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Postoperative Pain Control Following Vitreoretinal Surgery

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Detachment; Proliferative Vitreoretinopathy; Retinoschisis

Intervention: Triamcinolone (Drug); Bupivicaine Hydrochloride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Timothy W Olsen, MD, Principal Investigator, Affiliation: Emory University

Overall contact:
Timothy W Olsen, MD, Phone: 404-778-5825, Email: tolsen@emory.edu

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.

Clinical Details

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

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

Primary outcome: Subjective pain levels on a 10. scale questionnaire

Secondary outcome:

Dosage of pain medication

Measurements of ocular motility

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

Minimum age: 18 Years. Maximum age: 89 Years. Gender(s): Both.

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)

Locations and Contacts

Timothy W Olsen, MD, Phone: 404-778-5825, Email: tolsen@emory.edu

Emory University Eye Center, Atlanta, Georgia 30322, United States; Recruiting
Alcides F Filho, MD, Phone: 404-778-2421, Email: afilho@emory.edu
Timothy W Olsen, MD, Principal Investigator
Additional Information

Related publications:

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.

Starting date: July 2012
Last updated: May 21, 2015

Page last updated: August 23, 2015

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