Phase 4
N=14
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
Retinal Detachment
Bottom Line
View on ClinicalTrials.gov: NCT04701593 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Post Operative Pain Day 1 — 2.2; 1.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triamcinolone Acetonide 40mg/mL (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Pain Day 1 |
2.2; 1.0 | — |
| SECONDARY Post Operative Pain Week 1 |
0.8; 0 | — |
| SECONDARY Pain Medication Use (Tylenol in mg) |
3125; 2403 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04701593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.