|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03046719 |
|
Date of registration:
|
05/02/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
|
|
Scientific title:
|
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal |
|
Date of first enrolment:
|
September 2016 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03046719 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Indonesia
| | | | | | | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Retinal Detachment
|
|
Intervention(s)
|
|
Drug: Bupivacaine 0,5%
|
|
Drug: NaCl 0,9%
|
|
Primary Outcome(s)
|
|
The degree of pain
[Time Frame: 2 months]
|
|
Secondary Outcome(s)
|
|
The time for first requested post-operative additional analgesia
[Time Frame: 2 months]
|
|
Side Effects
[Time Frame: 2 months]
|
|
Secondary ID(s)
|
|
IndonesiaUAnes009
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|