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
Trial ID: NCT07322900
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-09-30
Completion date: 2027-03-01
Sponsor: Istanbul University - Cerrahpasa
Conditions: Pain Measurement; Chronic Pain; Cardiac Implantable Electrical Devices; Neuropathic Pain; Chronic Post Surgical Pain
Enrollment: 180
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Outcomes:
Incidence of Chronic Postsurgical Pain (CPSP) Based on Subjective VAS Assessments; Incidence of Chronic Postsurgical Pain (CPSP) Based on DN-4 Assessments; Incidence of Chronic Postsurgical Pain (CPSP) Based on Pressure Pain Threshold Assessments