Pain, AcuteEarly Phase 1NCT05069350
Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
A Early Phase 1 study testing bupivacaine 0.5% and oxubuprocaine in people with Pain, Acute, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- bupivacaine 0.5% and oxubuprocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 Aug 2022
- Phase
- Early Phase 1
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients between 30 to 70 years
Who cannot join
- uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections
comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.
Read the detailed description
In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection
All patients are informed that they are going to receive topical anaesthetic agent before the IVI.
pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.
- Conditions
- Pain, Acute
- Being tested
- bupivacaine 0.5% and oxubuprocaine
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 0.5% and oxubuprocaineDrug
using each drug as surface anesthesia before intravitreal injections
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine 0.5% | Experimental | Not described Receives: Drug: bupivacaine 0.5% and oxubuprocaine |
| oxybuprocaine | Experimental | Not described Receives: Drug: bupivacaine 0.5% and oxubuprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
verbal pain numerical scaling
11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomized syudy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069350
- Sponsor's protocol ID
- Topical anesthesia in IVI
- Status last verified
- Sep 2022
- First submitted
- 14 Sep 2021
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections
- ClinicalTrials.gov ID
- NCT05069350
- Acronym / sponsor ID
- Topical anesthesia in IVI
- Conditions
- Pain, Acute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Oct 2021 (actual)
- 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.
comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.
Detailed description
In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection
All patients are informed that they are going to receive topical anaesthetic agent before the IVI.
pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double blinded randomized syudy
| Arm | Type | Receives |
|---|---|---|
| bupivacaine 0.5% | Experimental | Drug: bupivacaine 0.5% and oxubuprocaine |
| oxybuprocaine | Experimental | Drug: bupivacaine 0.5% and oxubuprocaine |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients between 30 to 70 years
Key exclusion criteria (1 listed)
- uncooperative patients
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% and oxubuprocaineusing each drug as surface anesthesia before intravitreal injections | Drug | bupivacaine 0.5%, oxybuprocaine |
Primary outcome
verbal pain numerical scaling
Time frame: 10 minutes
11 point scale from 0-10 zero measns No pain 10 means severe unbearable pain
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 13 Sep 2022.
- Individual participant dataSharing planned: No
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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 Early Phase 1 study testing bupivacaine 0.5% and oxubuprocaine in people with Pain, Acute, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
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 1 inclusion and 1 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 13 Sep 2022. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
verbal pain numerical scaling (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2022.