CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 14 enrolled
Drug / intervention
Triamcinolone Acetonide 40mg/mLdrug
Likely dose
Triamcinolone Acetonide 40mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04701593
NCT04701593Phase 4Completed

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

Virginia Polytechnic Institute and State University·interventional·Posted Jan 8, 2021·Updated Jul 23, 2024

In Brief

A Phase 4 clinical trial evaluating Triamcinolone Acetonide 40mg/mL for Retinal Detachment. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJan 8, 2021
Enrollment StartJan 3, 2020
Primary CompletionOct 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 5.5 years ago

Interventions

Triamcinolone Acetonide 40mg/mLdrug

Sub-tenon irrigation 1cc