Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701593
• Other study ID #: 19-377
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2020
• Est. completion date: October 20, 2022

Study information

• Verified date: February 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Drug:
• Triamcinolone Acetonide 40mg/mL
Sub-tenon irrigation 1cc

Locations

Country	Name	City	State
United States	Vistar Eye Centers	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Pain Day 1	11-point Numerical Rating Scale (0-10, 10 being highest level of pain)	1 Day Post-Op
Secondary	Post Operative Pain Week 1	11-point Numerical Rating Scale (0-10, 10 being highest level of pain)	1 Week Post-Op
Secondary	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
Secondary	Pain Medication Use Week 1	Pill-Count	1 Week Post-Op