Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01344252
Other study ID # 1686
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date April 2011

Study information

Verified date March 2015
Source Hospital Italiano de Buenos Aires
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia

Locations

Country Name City State
Argentina Hospitalitaliano de buenos aires Caba
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

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