Proliferative Vitreoretinopathy, Retinal Detachment, Retinoschisis
Conditions
Keywords
Retina, 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.
Interventions
DRUGTriamcinolone
Retrobulbar anesthesia
DRUGBupivicaine Hydrochloride
Retrobulbar anesthesia
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Acetaminophen Intake | Post Surgery (Up to 24 hours) | The mean acetaminophen use post surgery in milligrams(mg). |
| Mean Hydrocodone Intake | Post Surgery (Up to 24 hours) | The mean hydrocodone use post surgery in milligrams(mg). |
| Mean Oxycodone Intake | Post Surgery (Up to 24 hours) | The mean oxycodone use post surgery in milligrams(mg). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Emory University Hospital between October 1, 2012 and June 17, 2016 who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both.
Pre-assignment details
Of the 58 participants recruited for the study, data for 57 participants were analyzed. Data for one participant was not available for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Bupivicaine & Triamcinolone Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery. | 29 |
| Salt Solution, Bupivacaine, and Cefazolin Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery. | 28 |
| Total | 57 |
Baseline characteristics
| Characteristic | Bupivicaine & Triamcinolone | Salt Solution, Bupivacaine, and Cefazolin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 6 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 22 Participants | 43 Participants |
| Region of Enrollment United States | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 21 Participants | 20 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 29 | 1 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Mean Pain Score
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine & Triamcinolone | Mean Pain Score | 2.9 units on a scale | Standard Deviation 2.8 |
| Salt Solution, Bupivacaine, and Cefazolin | Mean Pain Score | 3.8 units on a scale | Standard Deviation 2.8 |
Secondary
Mean Acetaminophen Intake
The mean acetaminophen use post surgery in milligrams(mg).
Time frame: Post Surgery (Up to 24 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine & Triamcinolone | Mean Acetaminophen Intake | 819 milligrams | Standard Deviation 998 |
| Salt Solution, Bupivacaine, and Cefazolin | Mean Acetaminophen Intake | 962 milligrams | Standard Deviation 839 |
Secondary
Mean Hydrocodone Intake
The mean hydrocodone use post surgery in milligrams(mg).
Time frame: Post Surgery (Up to 24 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine & Triamcinolone | Mean Hydrocodone Intake | .7 milligrams | Standard Deviation 2.9 |
| Salt Solution, Bupivacaine, and Cefazolin | Mean Hydrocodone Intake | 2.8 milligrams | Standard Deviation 6 |
Secondary
Mean Oxycodone Intake
The mean oxycodone use post surgery in milligrams(mg).
Time frame: Post Surgery (Up to 24 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivicaine & Triamcinolone | Mean Oxycodone Intake | 6.7 milligrams | Standard Deviation 6.8 |
| Salt Solution, Bupivacaine, and Cefazolin | Mean Oxycodone Intake | 9.0 milligrams | Standard Deviation 12.9 |