Cervical Erector Spinae Block for Shoulder Surgery
Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
Arthroscopic shoulder surgery is often associated with moderate to severe postoperative pain that may interfere with patients' early mobilization, recovery and quality of life.
In addition, by using an effective analgesic technique, a patient may experience less nausea, vomiting and drowsiness after surgery that are associated with the use of opioids to manage postoperative pain. Erector spinae plane block (ESPB) has been used in many different indications for acute pain treatment at different thoracic and lumbar levels. Recently, staining the roots of the brachial plexus has been reported in a cadaveric study of the cervical ESPB (1).
However, there are only few case reports related to efficiency and safety of this newly defined cervical ESPB technique (2) .
The primary objective of this randomized controlled is investigate the post-operative analgesic effectiveness of ultrasound guided single-shot cervical ESPB for patients undergoing arthroscopic shoulder surgery in comparison to those receiving conventional parentheral opioid analgesia alone.
Secondary objective is testing the safety of this newly defined block in terms of incidence of complications.
研究概览
地位
详细说明
60 patients will be enrolled to in this study between June 2020 - October 2020. All patient will be randomly selected who will be operated for shoulder surgery. Age, weight, ASA score, body mass index, additional dissease status will be recorded. The patients will be divided in two groups. One group will have cervical ESPB before the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia.
Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period, the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 3/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be applied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Konya、火鸡
- Necmettin Erbakan University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 -65 years of agge
- ASA I-II
- Undergoing elective shoulder surgery
Exclusion Criteria:
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
- obesity (body mass index >35 kg/m2)
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Block group
Cervical Erector Spinae Plane Block administered group
|
Cervical erector spinae plane block will be administered before the surgery
24 hour morphine consumption will be recorded
|
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假比较器：Control group
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24 hour morphine consumption will be recorded
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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 |
|---|---|---|
|
Morphine consumption
大体时间：24 hour postoperatively
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All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
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24 hour postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Numering Rating Scale scores for pain
大体时间：24 hour
|
Numeric Rating Scale (NRS) for pain will be used.
The Numeric Rating Scale (NRS-11) is an 11- point scale for patient self-reporting of pain.
It is for adults and children 10 years old or older.
0 means no pain and 10 means most imaginable pain
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24 hour
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Postoperative nausea and vomiting
大体时间：24 hour
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Incidence of postoperative nausea and vomiting will be recorded
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24 hour
|
合作者和调查者
调查人员
- 首席研究员：Alper Kilicaslan, MD, Assoc.Prof、Necmettin Erbakan University Meram Medical Faculty
- 首席研究员：İlker İnce, MD, Assoc.Prof、Ataturk University Medical Faculty
出版物和有用的链接
一般刊物
- Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
- Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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