Postoperative Pain Control Following Vitreoretinal Surgery
|Retinal Detachment Proliferative Vitreoretinopathy Retinoschisis||Drug: Triamcinolone Drug: Bupivicaine Hydrochloride||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
|Official Title:||The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery|
- 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.
- 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).
|Study Start Date:||July 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Bupivicaine & Triamcinolone
Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Other Names:Drug: Bupivicaine Hydrochloride
Other Name: Marcaine
Active Comparator: Bupivicaine
Retrobulbar anesthesia with Bupivicaine Hydrochloride
Drug: Bupivicaine Hydrochloride
Other Name: Marcaine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01995045
|United States, Georgia|
|Emory University Eye Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Timothy W Olsen, MD||Emory University|