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临床试验/NCT07257744
NCT07257744招募中不适用

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

Karadeniz Technical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Chronic Postoperative Pain at 3 Months

研究概览

简要总结

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.

详细描述

This prospective observational study is designed to evaluate and compare three commonly used postoperative analgesia modalities in adult patients undergoing open heart surgery through median sternotomy: intravenous analgesia, thoracic epidural analgesia (TEA), and bilateral erector spinae plane block (ESPB). All analgesia techniques included in this study represent routine clinical practices performed by the anesthesia team, and no intervention is assigned according to a research protocol. Patients receive whichever analgesia method is chosen by the clinical anesthesia team based on individual clinical conditions. Thus, the study reflects real-world practice in a single tertiary cardiac surgery center.

The primary objective is to determine the effect of these analgesia methods on the development of chronic postoperative pain at 3 months following surgery. Chronic pain will be assessed using the Numeric Rating Scale (NRS) and the S-LANSS questionnaire, administered either via telephone or in-person follow-up. Secondary objectives include the evaluation of postoperative acute pain scores, additional analgesic consumption, extubation time, mobilization time, intensive care unit (ICU) length of stay, hospital length of stay, respiratory parameters, complications such as reintubation or need for non-invasive mechanical ventilation, bronchodilator use, sedation requirements, urine output, and perioperative hemodynamic stability. The study also aims to analyze the correlation between acute postoperative pain and subsequent chronic pain development.

Eligible patients are those aged 18-85 years, classified as ASA I-III, with a body mass index (BMI) below 35 kg/m², and scheduled for open heart surgery at Karadeniz Technical University Farabi Hospital. Exclusion criteria include coagulation disorders, infection at the intervention site, psychiatric disorders, chronic pain treatment, allergy to anesthetic agents, inability to cooperate or communicate, prior open heart surgery, chronic analgesic or antidepressant use, and significant comorbid conditions affecting participation.

Patients included in the study will have their perioperative data extracted from anesthesia records, ICU follow-up forms, and hospital medical charts. Routine postoperative pain measurements will be performed using the NRS. No additional procedures, medications, or interventions beyond routine care will be conducted.

The study aims to enroll 90 patients (30 per group). Data will be analyzed using Statistical Package for the Social Sciences (SPSS). Normality will be assessed using the Kolmogorov-Smirnov test. Parametric and nonparametric tests, including Student's t-test, Mann-Whitney U, chi-square test, repeated-measures ANOVA, and Friedman test, will be used as appropriate. A significance level of p < 0.05 will be accepted.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

结局指标

主要结局

Chronic Postoperative Pain at 3 Months

时间窗: 3 Months Postoperative

Chronic postoperative pain will be assessed 3 months after surgery using the Numeric Rating Scale (NRS, 0-10) and the S-LANSS questionnaire. Participants will be contacted via telephone or in-person follow-up. Chronic pain is defined as pain persisting beyond the expected healing period and lasting at least 3 months.

次要结局

  • Acute Postoperative Pain Scores(0-72 hours postoperative)
  • Additional Analgesic Consumption(0-72 hours postoperative)
  • Extubation Time(Up to 72 hours postoperative)
  • Mobilization Time(Postoperative day 0-2)
  • ICU Length of Stay(Up to 7 days)
  • Hospital Length of Stay(Up to 14 days)
  • Postoperative Respiratory Events(Up to 14 days postoperative)
  • Correlation Between Acute and Chronic Pain(From immediate postoperative period to 3-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali AKDOĞAN

Associate Professor of Anesthesiology and Reanimation

Karadeniz Technical University

研究点 (1)

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