Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-12-31

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

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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.

Conditions

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Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupivacaine 0,5%

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

Group Type ACTIVE_COMPARATOR

Bupivacaine 0,5%

Intervention Type DRUG

Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

NaCl 0,9%

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

Group Type PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type DRUG

NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

Interventions

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Bupivacaine 0,5%

Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

Intervention Type DRUG

NaCl 0,9%

NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No