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

NCT01344252 | Withdrawn Phase 4

• 1 other identifier: 1686
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Conditions

Cataract Surgery Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• intraoperative pain

  1 hour

Study Arms (2)

Topical

EXPERIMENTAL

Drug: Lidocaine

subtenon

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

Lidocaine DRUG

We will made anesthesia with topical lidocaine and compared with subtenon anesthesia

Topical; subtenon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bilateral cataract

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (2)

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Hospitalitaliano de buenos aires

CABA, C1181ACH, Argentina

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Last Updated: March 6, 2023

Record last verified: 2015-03

Locations

AR (2)