Phase 4 N=57 Randomized Single-blind Prevention

Postoperative Pain Control Following Vitreoretinal Surgery

Retinal Detachment · Proliferative Vitreoretinopathy · Retinoschisis

Bottom Line

View on ClinicalTrials.gov: NCT01995045 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Mean Pain Score — 2.9; 3.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Triamcinolone (Drug); Bupivicaine Hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Pain Score	2.9; 3.8	—
SECONDARY Mean Acetaminophen Intake	819; 962	—
SECONDARY Mean Hydrocodone Intake	.7; 2.8	—
SECONDARY Mean Oxycodone Intake	6.7; 9.0	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01995045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.