Postoperative Pain Control Following Vitreoretinal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy W. Olsen, Emory University
ClinicalTrials.gov Identifier:
NCT01995045
First received: November 10, 2013
Last updated: December 28, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Retinal Detachment
Proliferative Vitreoretinopathy
Retinoschisis
Drug: Triamcinolone
Drug: Bupivicaine Hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Subjective pain levels on a 10. scale questionnaire [ Time Frame: Post operative day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dosage of pain medication [ Time Frame: Post operative day 1 ] [ Designated as safety issue: No ]
    1. Total amount of oral analgesics taken in the first 24 hours

  • Measurements of ocular motility [ Time Frame: Post operative day 1 ] [ Designated as safety issue: No ]
    2. Effects of the retrobulbar injections on ocular motility


Other Outcome Measures:
  • Long term monitoring of side effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 57
Study Start Date: July 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivicaine & Triamcinolone
Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Drug: Triamcinolone
Retrobulbar anesthesia
Other Names:
  • Kenalog
  • Triamcinolone Acetonide
Drug: Bupivicaine Hydrochloride
Retrobulbar anesthesia
Other Name: Marcaine
Active Comparator: Bupivicaine
Retrobulbar anesthesia with Bupivicaine Hydrochloride
Drug: Bupivicaine Hydrochloride
Retrobulbar anesthesia
Other Name: Marcaine

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

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995045

Locations
United States, Georgia
Emory University Eye Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Timothy W Olsen, MD Emory University
  More Information

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.

Responsible Party: Timothy W. Olsen, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01995045     History of Changes
Other Study ID Numbers: IRB00053514 
Study First Received: November 10, 2013
Last Updated: December 28, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Emory University:
Retina
Vitreoretinal
Surgery

Additional relevant MeSH terms:
Pain, Postoperative
Retinal Detachment
Retinoschisis
Vitreoretinopathy, Proliferative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Retinal Diseases
Eye Diseases
Retinal Degeneration
Anesthetics
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local

ClinicalTrials.gov processed this record on August 24, 2016