Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2022-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Postoperative Pain Control Following Vitreoretinal Surgery

NCT01995045

Retinal Detachment Proliferative Vitreoretinopathy Retinoschisis

COMPLETED PHASE4

Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy

NCT00532415

Vitrectomy

COMPLETED PHASE3

Triamcinolone Versus Topical Treatment in Post Operative Phacoemulsification

NCT00789971

Ocular Inflammation

COMPLETED NA

Cataract Surgery With Intracameral Triamcinolone in Infants

NCT01800708

Cataract

COMPLETED NA

Triamcinolone Assisted Anterior Vitrectomy

NCT01051648

Vitrectomy Cataract

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No additional drug given

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental (Triamcinolone Acetonide)

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

Group Type EXPERIMENTAL

Triamcinolone Acetonide 40mg/mL

Intervention Type DRUG

Sub-tenon irrigation 1cc

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone Acetonide 40mg/mL

Sub-tenon irrigation 1cc

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kenalog

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No