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
|Condition or disease||Intervention/treatment||Phase|
|Retinal Detachment||Drug: Bupivacaine 0,5% Drug: NaCl 0,9%||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
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
- 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).
- 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
- Side Effects [ Time Frame: 2 months ]post-operative nausea / vomiting incidence
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
|Cipto Mangunkusumo Central National Hospital|
|Central Jakarta, DKI Jakarta, Indonesia, 10430|