Utility of Early Serial Stellate Ganglion Block in Acute Herpes Zoster of Face and Neck
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 5
- 主要终点
- Incidence of Post-herpetic neuralgia
研究概览
简要总结
Patient who will be presented to Tanta University Hospitals complaining of acute herpes zoster with onset of vesicular eruption less than 7 days will be included in this clinical study.
Patients will be excluded if they refused participation, had allergy to local anesthetics, coagulopathy, local infection, glaucoma, or neurological deficit.
All the patients will receive acyclovir (antiviral therapy) and pregablin (analgesic) and the patients will be classified into two groups:- Group I (control group): Patients will receive sham block weekly for three times Group III (SGB group): Patients will receive stellate ganglion block weekly for three times
The time of first block after the onset of vesicular eruption, the incidence of PHN, NPRS at visit, duration of acute HZ , duration of PHN (if occurred), and the incidence of complication will be measured.
详细描述
This prospective randomized study will be carried out on adult patients complaining of acute herpes zoster presented at Tanta University Hospitals after approval from ethics committee for twelve months.
An informed consent will be taken from each patient. All data of patients will be confidential with secret codes and private file for each patient. All given data will be used for the current medical research only.
Any unexpected risk encountered during the course of the research will be cleared to the participant as well as to the Ethical Committee on time. Every patient will receive an explanation to the purpose of the study and will have a secret code number to ensure privacy of the participants and confidentiality of their data.
The study will be terminated in case of incidence of severe hypotension no responding to ephedrine (Mean arterial blood pressure less than 60 mmHg) or severe bradycardia not responding to atropine (Heart rate less than 40 b/min). The participants and the ethical committee will be announced.
There will be adequate supervision to maintain the privacy of patients and confidentiality of data. There will be no conflict of interest, nor conflict with religion, law, or society standards. The research will be beneficial to the society and has no risk of environmental pollution.
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)
盲法说明
- The patients will be blind through the use of closed sealed envelops.
- The investigator will be blind through the use of sham block in the control group.
- The measurement will be collected by anesthesiologist not participating in the study and blinded to its group
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who is presented to the pain clinic, diagnosed with acute herpes zoster of the face and/ or neck with onset of vesicular eruption less than seven days
排除标准
- •Patient refusal or un-cooperation
- •Known history of allergy to local anesthetics
- •Local infection at the site of the block
- •Platelet count less than 75,000/ cc
- •Neurological deficit in the upper limb
- •Bradycardia
结局指标
主要结局
Incidence of Post-herpetic neuralgia
时间窗: within 3 months of the last stellate ganglion block
The incidence of chronic neuropathic pain in the face or the neck after herpes zoster
次要结局
- The duration of herpes zoster(Through study completion, an average of 1 year)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University