RecruitingNCT07257744

Comparison of IV Analgesia, Thoracic Epidural Analgesia, and ESP Block for Chronic Pain After Open Heart Surgery

A Comparative Evaluation of Intravenous Analgesia, Thoracic Epidural Analgesia, and Erector Spinae Plane Block on Chronic Postoperative Pain Following Open Heart Surgery


Sponsor

Karadeniz Technical University

Enrollment

90 participants

Start Date

Feb 15, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This prospective observational study aims to compare three routinely used postoperative analgesia techniques in patients undergoing open heart surgery: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). The primary objective is to evaluate the impact of these analgesia modalities on the development of chronic postoperative pain at 3 months. Secondary objectives include assessing postoperative acute pain scores, additional analgesic requirements, extubation time, mobilization time, intensive care unit stay, hospital stay, respiratory complications, and the relationship between acute and chronic pain. No intervention is assigned by protocol, and all analgesia methods are applied as part of routine clinical practice.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

  • Adults aged 18 to 85 years
  • Classified as ASA physical status I-III
  • Scheduled to undergo open heart surgery with median sternotomy
  • BMI < 35 kg/m²
  • Able to understand and provide written informed consent
  • Eligible to receive any of the routine analgesia methods (intravenous analgesia, thoracic epidural analgesia, or erector spinae plane block)

Exclusion Criteria10

  • Age < 18 or > 85 years
  • BMI ≥ 35 kg/m²
  • Coagulation disorders
  • Infection at the intervention site
  • Known allergy to local anesthetics or induction agents
  • Psychiatric disorders limiting cooperation
  • Use of chronic pain medications, antidepressants, corticosteroids, antiepileptics, or routine analgesics
  • Inability to cooperate, communicate, or follow commands
  • Physical or verbal performance impairment
  • Previous open heart surgery

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Interventions

OTHERIntravenous Analgesia

Routine postoperative intravenous analgesia (opioid and/or non-opioid medications) administered according to standard clinical care. This is not assigned by protocol and represents usual practice.

OTHERThoracic Epidural Analgesia (TEA)

Thoracic epidural catheterization performed as part of routine postoperative analgesia management. This practice is determined by the clinical anesthesia team and not assigned by the study protocol.

OTHERErector Spinae Plane Block (ESPB)

Bilateral erector spinae plane block performed preoperatively as part of routine perioperative analgesia. The technique is applied at the discretion of the clinical anesthesia team and is not protocol-assigned.


Locations(1)

Karadeniz Technical University Farabi Hospital

Trabzon, Trabzon, Turkey (Türkiye)

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NCT07257744


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