Postoperative Pain Control Following Vitreoretinal Surgery

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995045
• Other study ID #: IRB00053514
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2013
• Last updated: December 28, 2015
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Proliferative Vitreoretinopathy
• Retinal Detachment
• Retinoschisis

Intervention

Drug:
• Triamcinolone
Retrobulbar anesthesia
• Bupivicaine Hydrochloride
Retrobulbar anesthesia

Locations

Country	Name	City	State
United States	Emory University Eye Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long term monitoring of side effects	After post-operarative day 1, other meaningful potential side effects will be monitored at standard of care visits in both groups regarding raise in introcular pressure, increased pain levels, wound healing , and infection.	30 days	Yes
Primary	Subjective pain levels on a 10. scale questionnaire	The primary Outcome Measure of this study is to compare pain levels on postoperative day 1 in patients receiving triamcinolone acetonide with retrobulbar anesthesia versus retrobulbar anesthesia alone.	Post operative day 1	No
Secondary	Dosage of pain medication	1. Total amount of oral analgesics taken in the first 24 hours	Post operative day 1	No
Secondary	Measurements of ocular motility	2. Effects of the retrobulbar injections on ocular motility	Post operative day 1	No