Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

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

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Drug: Bupivacaine 0,5%; Drug: NaCl 0,9%

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Central Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: intravitreal; analgesia; bupivacaine; retinal detachment; subconjunctival; silicone oil removal
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IndonesiaUAnes009