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临床试验/NCT07519694
NCT07519694尚未招募不适用

Comparative Study Between Different Additives to Lidocaine 2٪ for Peribulbar Block in Vitreoretinal Surgery (Prospective Comparative Randomized Controlled Trial

Sohag University1 个研究点 分布在 1 个国家目标入组 90 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
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Onset of Akinesia

研究概览

简要总结

Peribulbar block, is the favored anesthetic technique for numerous ophthalmic procedures due to its lower rate of associated complications .

Retinal surgeries have many problems to the anesthesiologists as these operations are often lengthy , involve a significant risk of postoperative pain ,and typically involve an elderly patient population with multiple comorbidities .

Many anesthesiologists consider the peribulbar block as a safe technique; however, it has the disadvantage of a slow onset of orbital akinesia and to produce it a more substantial volume or repeated injections of local anesthetic solution is required due to limited diffusion of local anesthetics . This also increases the frequency of complications, such as globe perforation and peribulbar hemorrhage .

To prevent this and to increase tissue perfusion, hyaluronidase and other adjuvants such as clonidine, epinephrine and alkalinization of local anesthetics were used to improve peribulbar block.

Hyaluronidase may reduce tissue viscosity , which facilitate the complete diffusion of anesthetic solution along tissue planes .

in regional anesthesia is the addition of hyaluronidase is associated with benefits such as faster onest of action and impoved block quality ,however ,evidence regarding its efficacy in peribulbar techniques remains inconsistent.

To improve the quality and duration of the block, various adjuvants have been investigated. Two promising agents are Midazolam, a benzodiazepine with hypothesized peripheral GABA-ergic action, and Cisatracurium, a non-depolarizing neuromuscular blocking agent. Midazolam may enhance sensory block and provide amnesia, while cisatracurium directly induces chemical paralysis of the extraocular muscles. However, a direct comparative study of their efficacy and safety profiles in this context is lacking. This study aims to fill that gap .

90 eligible patients were randomly allocated into three groups using computer-generated random numbers placed in sealed, opaque envelopes.

  • Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml).
  • Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).
  • Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).

The total volume of the injectate was standardized to 5 ml for all groups.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-III patients -enrolled for elective vitreoretinal procedures under peribulbar block.

排除标准

  • Patient refusal
  • allergy to study drugs
  • coagulopathy
  • infection at the injection site
  • significant axial myopia (axial length >26mm)
  • neurological or neuromuscular disorders
  • pregnancy
  • inability to communicate.

研究组 & 干预措施

· Group L (Control): lidocaine 2٪ (4 ml) + Normal Saline (1 ml).

Placebo Comparator

· Group L (Control): peribulper lidocaine 2٪ (4 ml) + Normal Saline (1 ml).

干预措施: Group L (Control) (Drug)

Group M (Midazolam): lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).

Active Comparator

Group M (Midazolam):peribulber injection of lidocaine 2٪ % (4 ml) + Midazolam (1 mg in 1 ml).

干预措施: · Group M (Midazolam): (Drug)

· Group C (Cisatracurium): lidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (

Active Comparator

· Group C (Cisatracurium): peribulber injection oflidocaine 2٪ (4 ml) + Cisatracurium (0.5 mg in 0.5 ml) + Normal Saline (0.5 ml).

干预措施: · Group C (Cisatracurium): (Drug)

结局指标

主要结局

Onset of Akinesia

时间窗: investigator assess muscle tone immediately after start of anesthesia and every 15 minute up to end of surgery

onset of muscle paralysis (loss of muscle tone)

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

Waleed Adel Ahmed

lecturer of anaesthesia and intensive care

Sohag University

研究点 (1)

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