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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hospital Italiano de Buenos Aires.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01344252
First received: April 26, 2011
Last updated: April 28, 2011
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344252

Contacts
Contact: Tomás - Ortiz Basso, MD 00541149590200 ext 8551 tomas.ortiz@hospitalitaliano.org.ar
Contact: Diego giunta, MD diego.giunta@hospitalitaliano.org.ar

Locations
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         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014