Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Phase 4

Completed

• Conditions: Retinal Detachment
• Interventions: Drug: Triamcinolone Acetonide 40mg/mL

• Registration Number: NCT04701593
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-03
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-08
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Results First Submitted: 2023-07-11
• Results First Submitted QC: 2024-02-29
• Results First Posted: 2024-03-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental (Triamcinolone Acetonide)	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

Primary Outcome Measures

Name	Time	Method
Post Operative Pain Day 1	1 Day Post-Op	11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

Secondary Outcome Measures

Name	Time	Method
Pain Medication Use (Tylenol in mg)	Cumulative amount used was assessed at one week after operation	Amount of Tylenol used (in mg) cumulatively over one week after the operation
Post Operative Pain Week 1	1 Week Post-Op	11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

Trial Locations

Locations (1)

Vistar Eye Centers; 🇺🇸 Roanoke, Virginia, United States