Retinal DetachmentPhase 4NCT01417572
Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
A Phase 4 study testing lidocaine in people with Retinal Detachment, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Sep 2011
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Retinal detachment
- Retinal tear less than 3 hour clock
Who cannot join
- Vitreous hemorrhage
- Proliferative vitreoretinopathy
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan, Isfahan, 7864329800
amin masjedi, MD, +983112211915, Masjedi1827@gmail.com
Amin Masjedi, MD
About this study
The purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.
- Conditions
- Retinal Detachment
- Being tested
- lidocaine
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
to evaluate the effect of lidocaine on oculocardiac reflex during the surgery
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Experimental | Not described Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative heart rate measurement
Measured: 6 month
decrease in pain and nausea,vomiting after surgery
Measured: 6 month
decrease in ocr after application of topical lidocaine
Measured: 6 month
postoperative nausea and vommitting
Measured: 6 month
postoperative pain
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417572
- Sponsor's protocol ID
- 199
- Status last verified
- Jan 2010
- First submitted
- 9 Aug 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Local Application of Lidocaine During Scleral Buckling Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01417572
- Acronym / sponsor ID
- 199
- Conditions
- Retinal Detachment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 16 Aug 2011 (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 purpose of this study is to evaluate the effect of topical lidocaine in scleral buckling surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Experimental | Drug: lidocaine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Retinal detachment
- Retinal tear less than 3 hour clock
Key exclusion criteria (2 listed)
- Vitreous hemorrhage
- Proliferative vitreoretinopathy
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 |
|---|---|---|
| lidocaineto evaluate the effect of lidocaine on oculocardiac reflex during the surgery | Drug | lidocaine |
Primary outcome
intraoperative heart rate measurement
Time frame: 6 month
decrease in pain and nausea,vomiting after surgery
Time frame: 6 month
decrease in ocr after application of topical lidocaine
Time frame: 6 month
postoperative nausea and vommitting
Time frame: 6 month
postoperative pain
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Surgical Procedure Efficiency Evaluation stuDy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine in people with Retinal Detachment, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2011. 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 Iran. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amin Masjedi, MD (+983112211915, Masjedi1827@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative heart rate measurement (time frame: 6 month). The study lists 5 primary outcomes in all. 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 16 Aug 2011.