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临床试验/NCT07034300
NCT07034300招募中4 期

Comparison of Lidocaine Alone Versus Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA)

Fatima Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月21日最近更新:
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Duration of Postoperative Analgesia

研究概览

简要总结

This study compares lidocaine alone vs. lidocaine with dexmedetomidine in Intravenous regional anesthesia (IVRA) for upper limb surgery in terms of pain scores and duration of analgesia

详细描述

Intravenous regional anesthesia effectively anesthetizes limbs for surgeries lasting under one hour. This method involves applying a pneumatic tourniquet and injecting a local anesthetic below the tourniquet to directly target major nerves. Intravenous regional anesthesia has certain limitations, including tourniquet-related pain, risk of local anesthetic systemic toxicity, limited postoperative pain relief, and the potential risk of compartment syndrome. Despite these concerns, it remains a reliable technique with reported success rates between ninety-four percent and ninety-eight percent.

This technique, originally introduced by August Bier, isolates the limb using pressure and a pneumatic tourniquet to retain the anesthetic effect in the target area. Lidocaine, a commonly used amide-type local anesthetic, was popularized for this method after successful use in 1963. However, lidocaine alone has limitations, such as incomplete sensory nerve block, discomfort from the tourniquet, and minimal pain control after the tourniquet is released. To improve these outcomes, additives have been combined with local anesthetics to enhance pain relief after the procedure and reduce intraoperative discomfort. However, the use of such additives has been limited due to concerns about side effects or uncertain effectiveness.

Alpha-2 adrenergic receptor agonists have recently gained attention for their sedative, pain-relieving, and cardiovascular-stabilizing effects in the perioperative setting. These agents can reduce the need for general anesthesia and prolong the effects of local anesthetics in regional anesthesia techniques. Clonidine, one such medication, when added to local anesthetics, has been associated with improved pain control in spinal, epidural, and peripheral nerve blocks compared to the use of local anesthetics alone. Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, offers a rapid onset of action and is recognized for its beneficial sedative and pain-relieving properties.

Dexmedetomidine has additional pharmacological effects, including lowering blood pressure, reducing anxiety, and providing sedation. These properties make it useful in clinical practice, especially in the management of surgical pain and in maintaining comfort for patients in critical care settings. It is often used both during surgical procedures and for sedation in intensive care units.

Studies comparing the use of lidocaine alone versus lidocaine combined with dexmedetomidine have shown that the combination significantly improves the duration of postoperative pain relief and reduces patient-reported pain levels. One study reported a longer duration of pain relief and lower pain scores in patients who received dexmedetomidine along with lidocaine. Another study found similar improvements in both the length of pain relief and pain intensity scores when the combination was used. Despite these promising results, there is a noticeable lack of research on this topic within Pakistan, largely due to the previous unavailability of dexmedetomidine in the local market. Therefore, this study was designed to compare the effectiveness of lidocaine alone versus lidocaine combined with dexmedetomidine in the setting of intravenous regional anesthesia.

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
None

入排标准

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

入选标准

  • American Society of Anesthesiology Status I
  • American Society of Anesthesiology Status II
  • Elective surgery
  • Surgery duration <45 minutes

排除标准

  • Sleep apnea
  • Heart block
  • uncontrolled hypertension

研究组 & 干预措施

Lidocaine

Active Comparator

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine

干预措施: Lidocaine (drug) (Drug)

Lidocaine with Dexmedetomidine

Experimental

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg)

干预措施: Lidocaine (drug) (Drug)

Lidocaine with Dexmedetomidine

Experimental

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg)

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Duration of Postoperative Analgesia

时间窗: Up to 24 hours post surgery

Time from surgery to first request for pain relief

次要结局

  • Pain Score according to Visual Analogue Scale (VAS)(2 hours post-operation)

研究者

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

Muhammad Mansoor Younas

Principal Investigator

Fatima Memorial Hospital

研究点 (1)

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