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临床试验/NCT04345172
NCT04345172已完成不适用

Lacrimal Dilator-Facilitated Incisionless Vs. Standard Sub-Tenon's Block: A Randomized, Prospective and Non-inferiority Comparative Study

Baskent University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019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
64
试验地点
2
主要终点
chemosis

研究概览

简要总结

Standard sub-Tenon's block involves incision (dissection) of conjunctiva and Tenon's capsule with the help of blunt scissors and forceps, insertion of a blunt sub-Tenon's cannula under the Tenon's capsule and injection of local anaesthetic agent. This block is frequently associated with minor complications such as chemosis and subconjunctival haemorrhage. Different variations of incisionless sub-Tenon's block including the use of lacrimal dilator have been described to reduce minor complications and facilitate insertion of blunt cannula. Lacrimal dilator creates a small aperture in the conjunctiva and Tenon's capsule thus avoids incision. After ethics approval, patients undergoing elective cataract surgery were enrolled to receive sub-Tenon's block performed without incision with a lacrimal dilator (Group LD) or with incision using Wescott scissors and blunt forceps (Group WS). All patients received 3 mL 2% lidocaine without any adjuvant. No sedation was administered. Demographic of the patients, duration of the procedure, analgesia (pain), akinesia, duration of the procedure intraoperative chemosis, subconjunctival haemorrhage on the first postoperative day. We aimed to compare lacrimal dilator-facilitated and standard sub-Tenon's block effectiveness and incidence of chemosis and subconjunctival haemorrhage.

详细描述

The patients were randomly allocated to receive STB performed with a lacrimal dilator (Group LD) and with a Wescott scissors (Group WS). Randomization was ensured by sealed envelopes prepared according to a computer-generated table and the envelopes were opened by the operator just before the sub-Tenon's block.

Study protocol Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted.

In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus. The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula .

In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space. The block was performed with the above sub-Tenon's cannula.

All patients received lidocaine 2%, 3 mL without any adjuvant. No sedative was administered. All the blocks and surgeries were performed by the same investigator, but block evaluations were made by another investigator who was blinded to the technique used. All patients were discharged on the day of surgery.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

triple blind

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing cataract surgery by phacoemulsification and intraocular lens implantation

排除标准

  • allergy to lidocaine, history of previous retinal and strabismus surgery, bleeding disorders and oral anticoagulant use, presence of glaucoma or high IOP, thick pterygia, any pathological condition that conjunctiva and Tenon's capsule cannot be lifted away from the sclera

结局指标

主要结局

chemosis

时间窗: 10 minutes after intervention

swelling of the conjunctiva

次要结局

  • subconjunctival haemorrhage(on the postoperative first day)

研究者

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

Oya Yalcin Cok

Professor

Baskent University

研究点 (2)

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