Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing Cardiac Implantable Electronic Device (CIED) Implantation Using an Artificial Intelligence-Based Clinical Decision (AID) Support System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments
研究概览
简要总结
Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques. Patients receiving cardiac implantable electronic devices (CIEDs)-including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs)-constitute a unique population with high rates of multimorbidity, psychological vulnerability, and limited analgesic options due to cardiovascular comorbidities. Insufficient postoperative pain management in this group may lead to persistent pain at the generator site, neuropathic pain features, reduced quality of life, and increased healthcare utilization.
The present study aims to evaluate the prevalence, risk factors, and clinical predictors of CPSP following CIED implantation using both subjective and objective pain assessments. Pain intensity will be measured using validated self-report scales (Visual Analog Scale and DN-4 questionnaire), and objective pain thresholds will be determined using a calibrated digital pressure algometer. Quality of life will be assessed with the validated Turkish version of the Short Form-12 (SF-12) instrument.
This prospective observational study will include 180 adult patients who underwent first-time CIED implantation at Istanbul University-Cerrahpaşa, Cardiology Institute. Participants will be evaluated at 3, 6, and 12 months post-implantation. Collected data will include preoperative, intraoperative, and postoperative variables such as demographics, comorbidities, anesthesia type, surgical duration, and acute postoperative pain control.
Using the obtained data, an artificial intelligence-based clinical decision support system will be developed to predict individual CPSP risk before implantation. The model will integrate subjective scales, objective algometric data, and clinical factors to generate personalized risk estimates. Ultimately, this system aims to improve early detection and prevention of CPSP, optimize postoperative pain management strategies, and enhance patient quality of life.
详细描述
This prospective, single-center observational study will investigate chronic postsurgical pain after cardiac implantable electronic device (CIED) implantation and develop an artificial intelligence (AI)-based risk prediction model. The study will be conducted at the Istanbul University-Cerrahpaşa Cardiology Institute, Electrophysiology Outpatient Clinic, and will include 180 consecutive patients who received their first CIED within the past 12 months.
Study Design and Population Eligible participants are adults (≥ 18 years) undergoing first-time CIED implantation (pacemaker, ICD, or CRT device). Exclusion criteria include preexisting neuropathic disorders, neurodegenerative or autoimmune diseases, malignancy, trauma, infection, or previous generator replacement. All participants will provide written informed consent.
Data Collection and Measurements Patients will be evaluated at 3, 6, and 12 months post-implantation. Subjective pain assessment: Visual Analog Scale (VAS) and DN-4 questionnaire (neuropathic pain screening).
Objective pain threshold: Pressure Pain Threshold (PPT) measured with a digital pressure algometer on both the implantation and contralateral sides.
Quality of life: SF-12 (Physical and Mental Component Scores). Risk factors: Demographic, preoperative, intraoperative, and postoperative variables (age, sex, BMI, comorbidities, anesthesia type, surgical time, device type, lead number, battery position, acute postoperative pain, rehabilitation, analgesic use).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Patients who have undergone first-time implantation of a cardiac implantable electronic device (CIED), including pacemaker (PM), implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy device (CRT).
- •Device implantation performed within the past 12 months at Istanbul University-Cerrahpaşa Cardiology Institute.
- •Ability to attend scheduled follow-up visits at 3, 6, and 12 months post-implantation.
- •Ability to understand study procedures and provide written informed consent.
排除标准
- •History of neuropathic or chronic pain syndromes prior to implantation (e.g., fibromyalgia, diabetic neuropathy).
- •Presence of neurodegenerative, autoimmune, or vascular disorders affecting peripheral or central pain pathways.
- •Known malignancy, active infection, or recent trauma in the chest or upper extremities.
- •Prior CIED replacement or battery exchange procedures.
- •Use of chronic analgesic or neuropathic pain medications (e.g., opioids, gabapentinoids, antidepressants) for conditions unrelated to the procedure.
- •Cognitive impairment or psychiatric disorders that may interfere with study participation or reliable pain assessment.
- •Inability to comply with follow-up or withdrawal of consent at any time.
研究组 & 干预措施
CIED-Implanted Patients
This cohort includes adult patients who have undergone first-time implantation of a cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device) within the past year. Participants are prospectively followed at 3, 6, and 12 months after device implantation. Pain intensity is assessed using the Visual Analog Scale (VAS) and the DN-4 questionnaire, while objective pain sensitivity is measured using a digital pressure algometer. Quality of life is evaluated with the SF-12 form. Based on the one-year follow-up findings, patients will be categorized according to the presence or absence of chronic postsurgical pain (CPSP) to identify predictive risk factors and to develop an artificial intelligence-based clinical decision support model for early pain risk prediction.
结局指标
主要结局
Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments
时间窗: Assessed at 3, 6, and 12 months after CIED implantation; primary analysis at 12 months
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT). VAS\> 4 means positive result.
Incidence of Chronic Postsurgical Pain (CPSP) Based on DN-4 Assessments
时间窗: Assessed at 3, 6, and 12 months after CIED implantation; primary analysis at 12 months
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT). DN4 ≥ 4 means positive result.
Incidence of Chronic Postsurgical Pain (CPSP) Based on Pressure Pain Threshold Assessments
时间窗: Assessed at 3, 6, and 12 months after CIED implantation; primary analysis at 12 months
CPSP is defined as persistent or newly occurring pain at or near the device pocket (or corresponding dermatomes) lasting ≥3 months after surgery and not explained by other causes. Pain intensity and neuropathic features will be measured using the Visual Analog Scale (VAS) and DN-4; Pressure Pain Threshold (PPT) by digital algometry provides objective corroboration. The primary outcome is the proportion of patients meeting CPSP criteria at 12 months, with intermediate assessments at 3 and 6 months used for longitudinal description and sensitivity analyses. Type of Measure: Clinical assessment (subjective scales + objective PPT).There is no known cut-off value for the pain threshold in this patient group. One of the aims of this study is to determine a threshold value for chronic pain in this patient population using algometry, in correlation with clinical examination findings. We will evaluate the association between lower values and increased pain sensitivity in patients.
次要结局
- Change in Health-Related Quality of Life (SF-12 PCS/MCS)(3, 6, and 12 months post-implantation)
- Determination of Pressure Pain Threshold (PPT) Cut-off for CPSP(Up to 12 months (end of follow-up))
- Performance of the AI-Based CPSP Risk Prediction Model(After 12-month data lock (model training/validation phase))
- Prevalence of Neuropathic Pain Features (DN-4)(3, 6, and 12 months)
- Association of Risk Factors with CPSP (Multivariable Analysis)(12 months)
研究者
Gozde Altun
Assistant Professor
Istanbul University - Cerrahpasa