Cipto Mangunkusumo Central National Hospital
Central Jakarta, DKI Jakarta, 10430, Indonesia
NCT Number: NCT03046719
The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Central Jakarta, DKI Jakarta, 10430, Indonesia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drop Out criteria:
Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
Time frame: 2 months
The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).
Time frame: 2 months
The time for first requested post-operative additional analgesia was measured in minutes in the morning after the surgery
Time frame: 2 months
post-operative nausea / vomiting incidence
Indonesia University
Other
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