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Postoperative Pain Control Following Vitreoretinal Surgery

Primary Purpose

Retinal Detachment, Proliferative Vitreoretinopathy, Retinoschisis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone
Bupivicaine Hydrochloride
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retinal Detachment focused on measuring Retina, Vitreoretinal, Surgery

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Emory University Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bupivicaine & Triamcinolone

Bupivicaine

Arm Description

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

Retrobulbar anesthesia with Bupivicaine Hydrochloride

Outcomes

Primary Outcome Measures

Mean Pain Score
The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.

Secondary Outcome Measures

Mean Acetaminophen Intake
The mean acetaminophen use post surgery in milligrams(mg).
Mean Hydrocodone Intake
The mean hydrocodone use post surgery in milligrams(mg).
Mean Oxycodone Intake
The mean oxycodone use post surgery in milligrams(mg).

Full Information

First Posted
November 10, 2013
Last Updated
February 16, 2017
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01995045
Brief Title
Postoperative Pain Control Following Vitreoretinal Surgery
Official Title
The Effects of Triamcinolone Acetonide With Retrobulbar Anesthesia on Postoperative Pain Control Following Vitreoretinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Proliferative Vitreoretinopathy, Retinoschisis
Keywords
Retina, Vitreoretinal, Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivicaine & Triamcinolone
Arm Type
Experimental
Arm Description
Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Arm Title
Bupivicaine
Arm Type
Active Comparator
Arm Description
Retrobulbar anesthesia with Bupivicaine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Kenalog, Triamcinolone Acetonide
Intervention Description
Retrobulbar anesthesia
Intervention Type
Drug
Intervention Name(s)
Bupivicaine Hydrochloride
Other Intervention Name(s)
Marcaine
Intervention Description
Retrobulbar anesthesia
Primary Outcome Measure Information:
Title
Mean Pain Score
Description
The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.
Time Frame
Post-Operative Day 1 (Up to 24 hours)
Secondary Outcome Measure Information:
Title
Mean Acetaminophen Intake
Description
The mean acetaminophen use post surgery in milligrams(mg).
Time Frame
Post Surgery (Up to 24 hours)
Title
Mean Hydrocodone Intake
Description
The mean hydrocodone use post surgery in milligrams(mg).
Time Frame
Post Surgery (Up to 24 hours)
Title
Mean Oxycodone Intake
Description
The mean oxycodone use post surgery in milligrams(mg).
Time Frame
Post Surgery (Up to 24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy W Olsen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
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Postoperative Pain Control Following Vitreoretinal Surgery

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