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临床试验/NCT01344252
NCT01344252撤回4 期

Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions

Hospital Italiano de Buenos Aires2 个研究点 分布在 1 个国家开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
number of subjects who prefer topical anesthesia.

研究概览

简要总结

The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.

Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.

Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.

Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • bilateral cataract

排除标准

  • refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis

研究组 & 干预措施

Topical

Experimental

干预措施: Lidocaine (Drug)

subtenon

Active Comparator

干预措施: Lidocaine (Drug)

结局指标

主要结局

number of subjects who prefer topical anesthesia.

时间窗: 1 month

The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)

次要结局

  • intraoperative pain(1 hour)

研究者

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

Tomás Ortíz Basso

Ophthalmologist

Hospital Italiano de Buenos Aires

研究点 (2)

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