Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

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

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 Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Drug: Triamcinolone Acetonide 40mg/mL

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Parth R Vaidya; Phone Number: 3363911953; Email: vaidpr14@vt.edu
• Study Contact Backup: Name: Vishak J John, MD; Phone Number: (336) 703-7429; Email: Vishakjohn@vistareye.com

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24019
      • Vistar Eye Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No additional drug given
Experimental: 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	Drug: Triamcinolone Acetonide 40mg/mL; Sub-tenon irrigation 1cc; Other Names: Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain Day 1	11-point Numerical Rating Scale (0-10, 10 being highest level of pain)	1 Day Post-Op

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Vishak J John, MD, Virginia Tech, Vistar Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Scleral Buckle; Triamcinolone Acetonide
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 19-377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes