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Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02324166
Enrollment
54
Registered
2014-12-24
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2014-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endophthalmitis, Vitreoretinal Surgery

Keywords

cefazolin, lidocaine

Brief summary

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.

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.

Interventions

DRUGCefazolin

cephalosporin antibiotic

DRUGLidocaine

local anesthetic

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Score1 yearThe 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.

Contacts

Primary ContactWai-Ching Lam, MD
waiching.lam@utoronto.ca4166035376
Backup ContactRobert Devenyi, MD
nicole.mclaren@uhn.ca416 603 5602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026