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临床试验/NCT02263690
NCT02263690已完成4 期

Comparison of Three Different Anesthetic Approaches for Intravitreal Injections: A Prospective Randomized Trial

Retina Clinic, Sao Paulo, Brazil2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
92
试验地点
2
主要终点
Pain experience and patient satisfaction after 3 different anesthetic approaches for intravitreal injections

研究概览

简要总结

92 patients in treatment with intravitreal injections were randomized to 1 of 3 groups: proparacaine 0.5% drops (Group Drops), proparacaine 0.5% drops plus subconjunctival lidocaine (Group SC), or 2% lidocaine gel (Group Gel). Patients were asked to score their pain experience using a visual analogue scale (VAS), a scale of 0 to 10, immediately following the injections as well as 10 minutes, 1 hour, 6 hours and 24 hours after. Patients also graded the overall injection experience as Excellent, Very Good, Fair, Poor or Awful. The physician evaluated the patient's eye movement during intravitreal injection in three levels: none or minimal (0), not compromising the injection (1), compromising the injection (2).

详细描述

This prospective, randomized, triple-armed trial compared the effectiveness of three different anesthetic approaches for intravitreal injections. Were included 92 consecutive patients scheduled to receive intravitreal injection of bevacizumab (Avastin, Genentech, Inc.) in one eye, from June 2014 to September 2014, evaluated at at a single center - Retina Clinic, Osasco, São Paulo, Brazil. The same ophthalmologist (CGA) administered both, anesthetic and therapeutic, injections. A masked nurse collected patient assessment responses and a masked statistician performed statistical analyses. The research followed the tenets of the Declaration of Helsinki and was approved by the Committee of Ethics in Research. All participants gave written informed consent prior to their participation.

Patients were randomized to 1 of 3 groups before injection: proparacaine 0.5% drops (Anestalcon®, Alcon Lab. do Brasil Ltda, São Paulo, Brazil), (Group Drops), proparacaine plus subconjunctival lidocaine 1% (Xylestesin®, Cristália, São Paulo, Brazil) (Group SC), or 2% lidocaine gel (Xylestesin®, Cristália, São Paulo, Brazil) (Group Gel).

A standardized method was used to prepare the injection site and disinfect the skin using povidone iodine 10%. Patients from groups Drops and SC received a drop of proparacaine 0.5% before receiving a drop of povidone iodine 5%. For the patients from Group Gel, the gel was placed on the eye before receiving the drop of povidone iodine 5%. Patients from Group Drops received a second drop of proparacaine 0.5%, 5 minutes after the drop of povidone iodine 5%. For the patients from Group SC, a subconjunctival bleb of anesthesia was created by injecting 0.4 ml of lidocaine 1% into the subconjunctival space, posteriorly to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-ml syringe. After 5 minutes of the drop of povidone iodine 5%, sterile field and a lid speculum were placed. The injection site was measured with calipers to be 3.5 mm or 4.0 mm posterior to the superotemporal limbus, for pseudophakic and phakic eyes, respectively. A 30-gauge 1/2-inch needle was used to inject 0.05 ml of bevacizumab (Avastin, Genentech, Inc.). After the injection, mild pressure was applied with a swabstick over the injection site to reduce vitreous reflux and subconjunctival hemorrhage another a drop of povidone iodine 5% was applied.

Immediately following the injection, a nurse, who was masked to the treatment, explained the 100-mm visual analog scale (VAS) for pain (Figure 1) and questioned the patients' level of pain perceived during the injection. This assessment was repeated 10 minutes, 1 hour, 6 hours and 24 hours later, without visualization of their prior responses. Patients were also asked to grade their overall experience with the injection procedure as Excellent (5), Very good (4), Fair (3), Poor (2) or Awful (1). The physician evaluated the patients' eye movement during intravitreal injection into three levels: none or minimal (0), not compromising the injection (1), compromising the injection (2). Complications that occurred during or after the procedures were also recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Age: 18 years or older
  • Indications for injection included neovascular AMD, DME and cystoid macular edema (CME) secondary to RVO.

排除标准

  • Previous known allergic response to the topical anesthetics to be used.
  • Previous intravitreal injections of drugs other than anti-VEGF agents
  • Previous pars plana vitrectomy
  • Anterior segment conditions that could affect pain sensation, such as conjunctival irritation, active conjunctivitis or keratitis or bullous keratopathy
  • Patients using systemic analgesic or sedative medications

结局指标

主要结局

Pain experience and patient satisfaction after 3 different anesthetic approaches for intravitreal injections

时间窗: immediately after injection, 10 minutes, 1 hour, 6 hours and 24 hours later

Pain experience according the visual analogue scale (VAS), a scale of 0 to 10 (0 = no pain, 10 = worst pain ever). Patient satisfaction according the overall injection experience, graded by the patient as Excellent, Very Good, Fair, Poor, or Awful.

次要结局

未报告次要终点

研究者

发起方
Retina Clinic, Sao Paulo, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Costa de Andrade

Gabriel Costa de Andrade

Retina Clinic, Sao Paulo, Brazil

研究点 (2)

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