Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain

NCT02324166 | Unknown Phase 4

• 1 other identifier: CefazolinPain
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitreoretinal Surgery; Endophthalmitis

Keywords

cefazolin; lidocaine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cefazolin

ACTIVE COMPARATOR

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

Cefazolin + Lidocaine

ACTIVE COMPARATOR

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; Drug: Lidocaine

Interventions

Cefazolin DRUG

cephalosporin antibiotic

Cefazolin; Cefazolin + Lidocaine

Lidocaine DRUG

local anesthetic

Cefazolin + Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (7)

• 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.

  PMID: 24420916 BACKGROUND

• 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.

  PMID: 24686917 BACKGROUND

• 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.

  PMID: 23857416 BACKGROUND

• 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.

  PMID: 22560416 BACKGROUND

• 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.

  PMID: 11226781 BACKGROUND

• 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.

  PMID: 15808246 BACKGROUND

• 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.

  PMID: 19126370 BACKGROUND

MeSH Terms

Conditions

Endophthalmitis

Interventions

Cefazolin; Lidocaine

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Wai-Ching Lam, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wai-Ching Lam, MD

CONTACT

4166035376; waiching.lam@utoronto.ca

Robert Devenyi, MD

CONTACT

416 603 5602; nicole.mclaren@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor University of Toronto, Residency Program Director Dept. of Ophthalmology, Continuing Medical Education

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: December 24, 2014

Record last verified: 2014-12