Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral LIdocaine 1%

NCT02215057 | Completed DMC

• 1 other identifier: 1479
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were performed deep into the orbit, but it is now accepted that peribulbar injections using shorter needles are safer. In the last few years, continuing concern over the rare but serious complications of sharp needle blocks has led to increasing interest in the use of sub-Tenon's blocks utilizing a blunt cannula 1-5. Even with the use of blunt canulae sub-Tenon's block, serious problems can still occur, especially in myopic patients with large axial length. In phakic IOL surgery,topical anesthesia has been used successfully for years. Topical anesthesia has several advantages over regional infiltrative techniques, the foremost of which is the abolition of any risk of inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient satisfaction, but still there are some patients that experience intraoperative discomfort. In this study we compared topical anesthesia alone with topical anesthesia plus intracameral lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be because of the direct action of lidocaine on the iris, which in turn causes muscle relaxation.

Conditions

Other Iris and Ciliary Body Disorders

Keywords

topical anesthesia; intracameral lidocaine; implantable collamer lens

Outcome Measures

Primary Outcomes (1)

• PAIN

  15 MINUTES

Study Arms (2)

Group 2

EXPERIMENTAL

topical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops

Drug: topical anesthesia

Group 1

EXPERIMENTAL

received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%'

Drug: topical anesthesia; Drug: topical anesthesia plus intracameral lidocaine 1%

Interventions

topical anesthesia DRUG

topical anesthetic drops and Group 2

Also known as: LOCAL ANESTHESIA

Group 1; Group 2

topical anesthesia plus intracameral lidocaine 1% DRUG

received topical anesthesia plus intracameral lidocaine 1%

Also known as: received topical anesthesia plus intracameral lidocaine 1%

Group 1

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any age
• calm patient
• agreed

You may not qualify if:

• co agulopathy anxious refusal

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Magrabi Aseer ,KSA

Khamis Mushait, West, 516, Saudi Arabia

Location

MeSH Terms

Interventions

Anesthesia; Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anesthesia, Conduction

Study Officials

• Hassan M Ali, Lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

SA (1)