Cataract Surgery Anesthesia Clinical Trial
Official title:
Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions
NCT number | NCT01344252 |
Other study ID # | 1686 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2011 |
Verified date | March 2015 |
Source | Hospital Italiano de Buenos Aires |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - bilateral cataract Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospitalitaliano de buenos aires | Caba | |
Argentina | Hospital Italiano de Buenos Aires | Ciudad Autonoma de Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Hospital Italiano de Buenos Aires |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 1 month | |
Secondary | intraoperative pain | Amount of pain as verbal analog scale. Be evaluated at the end of surgery | 1 hour |