Cataract Surgery AnesthesiaPhase 4NCT01344252
Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
A Phase 4 study testing Lidocaine in people with Cataract Surgery Anesthesia, run by Hospital Italiano de Buenos Aires at 2 sites in Argentina.
Trial summary
The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract Surgery Anesthesia
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesArgentina
- Study dates
- Apr 2011to not given
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral cataract
Who cannot join
- refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH
Hospitalitaliano de buenos aires
CABA, C1181ACH
About this study
Official title: Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions
The options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.
Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.
Read more
Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.
Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery
- Conditions
- Cataract Surgery Anesthesia
- Being tested
- Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Topical | Experimental | Not described Receives: Drug: Lidocaine |
| subtenon | Active comparator | Not described Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of subjects who prefer topical anesthesia.
The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)
Measured: 1 month
Secondary outcomes (1)
intraoperative pain
Amount of pain as verbal analog scale. Be evaluated at the end of surgery
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract Surgery AnesthesiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomás Ortíz Basso, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344252
- Sponsor's protocol ID
- 1686
- Status last verified
- Mar 2015
- First submitted
- 26 Apr 2011
- Last updated
- 6 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions
- ClinicalTrials.gov ID
- NCT01344252
- Acronym / sponsor ID
- 1686
- Conditions
- Cataract Surgery Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Apr 2011
- First posted
- 29 Apr 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 options for anesthesia in cataract surgery described are: general, regional or local. The local strategy, it may be by periocular blocking(subtenon, peribulbar or retrobulbar), subconjunctival or topical. The risks faced by subconjunctival, peribulbar or retrobulbar, have made subtenon and topical strategies the most used. Likewise, to improve the effectiveness of the topical strategy was added gel topical lidocaine and intracameral dose of lidocaine.
Subtenon and topical anesthesia are two safe strategies and there were performed multiple studies showing that both are effective in controlling pain, but showing a slight superiority of subtenon. This difference does not appear to be clinically significant. In turn, the addition of gel and intracameral anesthesia, improved pain control. However, lack evidence to compare patient preference when using topical gel and intracameral anesthesia versus sub-Tenon anesthesia.
Multiple advantages has the topical anesthesia. Besides being a safe strategy for the patient, offers a rapid visual recovery, no generates blepharoptosis or diplopia postoperatively, subconjunctival hemorrhage and chemosis.
Because of this the investigators plan to conduct a study comparing the efficacy of gel topical and intracameral anesthesia versus subtenon anesthesia in cataract surgery with scleral incision, assessing the patient's preference Hypothesis: Topical administration of lidocaine in gel and intracameral anesthesia is a better strategy that subtenon anesthesia in cataract surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical | Experimental | Drug: Lidocaine |
| subtenon | Active comparator | Drug: Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bilateral cataract
Key exclusion criteria (1 listed)
- refuse to participate, high surgical risk (ASA 4 or 5), allergy to lidocaine or other amide local anesthesics, inability to understand the informed consent, coagulation abnormalities, prior ophthalmologic surgery, small pupil, Fuchs dystrophy, lens luxation, uveitis
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 |
|---|---|---|
| LidocaineWe will made anesthesia with topical lidocaine and compared with subtenon anesthesia | Drug | Topical, subtenon |
Primary outcome
number of subjects who prefer topical anesthesia.
Time frame: 1 month
The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)
1 secondary outcome
intraoperative pain
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
2 sites 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 Cataract Surgery Anesthesia, run by Hospital Italiano de Buenos Aires at 2 sites in Argentina.
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: withdrawn, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
number of subjects who prefer topical anesthesia. (time frame: 1 month). 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 6 Mar 2023.