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Completed

NCT Number: NCT01995045

Postoperative Pain Control Following Vitreoretinal Surgery

The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Eye Center

Atlanta, Georgia, 30322, United States

About this study

Currently, patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital receive a injection of local anesthesia behind the eye (retrobulbar) at the start of surgery to minimize discomfort felt during the surgery. At the end of surgery all patients receive a periocular antibiotic and steroid injection. Some patients also receive a retrobulbar injection of local anesthesia (bupivicaine) at the conclusion of surgery in order to decrease postoperative pain and discomfort.

It has been our observation that when the local anesthesia is combined with a steroid (triamcinolone acetonide) in a retrobulbar injection at the conclusion of surgery, patients tend to be pain free for longer intervals then when local anesthesia is used alone. The objective of this study is to evaluate if patients receiving triamcinolone acetonide combined with local anesthesia and antibiotic compared to those receiving local anesthesia and antibiotic alone do better with postoperative pain control.

All eligible patients undergoing vitreoretinal surgery at the Emory Eye Center and Emory University Hospital will be offered enrollment. About 60 patients will be invited to participate in this study. Patients will undergo standard of care surgery. At the conclusion of surgery, patients will receive a retrobulbar antibiotic and anesthetic as standard of care. Half of the patients will receive this mixture plus steroid and the other half will receive this mixture plus saline. On postoperative day 1, patients will be given a questionnaire to assess pain. Pain levels in the two groups will be compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing vitreoretinal surgery at the Emory Eye Center Ambulatory Surgery Center and Emory University Hospital by retina attending faculty surgeons

Exclusion criteria

  • Unable to verbalize level of pain control
  • Pediatric patients (<18 years old)
  • Glaucoma, ocular hypertension, or glaucoma suspects
  • Allergy to local anesthetic
  • Pre-existing chronic pain requiring narcotic pain medication
  • Drug addiction
  • Impaired periorbital sensation (history of herpes simplex, zoster, corneal graft)

Treatment and study plan

Triamcinolone

Drug

Retrobulbar anesthesia

Other names: Kenalog, Triamcinolone Acetonide

Bupivicaine Hydrochloride

Drug

Retrobulbar anesthesia

Other names: Marcaine

Primary outcomes

  1. Mean Pain Score

    Time frame: Post-Operative Day 1 (Up to 24 hours)

    The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.

Secondary outcomes

  1. Mean Acetaminophen Intake

    Time frame: Post Surgery (Up to 24 hours)

    The mean acetaminophen use post surgery in milligrams(mg).

  2. Mean Hydrocodone Intake

    Time frame: Post Surgery (Up to 24 hours)

    The mean hydrocodone use post surgery in milligrams(mg).

  3. Mean Oxycodone Intake

    Time frame: Post Surgery (Up to 24 hours)

    The mean oxycodone use post surgery in milligrams(mg).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2013
Registry last updated
Mar 21, 2017

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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