Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
Primary Purpose
Cataract Surgery Anesthesia
Status
Withdrawn
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Cataract Surgery Anesthesia
Eligibility Criteria
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
Sites / Locations
- Hospitalitaliano de buenos aires
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topical
subtenon
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
intraoperative pain
Amount of pain as verbal analog scale. Be evaluated at the end of surgery
Full Information
NCT ID
NCT01344252
First Posted
April 26, 2011
Last Updated
March 2, 2023
Sponsor
Hospital Italiano de Buenos Aires
1. Study Identification
Unique Protocol Identification Number
NCT01344252
Brief Title
Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
Official Title
Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
April 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Italiano de Buenos Aires
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical
Arm Type
Experimental
Arm Title
subtenon
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
Primary Outcome Measure Information:
Title
number of subjects who prefer topical anesthesia.
Description
The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
intraoperative pain
Description
Amount of pain as verbal analog scale. Be evaluated at the end of surgery
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospitalitaliano de buenos aires
City
Caba
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
12. IPD Sharing Statement
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Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
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