Evaluation of Chronic Postsurgical Pain Risk in Patients Undergoing CIED Implantation Using an AID Support System
Not yet recruitingNCT07322900
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 preven…
Study details
- Official title
- 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
- Conditions
- Pain Measurement
- Chronic Pain
- Cardiac Implantable Electrical Devices
- Neuropathic Pain
- Chronic Post Surgical Pain
- Sponsor
- Istanbul University - Cerrahpasa
- Start date
- 2026-09-30
- Primary completion
- 2026-12-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07322900