Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Not Applicable

Completed

• Conditions: Retinal Detachment
• Interventions: Drug: NaCl 0,9%; Drug: Bupivacaine 0,5%

• Registration Number: NCT03046719
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-05
• Study First Submitted QC: 2017-02-05
• Last Update Submitted: 2017-02-05
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0,9%	NaCl 0,9%	Subjects received subconjunctival NaCl 0,9% in between stitches.
Bupivacaine 0,5%	Bupivacaine 0,5%	Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches.

Primary Outcome Measures

Name	Time	Method
The degree of pain	2 months	The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
The time for first requested post-operative additional analgesia	2 months	The time for first requested post-operative additional analgesia was measured in minutes in the morning after the surgery
Side Effects	2 months	post-operative nausea / vomiting incidence

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Central Jakarta, DKI Jakarta, Indonesia