Effect on intraocular pressure of inj hyaluronidase used as an adjuvant to local anaesthesia for peribulbar block in cataract - a prospective randomized double blinded comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraocular pressure before and after peribulbar block with or without added inj hyaluronidase.
研究概览
简要总结
After getting institutional ethnic committee approval, CTRI registration and written informed consent from all 120 patients, fulfilling inclusion criteria undergoing cataract surgery under peribulbar block will be taken in our study. All patients will be allocated randomly according to the computer generated random numbers into two groups of 60 patients in each group. Group 1 (n= 60) will receive peribulbar block with adjuvant inj hyaluronidase and Group 2 (n= 60) will receive peribulbar block without inj hyaluronidase. For double blinding purpose, all study drug administration will be done by another anesthesiologist who followed opaque sealed envelope technique and will not be part of the study. Another Anesthesiologist will collect data of patients. Patients will also be blinded to the study drug.
All patients will have a pre operative full history taking and general physical examination. Vital parameters such as blood pressure, heart rate and random blood sugar level will be measured. Ophthalmic examination will be done by the ophthalmologist. Pre block (control) IOP will be measured by a hand held air puff tonometer. Before the procedure tropicamide 0.8% and Phenylephrine 5% dilating eye drops will be instilled into the eye to be operated as per protocol followed in our institution. The eye to be operated will be painted and draped with 5% povidone iodine soluion. A 24 gauge disposable needle will be used and site of injection will be the point between medial 2/3 and lateral 1/3 of lower orbital margin adjacent to infraorbital notch. After negative aspiration, 6 ml local anaesthetic mixture will be injected over 30-40 seconds Group 1 will receive Local anaesthetic mixture of 1:1 2% Lignocaine plus 0.5% Bupivacaine with added adjuvant inj hyaluronidase (50 IU/ml) . Group 2 will receive local anaesthetic mixture without added hyaluronidase. After injection globe will be massaged and gentle pressure will be applied for 1 min. IOP will be measured at four time points - pre block ( control ), post block after 1 min, 5 min and 15 mins. All the study parameters according to time interval will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I,II,III patients.
- •Normal IOP (10-20 mm Hg).
- •Normal baseline ECG.
- •BP less than 160/90 mm Hg.
- •CBG less than 200 mg/dl.
- •Axial length of globe is 22-25 mm and in gonioscopy patient has open angle.
- •Cataract Operation under peribulbar block.
排除标准
- •hypersensitivity to hyaluronidase.
- •hypersensitivity to any components of the injection.
- •pre existing ocular pathology, trauma or ocular movement restriction.
- •pre existing glaucoma, high myopia or hypermetropia, eveitis.
- •previous ocular surgery like vitrectomy, trabeculectomy.
- •patient at increased risk for thrombosis.
- •patient receiving salicylates, ACTH, cortisone, estrogen.
- •patients with profound cognitive impairment, apprehension, requiring sedatives and analgesics,.
- •unwillingness to participate in the study.
结局指标
主要结局
Intraocular pressure before and after peribulbar block with or without added inj hyaluronidase.
时间窗: Pre block and post block 1 min, 5 min,15 mins after block.
次要结局
- Vital parameters - HR, NIBP, SpO2(Pre block and post block every 3 mins.)
- Block quality(10 mins after block)
研究者
Dr Manisankar Nath
Jalpaiguri Govt Medical College and hospital