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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivicaine & Triamcinolone | Experimental | Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide |
|
| Bupivicaine | Active Comparator | Retrobulbar anesthesia with Bupivicaine Hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Retrobulbar anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Score | The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain. | Post-Operative Day 1 (Up to 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Acetaminophen Intake | The mean acetaminophen use post surgery in milligrams(mg). | Post Surgery (Up to 24 hours) |
| Mean Hydrocodone Intake | The mean hydrocodone use post surgery in milligrams(mg). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy W Olsen, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Eye Center | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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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Of the 58 participants recruited for the study, data for 57 participants were analyzed. Data for one participant was not available for analysis.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Post-Operative Day 1 (Up to 24 hours) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivicaine & Triamcinolone | Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide Triamcinolone: Retrobulbar anesthesia Bupivicaine Hydrochloride: Retrobulbar anesthesia |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular Pressure | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy Olsen | Emory University | 404-778-4996 | tolsen@emory.edu |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D018630 | Vitreoretinopathy, Proliferative |
| D041441 | Retinoschisis |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Bupivicaine Hydrochloride | Drug | Retrobulbar anesthesia |
|
|
| Post Surgery (Up to 24 hours) |
| Mean Oxycodone Intake | The mean oxycodone use post surgery in milligrams(mg). | Post Surgery (Up to 24 hours) |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Mean Acetaminophen Intake | The mean acetaminophen use post surgery in milligrams(mg). | Posted | Mean | Standard Deviation | milligrams | Post Surgery (Up to 24 hours) |
|
|
|
| Secondary | Mean Hydrocodone Intake | The mean hydrocodone use post surgery in milligrams(mg). | Posted | Mean | Standard Deviation | milligrams | Post Surgery (Up to 24 hours) |
|
|
|
| Secondary | Mean Oxycodone Intake | The mean oxycodone use post surgery in milligrams(mg). | Posted | Mean | Standard Deviation | milligrams | Post Surgery (Up to 24 hours) |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Bupivicaine | Retrobulbar anesthesia with Bupivicaine Hydrochloride Bupivicaine Hydrochloride: Retrobulbar anesthesia | 0 | 28 | 1 | 28 |
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |