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临床试验/NCT03312959
NCT03312959Unknown4 期

Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
试验地点
1
主要终点
The onset and duration of lid and globe akinesia

研究概览

简要总结

Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.

详细描述

Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.

However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.

Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with American Society of Anesthesiology (ASA) I or II.
  • 30-80 years old
  • Patients scheduled for elective unilateral posterior segment surgeries.

排除标准

  • Patient's refusal.
  • orbital deformity
  • axial length( >28 mm )
  • increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) > 1.5
  • allergy to local anesthetics, mentally retarded patients

研究组 & 干预措施

hyperbaric bupvacaine group

Experimental

Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline

干预措施: hyperbaric bupvacaine in Peribulbar block (Drug)

isobaric bupvacaine group

Active Comparator

Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline

干预措施: isobaric bupvacaine in Peribulbar block (Drug)

结局指标

主要结局

The onset and duration of lid and globe akinesia

时间窗: 12 hours postoperative

scoring the ocular movements in each direction of gaze

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

Hassan Mohamed Ali

lecturer of anesthesia

Cairo University

研究点 (1)

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Heavy Bupivacaine in Peribulbar Block | 临床试验