Comparison of Analgetic Effect of Two Solutions of Intracameral Anesthesia During Cataract Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The mean pain score measured with VAS Pain
研究概览
简要总结
Purpose: The aim of the study was to compare the analgetic effect of two solutions of intracameral anesthesia in patients undergoing cataract surgery and assess the factors influencing the patients' postoperative activities.
Methods: In this prospective, single-blind, randomized study, a group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic. The analgetic effect of these two anesthetic methods was evaluated using psychological tools - Visual Analog Scale for Pain (VAS Pain) and Brief Pain Inventory-short form (BPI) on the next day after the surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 18 years
- •best corrected visual acuity (BCVA) of 0.2 logMAR or worse
- •and agreement for taking part in the study
排除标准
- •depressive disorder or expected compliance problems (known psychiatric disease)
- •ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission
- •daily analgesic treatment
- •intake of additional rescue medications due to the pain after surgery
- •omitting postoperative visit
- •no consent to complete the survey
- •The patients who later needed additional medications for pain relief
研究组 & 干预措施
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: lignocaine (Drug)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Phacoemulsyfication (Procedure)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Intraocular lens implantation (Procedure)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Visual Analog Scale for Pain (Behavioral)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Brief Pain Inventory-short form (Behavioral)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Best corrected visual acuity measurment (Diagnostic Test)
Mydrane group
Patients were randomly selected to the group receiving intracameral 0.2 ml Mydrane (a solution of 1% lidocaine and 0.025% of adrenaline ) during phacoemulsification.
干预措施: Slit-lamp biomicroscopy (Diagnostic Test)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: lignocaine (Drug)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Phacoemulsyfication (Procedure)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Intraocular lens implantation (Procedure)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Visual Analog Scale for Pain (Behavioral)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Brief Pain Inventory-short form (Behavioral)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Best corrected visual acuity measurment (Diagnostic Test)
Reference group
Patients were randomly selected to the group receiving intracameral a combination of intracameral solution of lignocaine 1% and adrenalin 0.025% (0.2 ml) during phacoemulsification.
干预措施: Slit-lamp biomicroscopy (Diagnostic Test)
结局指标
主要结局
The mean pain score measured with VAS Pain
时间窗: postoperatively (the next day after surgery- 24 hours)
The mean pain score measured with Visual Analog Scale for Pain (equivalent to 10 degrees).O points represented no pain and that the 10 points represented the most intense pain he or she felt throughout the surgical procedure.
The range of pain was measured on the next day after surgery with BPI-short
时间窗: the next day after surgery (24 hours)
The the mean severity score, the pain interference mean score was measured with Brief Pain Inventory-short form (BPI-short form). BPI is one of the most widely used measurement tools for assessing clinical pain. It contains two domains that measure pain intensity (severity) and the impact of pain on functioning (interference). In the current study, BPI was used to evaluate the severity of pain and the impact of pain on daily function in the previous 24 h. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.
次要结局
未报告次要终点