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临床试验/NCT06540534
NCT06540534已完成不适用

Comparison of Anesthetic and Analgesic Efficacy of Dexamethasone as an Adjuvant in Selective Trunk Block

Gaziosmanpasa Research and Education Hospital2 个研究点 分布在 2 个国家目标入组 71 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
2
主要终点
onset times of motor and sensory blocks

研究概览

简要总结

"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks

详细描述

the investigators hypothesize that the perineural application of dexamethasone as an adjuvant in selective trunk block for upper extremity surgeries will accelerate the onset time of anesthesia and analgesia, provide significant anesthetic and analgesic effects, and prolong the duration of anesthesia and analgesia.

In recent years, the brachial plexus block, performed with various approaches, has been preferred over general anesthesia for upper extremity orthopedic surgeries due to its numerous advantages. It maintains the patient's consciousness and spontaneous respiration, reduces airway interventions, provides effective postoperative pain control, minimizes opioid-related side effects, limits surgery-related metabolic and endocrine changes, enables early discharge, and reduces treatment costs.

Selective trunk block offers rapid block onset and high success rates. The use of ultrasound in peripheral blocks has also reduced the risk of various complications (e.g., vascular injury). The selective trunk approach, as described by Manoj Kumar Karmakar in 2020, involves blocking the upper, middle, and lower trunks at the C7 transverse process level, resulting in sensory/motor block in all ipsilateral upper extremity dermatomes except T2. This study aims to compare the anesthetic and analgesic efficacy of dexamethasone as an adjuvant to bupivacaine in the selective trunk block approach.

Dexamethasone is a widely used glucocorticoid with anti-inflammatory, anti-toxic, and other effects. It has strong lipophilic properties, is soluble in fat, increases pH, facilitates the penetration of local anesthetics into nerve sheaths, and extends the duration of local anesthetic effects, as supported by various studies. Additionally, dexamethasone is commonly used in pain management for its neuromodulatory effects.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing upper extremity surgery with ASA (American Society of Anesthesiologists) classification I-II
  • aged 18-65 years, and with a body mass index (BMI) between 18-35 kg/m² were included in the study.
  • Exclusion criteria:
  • included ASA III-IV patients
  • those who refuse the block
  • pregnant and breastfeeding women
  • individuals with severe lung disease
  • contralateral diaphragm paralysis
  • nerve injury secondary to trauma
  • neuromuscular diseases,
  • peripheral neuropathy
  • bleeding diathesis
  • history of anticoagulant use
  • allergies to local anesthetics or dexamethasone
  • uncontrolled diabetes mellitus
  • morbid obesity with BMI >35 kg/m²
  • severe cardiovascular, renal, or liver disease, and infections at the site where the nerve block is to be applied.

排除标准

  • 未提供

结局指标

主要结局

onset times of motor and sensory blocks

时间窗: first 30 minutes after the block aplication

primary aim is to compare the effects of adding dexamethasone as an adjuvant to bupivacaine in selective trunk blocks on the onset times of motor and sensory blocks required for anesthesia.

次要结局

  • first postoperative rescue analgesia(within 24 hours after the surgery hours)
  • postoperative total motor block duration and analgesia duration.(within 24 hours after the surgery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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