Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

University of Indonesia (UI)

Status

Completed

Conditions

Retinal Detachment

Treatments

Drug: Bupivacaine 0,5%

Drug: NaCl 0,9%

Study type

Interventional

Funder types

Other

Identifiers

NCT03046719

IndonesiaUAnes009

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.