The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
This study aims to investigate the effect of local nasal anesthesia with lidocaine spray on the insertion of nasal tampons during active nasal bleeding.
详细描述
Nasal packing has many uses, such as prevention of postoperative bleeding following endoscopic sinus surgery, stabilization of the nasal septum, prevention of adhesions following septoplasty, and treatment of active epistaxis1,2.
The utilization of tampons for nasal packing during nasal and sinus surgeries is widely used and safe. Nasal tampons assist in creating a moist supportive environment for tissue healing without causing local irritation or foreign body reaction3. The removal is performed after 24-48 hours. On the other hand, there are some disadvantages to the uses of nasal tampons: trauma to the nasal mucosa, infection of the nose and sinuses, aspiration of part of the tampon, and even toxic shock syndrome3. One of the most troublesome aspects to the patient and the clinician is the pain and discomfort during insertion and removal of the tampons3,4. In our experience, these symptoms are of considerable significance to the patient experience and satisfaction.
There is a wide range of commercially available nasal packings such as Merocel and Nasopore.
In our practice, Merocel nasal tampons are used, which contain polyvinyl acetate. This type of material expands upon contact with fluids, and it is not soluble. This product is used at the end of endoscopic nasal surgeries and in the treatment of active epistaxis, not amenable to local pressure and without a recognizable source of bleeding. In case of unstoppable bleeding despite the use of nasal tampons, a nasal balloon is inflated in the nasal cavity. Its insertion and inflation are associated with patient pain and discomfort.
Lidocaine is a drug commonly used for local anesthesia. It is used for local nasal anesthesia by a variety of commercially available sprays, atomizers, nebulizers, gels, and ointments. Lidocaine causes local anesthesia by affecting sodium channels, causing decreased initiation and conduction of neural impulses. In turn, fewer afferent impulses reach the central nervous system6. In healthy individuals, side effects are negligible, but it could influence patients with cardiac infarction. The main side effects of lidocaine are neurological, which could be of significance in the case of inflamed or damaged tissue because of rapid absorption. The use of Lidocaine spray (Xylocaine 10%) is commonly available worldwide and is routinely used in our institution before fiberoptic laryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both Xylocaine spray and Placebo (saline) will be in similar containers with serial numbers, Both clinician and patient are blinded to the content.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years or older
- •Both sexes
- •No known allergy for local anesthetics agents
- •Patients with active nasal bleeding requiring the insertion of a tampon or an inflatable balloon, or patients requiring tampon removal postoperatively.
排除标准
- •Age under 18 years.
- •Known allergy to local anesthetics
- •Lack of willingness to participate in a clinical trial
- •Patient unable to give informed consent from any reason
- •Pregnancy
研究组 & 干预措施
Xylocaine
30 patients who receive Xylocaine 10% nasal spray
干预措施: Xylocaine Mucosal Product (Drug)
Saline
30 patients who receive saline nasal spray
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Immediately after the procedure
Visual Analogue Scale (VAS) ranging from 0- no pain at all to 10 - unbearable pain.
次要结局
- Patient Questionnaires(Immediately after the procedure)
研究者
Muhamed Masalha
Dr, Muhamed Masalha; Principal Investigator; Senior Surgeon in the Endoscopic Sinus Surgery Unit, the Department of Otolaryngology-Head and neck surgery
HaEmek Medical Center, Israel
