Retinal Detachment
Conditions
Keywords
Scleral Buckle, Triamcinolone Acetonide
Brief summary
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery. METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.
Interventions
Sub-tenon irrigation 1cc
Sponsors
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction
Exclusion criteria
* Advanced Glaucoma * History of corticosteroid responsive elevation in IOP * Allergy to Triamcinolone Acetonide or other corticosteroids * Pre-existing chronic pain disorders * Herpes zoster * Prior corneal allograft * Allergy to local anesthetic or penicillin * Patients unable to consent on own behalf * Patients unable to communicate pain and nausea levels * Pregnancy * Incarceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Day 1 | 1 Day Post-Op | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Week 1 | 1 Week Post-Op | 11-point Numerical Rating Scale (0-10, 10 being highest level of pain) |
| Pain Medication Use (Tylenol in mg) | Cumulative amount used was assessed at one week after operation | Amount of Tylenol used (in mg) cumulatively over one week after the operation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No additional drug given | 5 |
| Experimental (Triamcinolone Acetonide) receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation
Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc | 9 |
| Total | 14 |
Baseline characteristics
| Characteristic | Control | Experimental (Triamcinolone Acetonide) | Total |
|---|---|---|---|
| Age, Customized 20-40 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Customized <20 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 40-65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Customized 65+ years | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 9 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 5 participants | 9 participants | 14 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 9 |
| other Total, other adverse events | 0 / 5 | 0 / 9 |
| serious Total, serious adverse events | 0 / 5 | 0 / 9 |
Outcome results
Primary
Post Operative Pain Day 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Time frame: 1 Day Post-Op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Post Operative Pain Day 1 | 2.2 score on a scale |
| Experimental (Triamcinolone Acetonide) | Post Operative Pain Day 1 | 1.0 score on a scale |
Secondary
Pain Medication Use (Tylenol in mg)
Amount of Tylenol used (in mg) cumulatively over one week after the operation
Time frame: Cumulative amount used was assessed at one week after operation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Pain Medication Use (Tylenol in mg) | 3125 milligrams |
| Experimental (Triamcinolone Acetonide) | Pain Medication Use (Tylenol in mg) | 2403 milligrams |
Secondary
Post Operative Pain Week 1
11-point Numerical Rating Scale (0-10, 10 being highest level of pain)
Time frame: 1 Week Post-Op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Post Operative Pain Week 1 | 0.8 score on a scale |
| Experimental (Triamcinolone Acetonide) | Post Operative Pain Week 1 | 0 score on a scale |