Vitreoretinal SurgeryPhase 4NCT02324166
Cefazolin-Lidocaine Combination Solution to Reduce Antibiotic Pain
A Phase 4 study testing Cefazolin and Lidocaine in people with Vitreoretinal Surgery and Endophthalmitis, run by University Health Network, Toronto.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreoretinal Surgery, Endophthalmitis
- What is being tested?
- Cefazolin and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient is cognitively incapable of performing the study,
- Patient is unable to fully understand the study requirements and provide informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Vitreoretinal Surgery, Endophthalmitis
- Being tested
- Cefazolin, Lidocaine
- Keywords
- cefazolin, lidocaine
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
cephalosporin antibiotic
LidocaineDrug
local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cefazolin; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Vitreoretinal SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wai-Ching Lam, University Health Network, Toronto
- Investigators
- Wai-Ching Lam, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324166
- Sponsor's protocol ID
- CefazolinPain
- Status last verified
- Dec 2014
- First submitted
- 18 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24420916Park 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.
PubMed 24686917Gower 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.
PubMed 23857416Ong-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.
PubMed 22560416Kayarkar 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.
PubMed 11226781Lai 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.
PubMed 15808246Younger 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.
PubMed 19126370
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefazolin-Lidocaine Solution for Reducing Pain Associated With Subconjunctival Antibiotic Prophylaxis in Vitreo-Retinal Surgery
- ClinicalTrials.gov ID
- NCT02324166
- Acronym / sponsor ID
- CefazolinPain
- Conditions
- Vitreoretinal Surgery, Endophthalmitis
- Keywords
- cefazolin, lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Active comparator | Drug: CefazolinFor 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 + Lidocaine | Active comparator | Drug: Cefazolin, Drug: LidocaineFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient is cognitively incapable of performing the study,
- Patient is unable to fully understand the study requirements and provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolincephalosporin antibiotic | Drug | Cefazolin, Cefazolin + Lidocaine |
| Lidocainelocal anesthetic | Drug | Cefazolin + Lidocaine |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
- Background: PubMed 24420916Park 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.
- Background: PubMed 24686917Park 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.
- Background: PubMed 23857416Gower 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.
- Background: PubMed 22560416Ong-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.
- Background: PubMed 11226781Kayarkar 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.
- Background: PubMed 15808246Lai 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.
- Background: PubMed 19126370Younger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai-Ching Lam, MD principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin and Lidocaine in people with Vitreoretinal Surgery and Endophthalmitis, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wai-Ching Lam, MD (4166035376, waiching.lam@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324166, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.