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临床试验/NCT03046719
NCT03046719已完成不适用

Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Indonesia University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The degree of pain

研究概览

简要总结

The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannule with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. Co-induction was done with midazolam 0,05 mg/kg and fentanyl 2 mcg/kg. Induction was done with propofol 1-2 mg/kg, followed by Laryngeal Mask insertion facilitated by atracurium 0,5 mg/kg. Maintenance was done with sevoflurane 1-2 vol%, O2:H2O = 1:2, flow 2 liter/minute. Surgery started. After final stitching, Group 1 received subconjunctival bupivacaine 0,5% 2,5ml in between stitches; Group 2 received subconjunctival NaCl 0,9% in between stitches. Both groups received paracetamol 20 mg/kgBW IV as post-operative analgesics. Hemodynamic, pain degree (using Visual Analog Scale / VAS), and nausea/vomiting incidence, and the time for first requested additional analgesia were recorded. Data was analyzed using SPSS (Statistical Package for Social Scientist), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 18-60 years old, with ASA physical status I-II and BMI 18,5-30 kg/m2 who were planned to do intravitreal silicone evacuation surgery.
  • Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

排除标准

  • Subjects with history of post-operative chronic pain
  • Subjects with history of pre-operative long term use of analgesic
  • Subjects with history of local anesthetics allergy, pregnant subjects
  • Subjects with ambulation operation
  • Subjects with glaucoma or ocular hypertension
  • Subjects with cognition dysfunction or communication disturbance
  • Subjects with additional surgery other than silicone oil removal
  • Drop Out criteria:
  • Subjects with intraoperative complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
  • Subjects with post-operative intraocular pressure > 22mmHg.

研究组 & 干预措施

Bupivacaine 0,5%

Active Comparator

Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches.

干预措施: Bupivacaine 0,5% (Drug)

NaCl 0,9%

Placebo Comparator

Subjects received subconjunctival NaCl 0,9% in between stitches.

干预措施: NaCl 0,9% (Drug)

结局指标

主要结局

The degree of pain

时间窗: 2 months

The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).

次要结局

  • The time for first requested post-operative additional analgesia(2 months)
  • Side Effects(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. dr. Aida Rosita Tantri SpAn-KA

Consultant, Anesthesiologist

Indonesia University

研究点 (1)

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