Clinical trial NCT01995045: Postoperative Pain Control Following Vitreoretinal Surgery
Official title: The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Detachment
Proliferative Vitreoretinopathy
Retinoschisis
Keywords: Retina
Vitreoretinal
Surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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)

Primary outcomes:
measure: Mean Pain Score
timeFrame: Post-Operative Day 1 (Up to 24 hours)
Secondary outcomes:
measure: Mean Acetaminophen Intake
timeFrame: Post Surgery (Up to 24 hours)
measure: Mean Hydrocodone Intake
timeFrame: Post Surgery (Up to 24 hours)
measure: Mean Oxycodone Intake
timeFrame: Post Surgery (Up to 24 hours)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Eye Center
state: Georgia
Study officials:
affiliation: Emory University
name: Timothy W Olsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gioia L, Prandi E, Codnotti M, Casati A,et al Peribulbar anesthesia with either 0.75% ropivacaine or a 2% lidocaine and 0.5% bupivacaine mixture for vitreoretinal surgery: a double-blinded study. Anesth Analg(89: 739-742, 1999. Shende D, Sadhasivam S, Madan R. Effects of peribulbar bupivacaine as an adjunct to general anaesthesia on peri-operative outcome following retinal detachment surgery. Anaesthesia(55): 970-975, 2000. Morel J, Pascal J, Charier D, et al. Preoperative peribulbar block in patients undergoing retinal detachment surgery under general anesthesia: a randomized double-blind study. Anesth Analg (102): 1082-1087, 2006. Ghali AM, Btarny AM. The effect on outcome of peribulbar anesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia (65): 249-253, 2010. Chavan SB, Cummings EJ.