Endophthalmitis Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University Health Network, Toronto |
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:CD006364. doi: 10.1002/14651858.CD006364.pub2. Review. — View Citation
Kayarkar VV, Dinakaran S. Topical anesthesia for phacoemulsification and painless subconjunctival antibiotic injection. J Cataract Refract Surg. 2001 Feb;27(2):198-200. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain Score | 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 | No |
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