Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery
Recruitment status was Not yet recruiting
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Cataract Surgery Anesthesia |
Drug: Lidocaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Topical Jelly and Intracameral Anesthesia Versus Subtenon Anesthesia, in Cataract Surgery: Preference and Surgical Conditions |
- number of subjects who prefer topical anesthesia. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]The number of subjects who prefer topical anesthesia will measure at the end of the second surgery (1 month)
- intraoperative pain [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]Amount of pain as verbal analog scale. Be evaluated at the end of surgery
| Estimated Enrollment: | 41 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Topical |
Drug: Lidocaine
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
|
| Active Comparator: subtenon |
Drug: Lidocaine
We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Tomás - Ortiz Basso, MD | 00541149590200 ext 8551 | tomas.ortiz@hospitalitaliano.org.ar |
| Contact: Diego giunta, MD | diego.giunta@hospitalitaliano.org.ar |
| Argentina | |
| Hospitalitaliano de buenos aires | Not yet recruiting |
| Caba, Argentina, C1181ACH | |
| Contact: Tomas Ortiz Basso, MD 005449590200 ext 8551 tomas.ortiz@hiba.org.ar | |
| Hospital Italiano de Buenos Aires | Not yet recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH | |
| Contact: Tomas Ortiz Basso, MD 005449590200 ext 8551 tomas.ortiz@hospitalitaliano.org.ar | |
| Principal Investigator: Tomas Ortiz Basso, MD | |
More Information
No publications provided
| Responsible Party: | Hospital Italiano de Buenos Aires |
| ClinicalTrials.gov Identifier: | NCT01344252 History of Changes |
| Other Study ID Numbers: | 1686 |
| Study First Received: | April 26, 2011 |
| Last Updated: | April 28, 2011 |
| Health Authority: | Argentina: ANMAT. Administracion nacional de medicamentos, alimentos y tecnologia |
Additional relevant MeSH terms:
|
Cataract Lens Diseases Eye Diseases Anesthetics Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013