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临床试验/NCT06307444
NCT06307444已完成不适用

Ultrasound-Guided Erectro Spinae Plane Block Versus Stellate Ganglion Block for Patients With Upper Limb Acute Herpes Zoster Pain: Randomized Controlled Study

Tanta University2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
reduction of a numeric rating scale (NRS) pain score

研究概览

简要总结

Herpes zoster (HZ) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

详细描述

Especially for elderly patients, when cell-mediated immunity wanes, common symptoms of HZ appear, primarily as pain in a dermatomal distribution with a burning, sharp pain sensation (paresthesia) and itching, in addition to development of a vesicular rash. The selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. The sympathetic fibers for the head, neck, heart, and upper limbs arise from the first thoracic segments, ascend through the sympathetic chain, and synapse in the superior, middle, and inferior cervical ganglions. The stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. It lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of C7. The erector spinae plane (ESP) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications

排除标准

  • We will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.

研究组 & 干预措施

medical treatment only

No Intervention

All patients will receive oral medication for antiviral therapy (800mg of acyclovir 5 times daily) at the time of diagnosis and supportive treatments, including acetaminophen (1gm 3times daily), and gabapentin (starting at 100mg three times daily) to be incrementally up titrated over time as needed by 100 to 300 mg every 3 to 5 days, to as high a dosage as 1800 to 3600 mg/day in 3 or 4 divided doses

Ultrasound-Guided Stellate Ganglion Block

Experimental

Ten milliliters of a local anesthetic solution (bupivacaine (0.25%)+ 8 mg dexamethasone) is injected until the fluid spreads along the paravertebral fascia to the stellate ganglion.

干预措施: Ultrasound-Guided Stellate Ganglion Block (Procedure)

Group III T2 T3 (High Thorathic) ErectroSpinae Plan Block

Experimental

ocal anesthetic drugs(0.2-0.3ml/kg of bupivacaine 0.25% 8mg Dexamethazone) will be administered as standard in all patients aiming to distribute within the plane between the anterior fascia of the erector spinae muscle and the transverse process.

干预措施: T2 T3 (High Thorathic) ESP Block (Procedure)

结局指标

主要结局

reduction of a numeric rating scale (NRS) pain score

时间窗: after the porcedure till 12 weak

1. Pain intensity before block by NRS score (0-10) 2. Pain intensity after block by NRS score (0-10) Pain intensity at 1,2,3,4, ,6,8,12 and24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aliaa Muhammad Belal

Principle investigator

Tanta University

研究点 (2)

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