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临床试验/NCT07564180
NCT07564180尚未招募4 期

Effect of Spinal Anesthesia With Bupivacaine Versus Prilocaine on Postoperative Shivering After Inguinal Hernia Repair : a Prospective Randomized Double Blind Study

Amr mohamed0 个研究点目标入组 80 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
主要终点
shivering using bedside shivering assesement score ( BSAS)

研究概览

简要总结

Effect of spinal anesthesia with bupivacaine versus prilocaine on postoperative shivering after inguinal hernia repair : a prospective randomized double blind study

详细描述

Inguinal hernia is the most common type of abdominal hernia, more common in men than women. Inguinal hernia repair is performed under general, spinal anesthesia or local anesthesia.

Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defenses in humans are sweating, arteriovenous shunt vasoconstriction, and shivering.

Spinal anesthesia is considered a safe anesthetic technique for the surgery, however 40 to 60 percent of patients' experience shivering due to vasodilatation, which facilitates rapid heat loss and causes a redistribution of body heat from the core to peripheral tissue. However, perioperative heat loss due to exposure of skin, evaporation from exposed sites, cold intravenous fluids, contribute to factors that predispose shivering. Postoperative shivering can be either thermos-genic with hypothermia or nonthermogenic associated with pain modulation and surgical stress.

Shivering is considered undesirable, as these random spontaneous, asynchronous skeletal muscle contractions increases the basal metabolism with increase in oxygen consumption up to be 600% hypoxemia, metabolic acidosis, triggering myocardial ischemia, increased wound pain, delayed wound healing, as well as increase in blood pressure, intraocular and intracranial pressure.

Bupivacaine is a long acting local anesthetic belonging to the amide group it is more stable and less likely to cause allergic reactions among other local anesthetics however; it delays hospital discharge in ambulatory surgery. Prilocaine is a local anesthetic belonging to the amide group with rapid onset, intermediate potency, and action.

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
Double (Participant, Care Provider)

盲法说明

The patient and the observers collecting data will be blinded to the patient's study group allocation.

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients with inguinal hernia under spinal anesthesia aged from 20 to 60 years

排除标准

  • Patients suffering from neurological diseases, uncompensated cardiac or respiratory problems, active lumber disc herniation, and history of addiction to other substances as well as those under treatment affecting results will be excluded from the study. Also, patients with a history of previous back surgery, infection at the injection site, hypersensitivity to amide local anesthetics, mental disturbance, congenital or acquired methemoglobinemia, coagulation disorders will also be excluded from the study.

研究组 & 干预措施

Prilocaine group

Active Comparator

Prilocaine intrathecal injection ( spinal anesthesia )

干预措施: Prilocaine spinal anesthesia (Drug)

Prilocaine group

Active Comparator

Prilocaine intrathecal injection ( spinal anesthesia )

干预措施: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine) (Drug)

Buivacaine group

Active Comparator

Bupivacaine intrathecal injection ( spinal anesthesia )

干预措施: Bupivacaine Spinal Anesthesia (Drug)

Buivacaine group

Active Comparator

Bupivacaine intrathecal injection ( spinal anesthesia )

干预措施: Spinal Anesthesia (bupivacaine) spinal anesthsia (prilocaine) (Drug)

结局指标

主要结局

shivering using bedside shivering assesement score ( BSAS)

时间窗: one year

shivering using bedside shivering assesement score ( BSAS)

时间窗: 1 year

shivering using bedside shivering assesement score ( BSAS)

次要结局

未报告次要终点

研究者

发起方
Amr mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amr mohamed

Dr.

Theodor Bilharz Research Institute

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