhao Z, Cai J. NoncoRNA: a database of experimentally supported non-coding RNAs and drug targets in cancer. J Hematol Oncol. 2020 Feb 28;13(1):15. doi: 10.1186/s13045-020-00849-7.

    PubMed 32111231
  • Ninova M, Ronshaugen M, Griffiths-Jones S. Conserved temporal patterns of microRNA expression in Drosophila support a developmental hourglass model. Genome Biol Evol. 2014 Aug 27;6(9):2459-67. doi: 10.1093/gbe/evu183.

    PubMed 25169982
  • Thomson KH, Rantala MH, Viita-Aho TK, Vainio OM, Kaartinen LA. Condition-based use of antimicrobials in cats in Finland: results from two surveys. J Feline Med Surg. 2009 Jun;11(6):462-6. doi: 10.1016/j.jfms.2008.10.005. Epub 2008 Dec 25.

    PubMed 19111491

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Depression, run by Chinese PLA General Hospital 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 3 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 11 Feb 2026. 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?

Incidence and Severity Classification of Postoperative Depressive States (within 7 days) (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07403838, which also lists 3 linked publications.

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 11 Feb 2026.

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