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Postoperative Pain Control Following Vitreoretinal Surgery

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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

Tracking Information
First Submitted Date  ICMJE November 10, 2013
First Posted Date  ICMJE November 26, 2013
Results First Submitted Date  ICMJE December 27, 2016
Results First Posted Date  ICMJE February 16, 2017
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
  • Mean Acetaminophen Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean acetaminophen use post surgery in milligrams(mg).
  • Mean Hydrocodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean hydrocodone use post surgery in milligrams(mg).
  • Mean Oxycodone Intake [ Time Frame: Post Surgery (Up to 24 hours) ]
    The mean oxycodone use post surgery in milligrams(mg).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]
    1. Total amount of oral analgesics taken in the first 24 hours
  • The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: Post operative day 1 ]
    2. Effects on ocular motility
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 25, 2013)
The Effects of Triamcinolone Acetonide with Retrobulbar Anesthesia on Postoperative Pain Control following Vitreoretinal Surgery [ Time Frame: 30 days ]
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.
 
Descriptive Information
Brief Title  ICMJE Postoperative Pain Control Following Vitreoretinal Surgery
Official Title  ICMJE The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Retinal Detachment
  • Proliferative Vitreoretinopathy
  • Retinoschisis
Intervention  ICMJE
  • Drug: Triamcinolone
    Retrobulbar anesthesia
    Other Names:
    • Kenalog
    • Triamcinolone Acetonide
  • Drug: Bupivicaine Hydrochloride
    Retrobulbar anesthesia
    Other Name: Marcaine
Study Arms  ICMJE
  • Experimental: Bupivicaine & Triamcinolone
    Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
    Interventions:
    • Drug: Triamcinolone
    • Drug: Bupivicaine Hydrochloride
  • Active Comparator: Bupivicaine
    Retrobulbar anesthesia with Bupivicaine Hydrochloride
    Intervention: Drug: Bupivicaine Hydrochloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2016)
58
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
60
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995045
Other Study ID Numbers  ICMJE IRB00053514
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Timothy W. Olsen, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy W Olsen, MD Emory University
PRS Account Emory University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP