We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postoperative Pain Control Following Vitreoretinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995045
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 16, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy W. Olsen, Emory University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Proliferative Vitreoretinopathy Retinoschisis Drug: Triamcinolone Drug: Bupivicaine Hydrochloride Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean Pain Score [ Time Frame: Post-Operative Day 1 (Up to 24 hours) ]
    The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.


Secondary Outcome Measures :
  1. Mean Acetaminophen Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean acetaminophen use post surgery in milligrams(mg).

  2. Mean Hydrocodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean hydrocodone use post surgery in milligrams(mg).

  3. Mean Oxycodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean oxycodone use post surgery in milligrams(mg).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995045


Locations
Layout table for location information
United States, Georgia
Emory University Eye Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Timothy W Olsen, MD Emory University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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.

Layout table for additonal information
Responsible Party: Timothy W. Olsen, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT01995045    
Other Study ID Numbers: IRB00053514
First Posted: November 26, 2013    Key Record Dates
Results First Posted: February 16, 2017
Last Update Posted: March 21, 2017
Last Verified: February 2017
Keywords provided by Timothy W. Olsen, Emory University:
Retina
Vitreoretinal
Surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Detachment
Vitreoretinopathy, Proliferative
Retinoschisis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Retinal Diseases
Eye Diseases
Retinal Degeneration
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Bupivacaine
 Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action