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临床试验/NCT06507293
NCT06507293招募中不适用

Comparison of the Effects of Paravertebral Block and Erector Spinae Plane Block on Intraoperative Opioid Consumption Using NoL Index in Thoracotomy

Kocaeli University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Remifentanil consumption

研究概览

简要总结

Thoracotomy is among the most painful surgical procedures and can cause severe pain with a high incidence. Inadequate treatment of acute postoperative pain may lead to undesired complications. Paravertebral block (PVB) is an effective technique that provides adequate analgesia in thoracic surgeries. However, it is an advanced technique with potential complication risks. Erector spinae plane block (ESPB) is a relatively new and considered as a safer technique that provides comparable analgesia. However, the results are controversial and there are few studies that compares the effect of these blocks in thoracic surgeries. As well as the undesired effects of inadequate pain management, high doses of perioperative opioid usage may contribute to the development of dose-dependent long-term adverse events. Hemodynamic parameters are generally used to determine the intraoperative need for opioids in patients; however, hemodynamic parameters are not standardized and they do not provide a clear assessment. The Nociception Level (NoL) index is generated from five different parameters (heart rate, heart Rrate variability, photo-plethysmographic waveform amplitude, skin conductance level, number of skin conductance fluctuations, and their time derivatives) using a finger probe and is a promising monitoring technique. Selecting an effective analgesia method and determining the appropriate dose of opioids using NoL monitoring can reduce perioperative and postoperative complications and shorten hospital stays, allowing patients to return to daily life sooner. Additionally, preventing chronic pain syndromes that may develop in patients with inadequate analgesia, personalizing each patient's analgesia level, reducing healthcare costs, and improving quality of life can be achieved. The data from this study can demonstrate the analgesic efficacy of simpler regional anesthesia techniques, contributing to the widespread adoption of regional anesthesia applications, which is a crucial step in multimodal analgesia, thereby ensuring more effective pain management for surgical patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergo elective thoracotomy surgery
  • •ASA physical status I-III

排除标准

  • •Spinal deformities
  • •Patiens <50 kg
  • •Allergies to study medications

研究组 & 干预措施

ESP Group

Active Comparator

Patients who will receive erector spinae plane block

干预措施: Erector spiane plane block (Procedure)

PVB Group

Active Comparator

Patients who will receive paravertebral block

干预措施: Paravertebral block (Procedure)

结局指标

主要结局

Remifentanil consumption

时间窗: Intraoperative

Total amount of remifentanil used during the surgery (mg)

NRS Scores

时间窗: Postoperative 1st, 6th, 12th and 24th hours

Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)

Morphine consumption

时间窗: Postoperative 1st, 6th, 12th and 24th hours

Amount of morphine in the postoperative period (mg)

次要结局

  • Rescue analgesic(Postoperative 1st, 6th, 12th and 24th hours)
  • Nausea and vomiting(Postoperative 1st, 6th, 12th and 24th hours)

研究者

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

Hadi Ufuk Yörükoğlu

Principal investigator

Kocaeli University

研究点 (1)

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