Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain
NCT ID: NCT02324166
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
54 participants
INTERVENTIONAL
2015-01-31
2016-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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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.
Cefazolin
cephalosporin antibiotic
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.
Cefazolin
cephalosporin antibiotic
Lidocaine
local anesthetic
Interventions
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Cefazolin
cephalosporin antibiotic
Lidocaine
local anesthetic
Eligibility Criteria
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Inclusion Criteria
* 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 unable to fully understand the study requirements and provide informed consent.
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Wai-Ching Lam
Professor University of Toronto, Residency Program Director Dept. of Ophthalmology, Continuing Medical Education
Principal Investigators
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Wai-Ching Lam, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Central Contacts
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References
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Park JC, Ramasamy B, Shaw S, Prasad S, Ling RH. A prospective and nationwide study investigating endophthalmitis following pars plana vitrectomy: incidence and risk factors. Br J Ophthalmol. 2014 Apr;98(4):529-33. doi: 10.1136/bjophthalmol-2013-304485. Epub 2014 Jan 13.
Park JC, Ramasamy B, Shaw S, Ling RH, Prasad S. A prospective and nationwide study investigating endophthalmitis following pars plana vitrectomy: clinical presentation, microbiology, management and outcome. Br J Ophthalmol. 2014 Aug;98(8):1080-6. doi: 10.1136/bjophthalmol-2013-304486. Epub 2014 Mar 31.
Gower EW, Lindsley K, Nanji AA, Leyngold I, McDonnell PJ. Perioperative antibiotics for prevention of acute endophthalmitis after cataract surgery. Cochrane Database Syst Rev. 2013 Jul 15;7(7):CD006364. doi: 10.1002/14651858.CD006364.pub2.
Ong-Tone L, Bell A, Tan YY. Practice patterns of Canadian Ophthalmological Society members in cataract surgery: 2011 survey. Can J Ophthalmol. 2012 Apr;47(2):124-30. doi: 10.1016/j.jcjo.2012.01.012.
Kayarkar VV, Dinakaran S. Topical anesthesia for phacoemulsification and painless subconjunctival antibiotic injection. J Cataract Refract Surg. 2001 Feb;27(2):198-200. doi: 10.1016/s0886-3350(00)00564-2.
Lai MM, Lai JC, Lee WH, Huang JJ, Patel S, Ying HS, Melia M, Haller JA, Handa JT. Comparison of retrobulbar and sub-Tenon's capsule injection of local anesthetic in vitreoretinal surgery. Ophthalmology. 2005 Apr;112(4):574-9. doi: 10.1016/j.ophtha.2004.10.043.
Younger J, McCue R, Mackey S. Pain outcomes: a brief review of instruments and techniques. Curr Pain Headache Rep. 2009 Feb;13(1):39-43. doi: 10.1007/s11916-009-0009-x.
Other Identifiers
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CefazolinPain
Identifier Type: -
Identifier Source: org_study_id