Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

NCT04701593 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-377
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Detachment

Keywords

Scleral Buckle; Triamcinolone Acetonide

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain Day 1

  11-point Numerical Rating Scale (0-10, 10 being highest level of pain)

  1 Day Post-Op

Secondary Outcomes (2)

• Post Operative Pain Week 1

  1 Week Post-Op

• Pain Medication Use (Tylenol in mg)

  Cumulative amount used was assessed at one week after operation

Study Arms (2)

Control

NO INTERVENTION

No additional drug given

Experimental (Triamcinolone Acetonide)

EXPERIMENTAL

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

Interventions

Triamcinolone Acetonide 40mg/mL DRUG

Sub-tenon irrigation 1cc

Also known as: Kenalog

Experimental (Triamcinolone Acetonide)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Vistar Eye Centers

Roanoke, Virginia, 24019, United States

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Vishak John
• Organization: Virginia Tech

vishakjohn@vt.edu

(540) 855-5100

Study Officials

• Vishak J John, MD

  Virginia Tech, Vistar Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: January 3, 2020
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: July 23, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)