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Comparison of Different Local Anesthetic Dose in Suprascapular and Axillary Blocks in Shoulder Arthroscopies

2022年3月1日 更新者:Nur Canbolat、Istanbul University

Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries

The research is designed as a single-center, prospective, randomized double-blind study. The patients undergoing shoulder arthroscopy surgery in Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will be excluded. Ultrasonography (USG) guided combined suprascapular and axillary block will be performed routinely for postoperative analgesia. After the block is performed, general anesthesia will be applied. The patients will be divided into 4 groups. Three different doses of local anesthetic will be given to patients (30 cc vs 20 cc vs 10 cc). Local anesthetic dose will be the same for suprascapular and axillary blocks. The fourth group will be sham control. Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patient will be observed for postoperative nausea and vomiting, first time to mobilization, length of hospital stay, analgesic consumption and satisfaction of surgeon and patient.

研究概览

详细说明

The investigators research was designed as a single-center, prospective, randomized double-blind study.

After the approval of the Ethics Committee, the study will start and is aimed to be completed in 6 months. The patients consecutively undergoing shoulder arthroscopy surgery in Istanbul University Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology will be included. Patients who are legally authorized to make decisions on their behalf will be informed about the research and their written consent will be obtained. Patients who do not give consent will not be included in the study.

Preoperative evaluation of the patients will include detailed history, demographic and clinical parameters including gender, age, indication for shoulder arthroscopy, creatinine, chronic disease history will be recorded. Patients will be taken to the operating room after premedication with 2 mg midazolam and 50 mg fentanyl.

Patients will be monitored for rhythm, blood oxygen and pressure in the operating room. Ultrasonography (USG) guided suprascapular and axillary block will be performed. Suprascapular and axillary block will be done for postoperative analgesia. After the block is done, general anesthesia will be applied. In this study there will be four groups with the control group included. For the first group 15cc+15cc , for the second group 10cc+10cc for the third group 5cc+5cc of local anesthetic will be injected. The fourth group will be sham control.

Pain score will be determined by visual pain scoring (VAS) and analgesic consumption will be provided by the use of a patient controlled analgesia (PCA) device with intravenous morphine applied in routine practice to all four groups at the postoperative 1, 4, 8,12 and 24 hours. Patients will be followed up for 48 hours postoperatively in routine practice. They will be observed for postoperative nausea and vomiting, first mobilisation time, lenght of hospital stay, analgesic consumption and surgent and patient satisfaction.

Before the study, it was determined that at least 132 patients should be collected in the power analysis performed with the help of similar literature data. After collecting the demographic data and morphine consumption data of the patients, statistical analysis will be performed with Statistical Package for the Social Sciences (SPSS). The investigators study does not contain any modifications other than the investigators daily routine practices.

研究类型

介入性

注册 (实际的)

132

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Fatih
      • Istanbul、Fatih、火鸡、34093
        • Istanbul University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients scheduled for total shoulder arthroscopy surgery
  • Patients with American Society of Anesthesiology (ASA) Class 1-3

Exclusion Criteria:

  • Refusal of regional anesthesia
  • Infection on the local anesthetic application area
  • Patients with known coagulopathy
  • Known allergy against local anesthetics
  • Anatomical difficulties to perform supra scapular and axillary blocks

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
其他名称:
  • 马卡因
有源比较器:Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
其他名称:
  • 马卡因
有源比较器:Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
其他名称:
  • 马卡因
有源比较器:Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
其他名称:
  • 血清生理学

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visual Analogue Scale (0-10) pain scores for patients
大体时间:48 hours
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
48 hours

次要结果测量

结果测量
措施说明
大体时间
Opioid (mg) consumption
大体时间:postoperative period up to 48th hours.
Opioid (mg) consumption
postoperative period up to 48th hours.

其他结果措施

结果测量
措施说明
大体时间
术后第一次活动时间
大体时间:长达 48 小时
首次动员时间
长达 48 小时
住院时间
大体时间:通过学习完成,平均1周
住院
通过学习完成,平均1周
患者满意度
大体时间:术后第 48 小时和术后第一个月
满意度评分; 0-非常不满意,3-非常满意
术后第 48 小时和术后第一个月
外科医生满意度
大体时间:术后第 48 小时和术后第一个月
满意度评分; 0-非常不满意,3-非常满意
术后第 48 小时和术后第一个月
Time of onset of narcotic analgesic need
大体时间:postoperative period up to 48th hours.
(If VAS > 4, morphine 0.05 mg/kg IV will be administered as rescue analgesia additional analgesia and maximum will be increased to 10 mg.
postoperative period up to 48th hours.
Incidence of side effects
大体时间:postoperative period up to 48th hour
Incidence of nausea and vomiting
postoperative period up to 48th hour

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Nil R Kirsan, MD、Istanbul University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年7月15日

初级完成 (实际的)

2022年2月21日

研究完成 (实际的)

2022年3月1日

研究注册日期

首次提交

2021年6月24日

首先提交符合 QC 标准的

2021年6月24日

首次发布 (实际的)

2021年7月1日

研究记录更新

最后更新发布 (实际的)

2022年3月2日

上次提交的符合 QC 标准的更新

2022年3月1日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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