Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

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

Detailed Description
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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.

Official Title
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Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: Bupivacaine 0,5%
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine 0,5%<br>Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches. | Drug: Bupivacaine 0,5%<br>* Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches<br>|
| Placebo Comparator: NaCl 0,9%<br>Subjects received subconjunctival NaCl 0,9% in between stitches. | Drug: NaCl 0,9%<br>* NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of pain | The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for first requested post-operative additional analgesia | The time for first requested post-operative additional analgesia was measured in minutes in the morning after the surgery | 2 months | 
| Side Effects | post-operative nausea / vomiting incidence | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subconjunctival, analgesia, silicone oil removal, retinal detachment, bupivacaine, intravitreal