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Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal

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ClinicalTrials.gov Identifier: NCT03046719
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University

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

Condition or disease Intervention/treatment Phase
Retinal Detachment Drug: Bupivacaine 0,5% Drug: NaCl 0,9% Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
Study Start Date : September 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The degree of pain [ Time Frame: 2 months ]
    The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).


Secondary Outcome Measures :
  1. The time for first requested post-operative additional analgesia [ Time Frame: 2 months ]
    The time for first requested post-operative additional analgesia was measured in minutes in the morning after the surgery

  2. Side Effects [ Time Frame: 2 months ]
    post-operative nausea / vomiting incidence



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046719


Locations
Indonesia
Cipto Mangunkusumo Central National Hospital
Central Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications:
Responsible Party: Dr. dr. Aida Rosita Tantri SpAn-KA, Consultant, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03046719     History of Changes
Other Study ID Numbers: IndonesiaUAnes009
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017

Keywords provided by Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University:
bupivacaine
intravitreal
analgesia
silicone oil removal
retinal detachment
subconjunctival

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents