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Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Bupivacaine 0,5%
NaCl 0,9%
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Retinal Detachment focused on measuring bupivacaine, intravitreal, analgesia, silicone oil removal, retinal detachment, subconjunctival

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cipto Mangunkusumo Central National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupivacaine 0,5%

NaCl 0,9%

Arm Description

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

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

Outcomes

Primary Outcome Measures

The degree of pain
The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).

Secondary Outcome Measures

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
Side Effects
post-operative nausea / vomiting incidence

Full Information

First Posted
February 5, 2017
Last Updated
February 5, 2017
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03046719
Brief Title
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Official Title
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
bupivacaine, intravitreal, analgesia, silicone oil removal, retinal detachment, subconjunctival

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine 0,5%
Arm Type
Active Comparator
Arm Description
Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches.
Arm Title
NaCl 0,9%
Arm Type
Placebo Comparator
Arm Description
Subjects received subconjunctival NaCl 0,9% in between stitches.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0,5%
Intervention Description
Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
Intervention Type
Drug
Intervention Name(s)
NaCl 0,9%
Intervention Description
NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
Primary Outcome Measure Information:
Title
The degree of pain
Description
The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
The time for first requested post-operative additional analgesia
Description
The time for first requested post-operative additional analgesia was measured in minutes in the morning after the surgery
Time Frame
2 months
Title
Side Effects
Description
post-operative nausea / vomiting incidence
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Cipto Mangunkusumo Central National Hospital
City
Central Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11756886
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.
Results Reference
background
PubMed Identifier
23794645
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.
Results Reference
background
PubMed Identifier
22225969
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.
Results Reference
background
PubMed Identifier
19411059
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.
Results Reference
background
PubMed Identifier
17216099
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.
Results Reference
background

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Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

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