An observational study in Chronic Postoperative Pain, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Chinese PLA General Hospital · Observational
This study is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective major abdominal surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. This study aims to evaluate the impact of intraoperative dexmedetomidine on chronic postoperative pain in elderly patients undergoing major abdominal surgery, with a comprehensive analysis of pain across multiple dimensions.
This study is a secondary analysis of multicenter prospective data, including elderly patients who underwent elective major abdominal surgery between April 2020 and April 2022 from a perioperative database of elderly patients in China. In this study, we specifically extracted and analyzed the data at the 3-month follow-up time point after abdominal major surgeries in elderly patients to evaluate the association between the intraoperative use of dexmedetomidine and postoperative chronic pain (CPSP) in this elderly patient population.
Exposure definition: Patients who received dexmedetomidine (dose range 0.2-1.0 μg/kg·h) for anesthesia induction or maintenance during the operation were defined as exposed, while those who did not receive it were the unexposed group.
Primary outcome: The primary outcome was the incidence of postoperative pain at 3 months, assessed using the Brief Pain Inventory (BPI).
Secondary outcomes: Secondary outcomes included pain severity, pain interference score, and health-related quality of life at 7 days, 1 month, and 3 months after surgery. Pain indicators were evaluated using the Brief Pain Inventory (BPI), and health-related quality of life was assessed using the EQ-5D-5L scale.
Statistical analysis: Missing covariates were handled using multiple imputation (m = 25), and potential confounders were controlled using inverse probability weighting (IPTW). Considering hospital clustering, all regression models had hospital as a random effect. A weighted logistic regression model was used to assess the impact of dexmedetomidine on the incidence of pain, a log-linear model was used to analyze pain severity scores and pain interference scores, and a linear mixed-effects model was used to analyze changes in health-related quality of life at the three time points after surgery.
Sample size and statistical power: Sample size estimation was based on previous literature. A prospective cohort study of patients undergoing gastrointestinal surgery showed that the incidence of chronic pain 3 months after surgery was 30.58% . Based on the results of a meta-analysis , the incidence of chronic pain 3 months after surgery in patients using dexmedetomidine was estimated to be reduced to 15.6%. Based on the distribution of patients meeting the inclusion and exclusion criteria in the database, the sample size ratio between the treatment group and the non-treatment group was approximately 1:2. Using PASS 2021 software, continuity correction was set, and under the two-sided test level α = 0.05 and test power 1 - β = 0.80, 251 patients (84 in the treatment group and 167 in the non-treatment group) were required. Considering a 20% dropout rate, the total sample size should be at least 314 cases (105 in the treatment group and 209 in the non-treatment group).
Data processing and quality control: All data will be extracted by trained researchers from the database.
Ethical considerations: Since this study only conducts a secondary analysis of anonymized existing data, the ethics committee waived the requirement for obtaining additional written informed consent from the participants. This study will be conducted in accordance with the Helsinki Declaration and relevant local regulations.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 2,754 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.
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This study is a secondary analysis based on a multi-center prospective database. We included 2,754 elderly patients who underwent major abdominal surgeries at five medical centers from April 2020 to April 2022. The data were sourced from Perioperative Database of Elderly Patients in China, which is a multi-center prospective study. The main objective of this parent study is to identify the perioperative risk factors for elderly non-cardiac surgery patients and establish a targeted risk prevention and management plan.
Exclusion Criteria:
The incidence of postoperative pain severity three months after the operation
The incidence of postoperative pain severity three months after the operation using the Brief Pain Inventory (BPI). The BPI assesses pain at its "worst," "least," "average," and "now" (current pain). The scores of these four items are summed up and averaged. Then, this average value is multiplied by 10 to convert it into a standard score ranging from 0 to 100. The incidence of chronic postoperative pain is defined as a score of ≥ 10 after conversion (that is, the original average score is ≥ 1).
Time frame: Three months after the operation
The incidence of postoperative pain interference three months after the operation
The incidence of postoperative pain interference three months after the operation using the Brief Pain Inventory (BPI). The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The pain scores of these seven items were summed up, and the average value was calculated. Then, this average value was multiplied by 10 to convert it into a standard score ranging from 0 to 100. The incidence of postoperative pain interference was defined as a converted score of ≥ 10 (that is, the original average score ≥ 1).
Time frame: Three months after the operation
Pain severity score
Pain severity score: the BPI assesses pain at its "worst," "least," "average," and "now" (current pain). The scores of these four items are summed up and averaged. Then, this average value is multiplied by 10 to convert it into a standard score ranging from 0 to 100.
Time frame: Three months after the operation
Pain interference score
Pain interference score: the BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The pain scores of these seven items were summed up, and the average value was calculated. Then, this average value was multiplied by 10 to convert it into a standard score ranging from 0 to 100.
Time frame: Three months after the operation
EQ-5D-5L
At 7 days, 1 month and 3 months after the surgery, the European Five-Dimensional Health Scale (EQ-5D-5L) were used to assess the dynamic changes in postoperative health-related quality of life. It includes five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression (the utility values converted according to Chinese standards quantify the health status of patients). The health status effect value range of EQ-5D-5L is from -0.391 to 1. A score lower than 0 indicates "worse than death", 0 indicates "no quality of life" or "death", and 1 indicates complete health.
Time frame: At 7 days, 1 month and 3 months after the surgery
EQ VAS
The overall health visual analogue score (EQ VAS) of the European Five-Dimensional Health Scale (EQ-5D-5L) was used to quantify the health status of the patients. The EQ VAS score ranges from 0 to 100, with a higher score indicating better function.
Time frame: At 7 days, 1 month and 3 months after the surgery
Plan to share: 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
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Chinese PLA General Hospital