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OpenTrials
Completed

NCT Number: NCT04701593

Using Triamcinolone Acetonide to Reduce Pain After 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vistar Eye Centers

Roanoke, Virginia, 24019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone Acetonide 40mg/mL

Drug

Sub-tenon irrigation 1cc

Other names: Kenalog

Primary outcomes

  1. 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

  1. Post Operative Pain Week 1

    Time frame: 1 Week Post-Op

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

  2. Pain Medication Use (Tylenol in mg)

    Time frame: Cumulative amount used was assessed at one week after operation

    Amount of Tylenol used (in mg) cumulatively over one week after the operation

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2021
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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