20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis: A Controlled Randomised Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- hyperhydrosis severity scale
研究概览
简要总结
Palmar hyperhidrosis is a medical condition characterized by excessive sweating specifically from the palms of the hands. This condition can significantly impact an individual's quality of life, leading to social embarrassment, anxiety, and difficulties in daily activities. It is classified as a type of primary hyperhidrosis, which means it occurs without an identifiable underlying medical cause.
The prevalence of palmar hyperhidrosis is estimated to affect about 1% to 3% of the population. Symptoms typically begin in childhood or adolescence, often becoming more pronounced during periods of hormonal changes such as puberty. The condition may run in families, suggesting a genetic predisposition.
The underlying mechanism involves hyperactivity of the sympathetic nervous system, particularly affecting the eccrine sweat glands located in the palms .
Unlike normal sweating, which primarily serves thermoregulation (cooling the body), palmar hyperhidrosis is triggered by emotional stimuli such as stress or anxiety rather than heat. This inappropriate activation leads to excessive sweating that can occur even at rest .
Diagnosis is primarily clinical and based on patient history and visible signs of excessive sweating. Patients often report episodes that are bilateral and symmetrical, with cold and wet palms that may appear pale or blushed. The diagnosis does not typically require extensive testing unless secondary causes are suspected.
Treatment for palmar hyperhidrosis can be challenging due to varying degrees of severity and individual responses to therapies.
Common treatment options include topical treatments as aluminum chloride hexahydrate which is considered one of the most effective topical treatments for palmar hyperhidrosis. It works by blocking sweat pores and reducing gland activity. Application involves using a concentrated solution on dry skin at night until symptoms improve, followed by maintenance therapy.
Another option of treatment is iontophoresis; this technique uses electrical currents to temporarily block sweat gland function. It requires multiple sessions but can be effective for many patients.
Botulinum toxin type A can be injected into affected areas to inhibit neurotransmitter release responsible for activating sweat glands. While effective, this treatment requires repeated injections every few months due to its temporary effects .
Anticholinergic drugs have been used but are often limited by side effects such as dry mouth and constipation at effective dosages .
Regarding surgical options; surgical sympathectomy is considered a last resort for severe cases where other treatments have failed. This procedure involves cutting nerves that trigger sweating but carries risks such as compensatory sweating in other body areas.
Finally, palmar hyperhidrosis is a common yet often underreported condition that can severely affect individuals' lives due to its social implications and discomfort associated with excessive sweating. Treatment options vary widely in effectiveness and side effects, necessitating a tailored approach based on individual needs.
详细描述
Study tools:
- After approval of study protocol, patients will be enrolled into the study according to inclusion and exclusion criteria.
- A total of 50 patients will be categorized into 2 groups:
- Group A "Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique
- Group B " Stellate Ganglion Block steroid local anesthetic technique only
- Patients will give their consent after having been fully informed about the more frequent side effects of each procedure, such as compensatory sweating and especially those after the block : interscapular pain, transient pneumothorax, and Horner's syndrome.
- Objective Sweating Assessment:
- Patients transferred from dermatology clinic after Diagnosis with primary hyperhidrosis and failed topical treatement.
- asses severity of sweating by HDSS.
- Stellate Ganglion Block 20% alcohol with steroid local anesthetic technique
- The patient will be placed in the supine position on the operating table.
- Routine monitoring: pulse oximetet, ABP&ECG
- IV canula
- patient will sedate befoer starring the procedure By "midathetic +fentanyl"
- support the patient with oxygen By nasal canula sterilized drape will be used to ensure safety. The needle tip will be placed in the stellate ganglion under ultrasound guidance "high frequency linear probe" EG LOGIQ L6-12-RS" Alcohol 20% 2ml, lidocaine" 2% 3ml, Dexamethasone amp 8mg 2ml and 3ml normal saline will be used for Stellate Ganglion Block. inject a total of 10 mL of the mixture.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 45 years.
- •Both genders.
- •Exhibiting primary palmar hyperhidrosis.
- •All patients with hyperhidrosis and were socially, professionally, and psychologically handicapped.
- •All patients with failed previous dermatological topical treatment as aluminum chloride hexahydrate
排除标准
- •An inability of patient to cooperate.
- •Known allergies to alcohol or local anaesthetic.
结局指标
主要结局
hyperhydrosis severity scale
时间窗: After 1 hour of injection
presence/absence of hyperhidrosis
次要结局
未报告次要终点
研究者
Atef Mohamed mahmoud
Associated Professor
Fayoum University Hospital
