Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Retinal Detachment Clinical Trial

Official title:

Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03046719
• Other study ID #: IndonesiaUAnes009
• Status: Completed
• Phase: N/A
• First received: February 5, 2017
• Last updated: February 5, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Drug:
• Bupivacaine 0,5%
Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
• NaCl 0,9%
NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Central Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain	The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).	2 months
Secondary	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
Secondary	Side Effects	post-operative nausea / vomiting incidence	2 months