Postoperative Pain Control Following Vitreoretinal Surgery

Study Overview
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Brief Summary
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The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

Detailed Description
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Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. At the end of surgery all patients receive a periocular antibiotic and steroid injection. Some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort. It has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. The objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control. All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital will be offered enrollment. About 60 patients will be invited to participate in this study. Patients will undergo standard of care surgery. At the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. Half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. On postoperative day 1, patients will be given a questionnaire to assess pain. Pain levels in the two groups will be compared.

Official Title
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The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery

Conditions
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Retinal Detachment, Proliferative Vitreoretinopathy, Retinoschisis

Intervention / Treatment
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* Drug: Triamcinolone
* Drug: Bupivicaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons Exclusion Criteria: Unable to verbalize level of pain control Pediatric patients (<18 years old) Glaucoma, ocular hypertension, or glaucoma suspects Allergy to local anesthetic Pre-existing chronic pain requiring narcotic pain medication Drug addiction Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivicaine & Triamcinolone<br>Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide | Drug: Triamcinolone<br>* Retrobulbar anesthesia<br>* Other names: Triamcinolone Acetonide;Drug: Bupivicaine Hydrochloride<br>* Retrobulbar anesthesia<br>* Other names: Marcaine;|
| Active Comparator: Bupivicaine<br>Retrobulbar anesthesia with Bupivicaine Hydrochloride | Drug: Bupivicaine Hydrochloride<br>* Retrobulbar anesthesia<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain Score | The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain. | Post-Operative Day 1 (Up to 24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Acetaminophen Intake | The mean acetaminophen use post surgery in milligrams(mg). | Post Surgery (Up to 24 hours) | 
| Mean Hydrocodone Intake | The mean hydrocodone use post surgery in milligrams(mg). | Post Surgery (Up to 24 hours) | 
| Mean Oxycodone Intake | The mean oxycodone use post surgery in milligrams(mg). | Post Surgery (Up to 24 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retina, Vitreoretinal, Surgery