Clinical Trial: Postoperative Pain Control Following Vitreoretinal Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Emory University

Current Primary Outcome: 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.


Original Primary Outcome: The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]

The primary Outcome Measure of this study is to compare pain levels on postoperative day 1 in patients receiving triamcinolone acetonide with retrobulbar anesthesia versus retrobulbar anesthesia alone.


Current Secondary Outcome:

  • Mean Acetaminophen Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean acetaminophen use post surgery in milligrams(mg).
  • Mean Hydrocodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean hydrocodone use post surgery in milligrams(mg).
  • Mean Oxycodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean oxycodone use post surgery in milligrams(mg).


Original Secondary Outcome:

  • The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]
    1. Total amount of oral analgesics taken in the first 24 hours
  • The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]
    2. Effects on ocular motility


Information By: Emory University

Dates:
Date Received: November 10, 2013
Date Started: July 2012
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017