Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Virginia Polytechnic Institute and State University

Status and phase: Completed; Phase 4

Conditions: Retinal Detachment

Treatments: Drug: Triamcinolone Acetonide 40mg/mL

Study type: Interventional

Funder types: Other

Identifiers

NCT04701593

19-377

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

Control

No Intervention group

Description:

No additional drug given

Experimental (Triamcinolone Acetonide)

Experimental group

Description:

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

Treatment:

Drug: Triamcinolone Acetonide 40mg/mL