Evaluating the Effectiveness of Cervical Erector Spinae Block for Shoulder Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (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
- •18 -65 years of agge
- •Undergoing elective shoulder surgery
排除标准
- •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)
结局指标
主要结局
Morphine consumption
时间窗: 24 hour postoperatively
All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.
次要结局
- Postoperative nausea and vomiting(24 hour)
- Numering Rating Scale scores for pain(24 hour)
研究者
Alper Kilicaslan
MD, Assoc.Professor
Konya Necmettin Erbakan Üniversitesi