Postoperative Pain Control Following Vitreoretinal Surgery

NCT ID: NCT01995045

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Retinal Detachment; Proliferative Vitreoretinopathy; Retinoschisis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Bupivicaine & Triamcinolone

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

Group Type: EXPERIMENTAL

Triamcinolone

Intervention Type: DRUG

Retrobulbar anesthesia

Bupivicaine Hydrochloride

Intervention Type: DRUG

Retrobulbar anesthesia

Bupivicaine

Retrobulbar anesthesia with Bupivicaine Hydrochloride

Group Type: ACTIVE_COMPARATOR

Bupivicaine Hydrochloride

Intervention Type: DRUG

Retrobulbar anesthesia

Interventions

Triamcinolone

Retrobulbar anesthesia

Intervention Type: DRUG

Bupivicaine Hydrochloride

Retrobulbar anesthesia

Intervention Type: DRUG

Other Intervention Names

Kenalog; Triamcinolone Acetonide; Marcaine

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Timothy W. Olsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy W Olsen, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Eye Center

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

IRB00053514

Identifier Type: -

Identifier Source: org_study_id