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Clinical Trials/NCT04701593
NCT04701593
Completed
Phase 4

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

Virginia Polytechnic Institute and State University1 site in 1 country14 target enrollmentJanuary 3, 2020

Overview

Phase
Phase 4
Intervention
Triamcinolone Acetonide 40mg/mL
Conditions
Retinal Detachment
Sponsor
Virginia Polytechnic Institute and State University
Enrollment
14
Locations
1
Primary Endpoint
Post Operative Pain Day 1
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2020
End Date
October 20, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

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

Intervention: Triamcinolone Acetonide 40mg/mL

Outcomes

Primary Outcomes

Post Operative Pain Day 1

Time Frame: 1 Day Post-Op

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

Secondary Outcomes

  • Pain Medication Use (Tylenol in mg)(Cumulative amount used was assessed at one week after operation)
  • Post Operative Pain Week 1(1 Week Post-Op)

Study Sites (1)

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