Can Ultrasound-Guided Bilateral Cervical Plexus Block Combined With Translaryngeal Block For Tracheostomy Be An Alternative To General Anesthesia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- pain score (NRS)
研究概览
简要总结
Current healthcare delivery models emphasize enhanced postoperative recovery (ERAS) with minimal morbidity and shorter hospital stays. Most tracheostomy cases are tumour patients. The more the patients have difficulty in breathing, the more difficult it is to anaesthetize them. Adequate intraoperative anaesthesia and postoperative analgesia with minimal sedation play an essential role in this patient model. In tracheostomy patients, moving away from the general anaesthesia option increases airway safety, and avoiding the local anaesthesia option in the incision area increases patient comfort. The purpose of this study is to assess the safety and efficacy of regional anaesthesia in tracheostomy patients.
详细描述
after being informed and about the study and potential risks, all patients giving written informed consent will undergo 24 hours screening period to determine the eligilibity for study entry. After a computer-generated randomization list with a 1:1 intergroup ratio, ensuring equal distribution in the two groups, 30 opaque sealed envelopes numbered 1-30 were prepared. The patients were randomly divided into the Group with bilateral CPB with 15 ml 0.5% bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition to bilateral CPB.
CPB: cervical plexus block.
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
- Single (Participant)
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
- •Being in the age range of 18-65, with American Society of Anesthesiology (ASA) classification I-III and scheduled for elective or emergency tracheostomy.
- •A sufficient level of education to understand the study procedures and agree to participate in the study
排除标准
- •inability to cooperate
- •dementia,
- •allergy to local anesthetics and opioids
- •regular daily opioid requirements
- •abuse of alcohol or medication
- •local infection at the site of injection or systemic infection,
- •pregnancy.
结局指标
主要结局
pain score (NRS)
时间窗: 24 hours
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
pain related to incision
时间窗: 24 hours
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
nausea and vomiting
时间窗: 24 hours
YES/NO
time to first analgesic demand
时间窗: 24 hours from the pacu
Time of first analgesic need within the first 24 hours 0: within the first 12 hours 1: 12-24 hours
Patient tolerance as assessed by tracheostomy cannula comfort score
时间窗: 24 hours
1. = No reaction 2. = Slight grimacing 3. = Heavy grimacing 4. = Defensive movement of hands 5= Flexion of the head with defense
cough and gag score
时间窗: 24 hours
1. = None 2. = Slight 3. = Moderate 4. = Severe
次要结局
未报告次要终点
研究者
Ayhan ŞAHİN
Asistant Prof
Namik Kemal University