Postoperative Pain Control Following Vitreoretinal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Timothy W. Olsen, Emory University
ClinicalTrials.gov Identifier:
NCT01995045
First received: November 10, 2013
Last updated: May 21, 2014
Last verified: May 2014
  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.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivicaine & Triamcinolone
Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Drug: Triamcinolone
Other Names:
  • Kenalog
  • Triamcinolone Acetonide
Drug: Bupivicaine Hydrochloride
Other Name: Marcaine
Active Comparator: Bupivicaine
Retrobulbar anesthesia with Bupivicaine Hydrochloride
Drug: Bupivicaine Hydrochloride
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
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

Contacts
Contact: Timothy W Olsen, MD 404-778-5825 tolsen@emory.edu
Contact: Alcides F Filho, MD 404-778-2421 afilho@emory.edu

Locations
United States, Georgia
Emory University Eye Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alcides F Filho, MD    404-778-2421    afilho@emory.edu   
Principal Investigator: Timothy W Olsen, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Timothy W Olsen, MD Emory University
  More Information

No publications provided

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: May 21, 2014
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:
Retinal Detachment
Pain, Postoperative
Retinoschisis
Vitreoretinopathy, Proliferative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Retinal Diseases
Eye Diseases
Retinal Degeneration
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 26, 2014