Clinical trial NCT03046719: Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Official title: Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: bupivacaine
intravitreal
analgesia
silicone oil removal
retinal detachment
subconjunctival
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The degree of pain
timeFrame: 2 months
Secondary outcomes:
measure: The time for first requested post-operative additional analgesia
timeFrame: 2 months
measure: Side Effects
timeFrame: 2 months
Other outcomes:
Locations:
city: Central Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: DKI Jakarta
Study officials:
References:
citation: Fekrat S, Elsing SH, Raja SC, Campochiaro PA, de Juan E Jr, Haller JA. Eye pain after vitreoretinal surgery: a prospective study of 185 patients. Retina. 2001;21(6):627-32. doi: 10.1097/00006982-200112000-00010.
citation: Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.
citation: Wandner LD, Scipio CD, Hirsh AT, Torres CA, Robinson ME. The perception of pain in others: how gender, race, and age influence pain expectations. J Pain. 2012 Mar;13(3):220-7. doi: 10.1016/j.jpain.2011.10.014. Epub 2012 Jan 5.
citation: Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley JL 3rd. Sex, gender, and pain: a review of recent clinical and experimental findings. J Pain. 2009 May;10(5):447-85. doi: 10.1016/j.jpain.2008.12.001.
citation: Belmonte C, Aracil A, Acosta MC, Luna C, Gallar J. Nerves and sensations from the eye surface. Ocul Surf. 2004 Oct;2(4):248-53. doi: 10.1016/s1542-0124(12)70112-x.