Comparison of the Efficacy of Different Local Anesthetic Dosage in Suprascapular and Axillary Blocks in Shoulder Arthroscopy Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (0-10) pain scores for patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for total shoulder arthroscopy surgery
- •Patients with American Society of Anesthesiology (ASA) Class 1-3
排除标准
- •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
研究组 & 干预措施
Group 1
In this group, US guided suprascapulary and axillary nerve block will be performed with 15cc+15c local anesthetic.
干预措施: Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection (Drug)
Group 2
In this group, US guided suprascapulary and axillary nerve block will be performed with 10cc+10c local anesthetic.
干预措施: Bupivacaine HCl 0.025 % in 10+10 ML Injection (Drug)
Group 3
In this group, US guided suprascapulary and axillary nerve block will be performed with 5cc+5c local anesthetic.
干预措施: Bupivacaine HCl 0.025 % in 5+5 ML Injection (Drug)
Group 4
In this group, US guided suprascapulary and axillary nerve block will be performed with serum physiologic.
干预措施: Isotonic solution (Drug)
结局指标
主要结局
Visual Analogue Scale (0-10) pain scores for patients
时间窗: 48 hours
The VAS (Visual Analog Scale, 0 ''no pain'', to 10, ''the worst pain possible'')
次要结局
- Opioid (mg) consumption(postoperative period up to 48th hours.)
研究者
Nur Canbolat
Principal Investigator, M.D.
Istanbul University