Postoperative Pain Control Following Vitreoretinal Surgery

Emory University

Status and phase: Completed; Phase 4

Conditions: Proliferative Vitreoretinopathy; Retinal Detachment; Retinoschisis

Treatments: Drug: Triamcinolone; Drug: Bupivicaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01995045

IRB00053514

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Bupivicaine & Triamcinolone

Experimental group

Description:

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

Treatment:

Drug: Bupivicaine Hydrochloride

Drug: Triamcinolone

Bupivicaine

Active Comparator group

Description:

Retrobulbar anesthesia with Bupivicaine Hydrochloride

Treatment:

Drug: Bupivicaine Hydrochloride