Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery

Phase 4

Withdrawn

• Conditions: Cataract Surgery Anesthesia
• Interventions: Drug: Lidocaine

• Registration Number: NCT01344252
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Status Verified: 2015-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Topical	Lidocaine	-
subtenon	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
number of subjects who prefer topical anesthesia.	1 month	The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)

Secondary Outcome Measures

Name	Time	Method
intraoperative pain	1 hour	Amount of pain as verbal analog scale. Be evaluated at the end of surgery

Trial Locations

Locations (2)

Hospitalitaliano de buenos aires; 🇦🇷 Caba, Argentina

Hospital Italiano de Buenos Aires; 🇦🇷 Ciudad Autonoma de Buenos Aires, Argentina