Retinal DetachmentNCT03046719
Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
A study testing Bupivacaine 0,5% and NaCl 0,9% in people with Retinal Detachment, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Bupivacaine 0,5% and NaCl 0,9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- Sep 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Central Jakarta, DKI Jakarta, 10430
About this study
The study aimed to investigate the effectivity of bupivacaine 0,5% as post-operative analgesia in intravitreal silicone evacutaion surgery
Read the 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.
- Conditions
- Retinal Detachment
- Being tested
- Bupivacaine 0,5%, NaCl 0,9%
- Keywords
- bupivacaine, intravitreal, analgesia, silicone oil removal, retinal detachment, subconjunctival
- Medical subject headings
- Retinal Detachment, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0,5%Drug
Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
NaCl 0,9%Drug
NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine 0,5% | Active comparator | Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches. Receives: Drug: Bupivacaine 0,5% |
| NaCl 0,9% | Placebo comparator | Subjects received subconjunctival NaCl 0,9% in between stitches. Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain
The degree of pain was measured in the morning after the surgery by Visual Analog Scale (VAS).
Measured: 2 months
Secondary outcomes (2)
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
Measured: 2 months
Side Effects
post-operative nausea / vomiting incidence
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startSep 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Aida Rosita Tantri SpAn-KA, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046719
- Sponsor's protocol ID
- IndonesiaUAnes009
- Status last verified
- Feb 2017
- First submitted
- 5 Feb 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
Publications
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.
PubMed 11756886Bartley 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.
PubMed 23794645Wandner 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.
PubMed 22225969Fillingim 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.
PubMed 19411059Belmonte 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.
PubMed 17216099
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subconjunctiva Bupivacaine as Analgesia in Intravitreal Silicone Oil Removal
- ClinicalTrials.gov ID
- NCT03046719
- Acronym / sponsor ID
- IndonesiaUAnes009
- Conditions
- Retinal Detachment
- Keywords
- bupivacaine, intravitreal, analgesia, silicone oil removal, retinal detachment, subconjunctival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine 0,5% | Active comparator | Drug: Bupivacaine 0,5%Subjects received subconjunctival bupivacaine 0,5% 2,5ml in between stitches. |
| NaCl 0,9% | Placebo comparator | Drug: NaCl 0,9%Subjects received subconjunctival NaCl 0,9% in between stitches. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine 0,5%Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches | Drug | Bupivacaine 0,5% |
| NaCl 0,9%NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches | Drug | NaCl 0,9% |
Primary outcome
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).
2 secondary outcomes
The time for first requested post-operative additional analgesia
Time frame: 2 months
Side Effects
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 11756886Fekrat 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.
- Background: PubMed 23794645Bartley 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.
- Background: PubMed 22225969Wandner 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.
- Background: PubMed 19411059Fillingim 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.
- Background: PubMed 17216099Belmonte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0,5% and NaCl 0,9% in people with Retinal Detachment, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of pain (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046719, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.