Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System

Sponsor
Istanbul University - Cerrahpasa
Study ID
NCT07322900
Status
Not Yet Recruiting

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Conditions

  • Cardiac Implantable Electrical Devices
  • Chronic Pain
  • Chronic Post Surgical Pain
  • Neuropathic Pain
  • Pain Measurement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 7, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments [ Time Frame: Assessed at 3, 6, and 12 months after CIED implantation; primary analysis at 12 months ]

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