Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Erector Spina Plane Block in Open Gastrectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool
研究概览
简要总结
Open gastrectomy causes severe postoperative pain due to wide surgical incisions, retraction of the abdominal wall and direct manipulation of the visceral organs. It leads to delayed postoperative recovery, increased medical expenses and poor surgical outcomes. Epidural analgesia, intrathecal morphine and patient-controlled analgesia are frequently used in the postoperative pain management of abdominal surgeries. Intrathecal morphine is applied as a standard protocol in many centers due to its ease of application and effective pain control. However; it has undesirable effects such as postoperative nausea-vomiting, itching and most importantly respiratory depression. Regional interfascial plane blocks, such as erector spina plane block, have recently been popular in clinical practice to provide postoperative pain control. Erector spina plane block, when placed preoperatively, is expected to reduce opioid consumption and improve outcomes. The primary implication of this study is to compare postoperative pain scores and opioid consumption. It is also aimed to compare the effectiveness of Numeric Rating Scale and Clinically Aligned Pain Assessment Tool used in postoperative pain assesment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patients undergoing open gastrectomy surgery
排除标准
- •Patients with solid organ dysfunction
- •Patients who receive opioid or corticosteroid medication prior to surgery
- •Patients with bleeding diathesis
- •Patients with psychiatric disorders
- •Patients who can not be contacted after surgery
结局指标
主要结局
Postoperative pain assessment with Clinically Aligned Pain Assessment (CAPA) Tool
时间窗: 48 hours
CAPA tool functions as a conversation guide to gather categorical information during the course of a natural conversation. It focuses on how comfortable the patient is, whether discomfort is improving or worsening, whether the patient is able to participate in recovery activities and if pain is interfering with sleep.The clinician then codes and documents the conversation. Patient does not rate any scale or check boxes of responses.
Postoperative pain assessment with Numeric Rating Scale (NRS)
时间窗: 48 hours
In a Numerical Rating Scale (NRS), patients are asked to choose the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas ten represents 'the worst pain ever possible'
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device
时间窗: 48 hours
Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous morphine consumption will be recorded via PCA device, then it will be documented in mg/kg units.
次要结局
- Comparison of the frequency of treatment related complications(48 hours)
- Participant satisfaction(48 hours)
研究者
Beliz Bilgili
Associate Professor
Marmara University Pendik Training and Research Hospital