Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Study Overview
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Brief Summary
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PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery. METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.

Official Title
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Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: Triamcinolone Acetonide 40mg/mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction Exclusion Criteria: Advanced Glaucoma History of corticosteroid responsive elevation in IOP Allergy to Triamcinolone Acetonide or other corticosteroids Pre-existing chronic pain disorders Herpes zoster Prior corneal allograft Allergy to local anesthetic or penicillin Patients unable to consent on own behalf Patients unable to communicate pain and nausea levels Pregnancy Incarceration

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No additional drug given | |
| Experimental: Experimental (Triamcinolone Acetonide)<br>receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation | Drug: Triamcinolone Acetonide 40mg/mL<br>* Sub-tenon irrigation 1cc<br>* Other names: Kenalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Day 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | 1 Day Post-Op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Week 1 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | 1 Week Post-Op | 
| Post Operative Pain Month 6 | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) | 6 Months Post-Op | 
| Nausea/Vomiting Score Day 1 | Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting) | 1 Day Post-Op | 
| Nausea/Vomiting Score Week 1 | Standard 7-pt scale for nausea and vomiting (0-6, 6 being most nausea/vomiting) | 1 Week Post-Op | 
| Pain Medication Use Day 1 | Pill-Count | 1 Day Post-Op | 
| Pain Medication Use Week 1 | Pill-Count | 1 Week Post-Op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scleral Buckle, Triamcinolone Acetonide