Clinical Trials Directory

Trials / Completed

CompletedNCT01995045

Postoperative Pain Control Following Vitreoretinal Surgery

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGTriamcinoloneRetrobulbar anesthesia
DRUGBupivicaine HydrochlorideRetrobulbar anesthesia

Timeline

Start date
2012-07-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2013-11-26
Last updated
2017-03-21
Results posted
2017-02-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01995045. Inclusion in this directory is not an endorsement.