Using Intraoperative Triamcinolone Acetonide Irrigation to Reduce Post-Operative Pain From Scleral Buckle Surgery
| Registry | NCT04701593 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 14 (Actual) |
| Sponsor | Virginia Polytechnic Institute and State University (Other) |
| Conditions | Retinal Detachment |
| Interventions | Triamcinolone Acetonide 40mg/mL (Drug) |
| Dates | start 2020-01-03, primary completion 2022-10-20, completion 2022-10-20, first posted 2021-01-08, last updated 2024-07-23 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | No intervention | No additional drug given | |
| Experimental (Triamcinolone Acetonide) | Experimental | Drug: Triamcinolone Acetonide 40mg/mL | 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 |
Sex: All, ages: 19 Years to any
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
| Milestone | Control | Experimental (Triamcinolone Acetonide) |
|---|---|---|
| Started | 5 | 9 |
| Completed | 5 | 9 |
| Not completed | 0 | 0 |
Time frame: 6 months after experimental treatment
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Control | 0/5 (0.0%) | 0/5 (0.0%) | 0/5 (0.0%) |
| Experimental (Triamcinolone Acetonide) | 0/9 (0.0%) | 0/9 (0.0%) | 0/9 (0.0%) |
| Term | Organ system | Control | Experimental (Triamcinolone Acetonide) |
|---|---|---|---|
| Infection | Eye disorders | 0/5 | 0/9 |
| Facility | City | Country | Status |
|---|---|---|---|
| Vistar Eye Centers | Roanoke, Virginia | United States |