Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain

December 23, 2014 updated by: Wai-Ching Lam, University Health Network, Toronto

Cefazolin-Lidocaine Solution for Reducing Pain Associated With Subconjunctival Antibiotic Prophylaxis in Vitreo-Retinal Surgery

In retinal surgery, endophthalmitis is a sight-threatening eye infection that could complicate patient vision after the operation. At Toronto Western Hospital, for retinal surgery (operating at the back of the eye) it is common practice to administer an antibiotic (cefazolin) at the end of surgery, to reduce the risk of post-operative endophthalmitis. The antibiotic is administered by injection underneath the part of the eye called the conjunctiva. However, this antibiotic injection is often associated with high levels of post-operative pain. Previous studies have observed a reduction of this pain by injecting an anesthetic (lidocaine) in the subconjunctival space before the antibiotic. This study will seek to examine whether mixing 2% lidocaine with cefazolin before its injection will reduce post-operative pain in the retinal surgery setting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endophthalmitis is a sight threatening eye infection that can complicate any type of intra-ocular surgery including vitreo-retinal surgery. The incidence, risk factors, management, microbiology and prognosis of endophthalmitis following vitreo-retinal surgery has been well described by a prospective international study, which demonstrated that this complication is quite rare but has a poor prognosis(1,2).

It is a common practice to administer antibiotic at the end of surgery(3), to reduce the risk of post-operative endophthalmitis. In Canada and Europe for anterior segment surgery, intracameral injection of an antibiotic is a common practice(4). In vitreo-retinal surgery, the anterior segment is often not breached, so rather than the antibiotic being delivered into the anterior chamber, it is administered by subconjunctival injection. However, such subconjunctival injection of antibiotic, such as cefuroxime (a second generation cephalosporin) is often associated with high levels of post-operative pain(5).

Local anesthesia for vitreo-retinal surgery is routinely achieved by either subtenon or retro-bulbar regional anaesthesia. Vitreo-retinal surgery at Toronto Western Hospital typically is performed with retro-bulbar anaesthesia, which involves the transcutaneous injection of anesthetic solution, often 2% lidocaine and 0.5% marcain, into the retrobulbar space using a needle6. At the end of surgery, subconjunctival cefazolin (Ancef) and steroid(Solucortef) are given, and surgeons have noticed that this often appears to cause discomfort in the end of surgery.

Although previous study has explored the reduction of pain through the use of buffered lidocaine injected in the subconjunctival space before cefuroxime for cataract surgery(5), the utility of mixing 2% lidocaine with cefazolin before subconjunctival injection has not yet been evaluated. This may serve as an effective method of lowering pain associated with cefazolin delivery in the retinal surgical setting.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is above the age of 18,
  • Patient requires retinal surgery,
  • Requires retro-bulbar anaesthesia for vitreo-retinal surgery,
  • Patient is able to provide consent to the study

Exclusion Criteria:

  • Patient is cognitively incapable of performing the study,
  • Patient is unable to fully understand the study requirements and provide informed consent.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cefazolin
For the control group, cefazolin will be drawn into a 1 mL syringe and 0.5 mL will be injected with a 30-gauge needle into the subconjunctival space. This will be performed at the end of the retinal surgery.
Drug: Cefazolin
cephalosporin antibiotic
Active Comparator: Cefazolin + Lidocaine
For the comparator group, the cefazolin and 0.2 mL lidocaine 2% will be mixed together in the same 1 mL syringe and 0.5 mL of the mixed solution injected with a 30-gauge needle into the subconjunctival space. This will be performed at the end of the retinal surgery surgery.
Drug: Cefazolin
cephalosporin antibiotic
Drug: Lidocaine
local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score
Time Frame: 1 year
The change in numerical pain scale scores pre-and-post sub-conjunctival cefazolin administration for patients either receiving cefazolin alone versus patients receiving a combination of cefazolin and 2% lidocaine.
1 year

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Wai-Ching Lam, MD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CefazolinPain

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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