Comparison Between Ropivacaine and Bupivacaine in Deep Topical Fornix Nerve Block Anesthesia in Patients Undergoing Cataract Surgery by Phacoemulsification.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measure level of pain and discomfort during surgery
研究概览
简要总结
Deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. In this study the investigators intend to compare ropivacaine and bupivacaine in various parameters during phacoemulsification.
详细描述
Prospective, study will be conducted on 100 patients undergoing elective cataract surgery by phacoemulsification under Deep topical fornix nerve block at Government medical college, Haldwani, India.
Written informed consent to participate in the study will be taken from all the patients.
Patients will be randomly allocated into two groups, Groups B (Bupivacaine: n=50) and Group R (Ropivacaine: n =50).
Deep topical fornix nerve block (DTFNB) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. The sponges are to be removed after 15-20 minutes. The anesthetic effect will be tested by grasping the limbus with Castroviejo 0.12 tissue forceps. No sedative systemic medications will be given to patients perioperatively.
All surgeries will be performed by the same surgeon. Both patients and surgeon will be blind to which anesthetic agent would be used. A 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. The nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. Foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anaesthesiologists Physical Status classification system (ASA I-II) to undergo planned cataract surgery by phacoemulsification.
排除标准
- •Younger than 50 years,
- •Had any psychiatric illness (including significant anxiety),
- •Nystagmus,
- •Insufficient pupil dilatation,
- •Very hard cataracts (NS 4-5),
- •Allergy to local anaesthetics,
- •Inability to understand language or
- •Patient refuses the topical anaesthesia technique
研究组 & 干预措施
Group B
Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
干预措施: Deep Topical Fornix Nerve block anesthesia (Procedure)
Group B
Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
干预措施: Bupivacaine (Drug)
Group B
Deep Topical Fornix Nerve block anesthesia using bupivacaine and proparacaine
干预措施: Proparacaine (Drug)
Group R
Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
干预措施: Deep Topical Fornix Nerve block anesthesia (Procedure)
Group R
Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
干预措施: Ropivacaine (Drug)
Group R
Deep Topical Fornix Nerve block anesthesia using ropivacaine and proparacaine
干预措施: Proparacaine (Drug)
结局指标
主要结局
Measure level of pain and discomfort during surgery
时间窗: 1 hours
A simple pain scoring system will be used during the surgery (0: No pain; 1: Discomfort; 2: Pain). Assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration
次要结局
- Level of surgeon satisfaction(1 hour)
- Number of patients where Supplemental anaesthesia was given(1 hour)
- Incidence of Surgical complications(1 hour)
研究者
Dr Rahul Varshney
Post Graduate
Government Medical College, Haldwani