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临床试验/CTRI/2025/08/093852
CTRI/2025/08/093852尚未招募3 期

Comparison of efficacy of 2% lidocaine and 0.5% bupivacaine with 2% lidocaine and 0.75% ropivacaine in peribulbar block for cataract surgery.

Athira Ajayghosh1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2025年9月8日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
184
试验地点
1
主要终点
Sample size is calculated and found to be 184, divided into two groups, 82 in each. Sensory and motor blockade onset were assessed at regular intervals, and postoperative analgesia duration was measured.

研究概览

简要总结

Cataract surgery is commonly performed under regional anaesthesia using peribulbar blocks. The combination of local anaesthetic agents significantly affects the onset, duration, and efficacy of anaesthesia. This study aimed to compare the efficacy of peribulbar anaesthesia using 2percent lidocaine with 0.75percent ropivacaine versus 2percent lidocaine with 0.5percent bupivacaine in terms of sensory blockade onset, motor blockade onset, and postoperative analgesia duration. Study to be conducted on 164 patients undergoing cataract surgery, who are divided into two groups. One group receive an 8 ml mixture of 2percent lidocaine and  0.75percent ropivacaine, while the control group receive 2percent lidocaine and 0.5percent bupivacaine. The peribulbar block is administered while the patients maintained a primary gaze. Gentle massage is applied to facilitate the spread of the anaesthetic. Sensory block wis assessed by loss of corneal sensation with cotton whisp at 2, 4, 6, 8, and 10 min intervals after injection. Onset of sensory block is taken as time from injection to loss of corneal sensation. Motor block is evaluated in the four quadrants using a 3-point scoring system [Akinesia (ocular movement lesser than1mm), reduced movement (ocular movement greater than 1mm but lesser than 4mm) and normal movements (ocular movement greater than 4mm)]. A total score of less than or equal to 2 indicates a successful block. Once successful block is attained, no further assessment made. Haemodynamic parameters, including systolic, diastolic, and mean arterial pressures, heart rate, and oxygen saturation to be monitered . The quality of the surgical anaesthesia is graded as excellent (no pain), good (minimal pain), or poor (failed block). Postoperatively, pain is assessed using the Visual Analogue Scale (VAS) every 15 min until the score reached greater than or equal to 3. The duration of effective analgesia is recorded from the time of the peribulbar block to the point when the VAS score reached greater than or equal 3. The resolution of motor blockade cant be assessed because the patient’s eyes bandage postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
44.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with immature or mature cataracts, patients aged above 44 years old and patients experiencing cataract-related symptoms, such as cloudy vision, light sensitivity, or increasing short-sightedness, who have a maximum corrected visual acuity of 6/60 or higher.

排除标准

  • Local sepsis, glaucoma, serious impairment of coagulation, orbital abnormalities, patient’s refusal, un-cooperative patients and patients are unable to lie supine for a long time.

结局指标

主要结局

Sample size is calculated and found to be 184, divided into two groups, 82 in each. Sensory and motor blockade onset were assessed at regular intervals, and postoperative analgesia duration was measured.

时间窗: Peribulbar block is given. Sensory block is assessed by corneal sensation at 2min intervals till loss of sensation. Motor block is evaluated at 2min interval. Postoperatively pain is assessed using the VAS every 15 min. The duration of effective analgesia is recorded from the time of block to point when VAS score reached more than or equal 3.

次要结局

未报告次要终点

研究者

发起方
Athira Ajayghosh
申办方类型
Other [Primary investigator]
责任方
Principal Investigator
主要研究者

Athira Ajayghosh

SRM medical college hospital and research centre

研究点 (1)

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