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

August 2, 2016 updated by: Hassan Mohamed Ali, Cairo University

Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral Lidocaine 1% in Patients Undergoing Implantable Collamer Lens (ICL) Procedure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

were enrolled in this study after obtaining approval from the institutional ethical committee and written patients consent. We estimated our sample size based on a method described by Lerman. A sample size of 45 will detect a 20% difference between each group; this will give an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we decided to increase the number of patients in each group to 51.All patients were assessed and only those who were deemed suitable for topical and intracameral lidocaine 1% were included in the study.Very anxious patients were omitted from the study.

We are planning a study of matched sets of patients receiving the experimental and control treatments with 1 matched control(s) per experimental subject. Prior data indicate that the probability of a treatment failure among controls is 0.05 and the correlation coefficient for exposure between matched experimental and control subjects are 0.1. If the true odds ratio for failure in experimental subjects relative to control subjects is 0.1, we will need to study 51 experimental subjects with 1 matched control(s) per experimental subject to be able to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The Type I error probability associated with this test of this null hypothesis is 0.3.

All the operations were done by one surgeon (SE).Patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic drops .

Pain was estimated by the patient using a simple pain score: no pain =0; that does not interfere with the surgical technique, discomfort=1; the surgical technique is performed with difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was done during different stages of surgery: lid retraction while inserting a speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates, irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding, tucking of trailing footplates then side port incision and tucking of leading footplates, MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • West
      • Khamis Mushayt, West, Saudi Arabia, 516
        • Magrabi Aseer ,KSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • any age
  • calm patient
  • agreed

Exclusion Criteria:

  • co agulopathy anxious refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
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
topical anesthetic drops and Group 2
Other Names:
  • LOCAL ANESTHESIA
Experimental: Group 1
received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%'
Drug: topical anesthesia
topical anesthetic drops and Group 2
Other Names:
  • LOCAL ANESTHESIA
Drug: topical anesthesia plus intracameral lidocaine 1%
received topical anesthesia plus intracameral lidocaine 1%
Other Names:
  • received topical anesthesia plus intracameral lidocaine 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PAIN
Time Frame: 15 MINUTES
15 MINUTES

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1479 (CSL Behring)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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