Effect of Intraoperative Dexmedetomidine on Postoperative Pain in Elderly Patients Undergoing Major Abdominal Surgery: a Secondary Analysis Based on Prospective Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,754
- 试验地点
- 1
- 主要终点
- The incidence of postoperative pain severity three months after the operation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years;
- •Underwent elective gastrointestinal and hepatobiliary surgeries.
排除标准
- •Patients with ASA grade IV or above;
- •Patients with missing exposure factor data;
- •Patients without postoperative pain assessment data;
- •Patients transferred to the ICU after surgery or who died within 7 days after surgery.
结局指标
主要结局
The incidence of postoperative pain severity three months after the operation
时间窗: 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).
次要结局
- The incidence of postoperative pain interference three months after the operation(Three months after the operation)
- Pain severity score(Three months after the operation)
- Pain interference score(Three months after the operation)
- EQ-5D-5L(At 7 days, 1 month and 3 months after the surgery)
- EQ VAS(At 7 days, 1 month and 3 months after the surgery)
研究者
Weidong Mi
Director of Department of Anesthesiology, The First Medical Center of Chinese PLA General Hospital
Chinese PLA General Hospital